Trial Outcomes & Findings for LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) (NCT NCT05035654)

NCT ID: NCT05035654

Last Updated: 2024-12-17

Results Overview

Product-related unexpected serious adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Through Week 28
• Results posted on: 2024-12-17

Participant Flow

2 subjects were randomized but did not receive the investigational product and are not included in the total count

Participant milestones

Measure	Part 1: LYR-220 Design 1 Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2:Bilateral Sham Procedure Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Overall Study STARTED	3	24	21
Overall Study COMPLETED	2	22	17
Overall Study NOT COMPLETED	1	2	4

Reasons for withdrawal

Measure	Part 1: LYR-220 Design 1 Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2:Bilateral Sham Procedure Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Overall Study Physician Decision	0	1	0
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	0	0	4
Overall Study Bilateral Dislodgement	1	0	0

Baseline Characteristics

2 subjects were randomized but did not receive the investigational product.

Baseline characteristics by cohort

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product.	0 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product.	0 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product.	0 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product.
Age, Categorical Between 18 and 65 years	2 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product.	23 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product.	18 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product.	43 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product.
Age, Categorical >=65 years	1 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product.	1 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product.	3 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product.	5 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product.
Age, Continuous	52 years STANDARD_DEVIATION 14.98 • n=3 Participants	48 years STANDARD_DEVIATION 12.91 • n=24 Participants	55 years STANDARD_DEVIATION 11.29 • n=21 Participants	51 years STANDARD_DEVIATION 12.49 • n=48 Participants
Sex: Female, Male Female	1 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product.	16 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product.	11 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product.	28 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product.
Sex: Female, Male Male	2 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product.	8 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product.	10 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product.	20 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Race (NIH/OMB) Asian	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	1 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	1 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	1 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	2 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	3 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Race (NIH/OMB) White	3 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	22 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	18 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	43 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Race (NIH/OMB) More than one race	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	1 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	1 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=24 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=21 Participants • 2 subjects were randomized but did not receive the investigational product	0 Participants n=48 Participants • 2 subjects were randomized but did not receive the investigational product
Region of Enrollment United States	3 Participants n=3 Participants	20 Participants n=24 Participants	21 Participants n=21 Participants	44 Participants n=48 Participants
Region of Enrollment Australia	0 Participants n=3 Participants	4 Participants n=24 Participants	0 Participants n=21 Participants	4 Participants n=48 Participants
BMI	35.35 kg/m² STANDARD_DEVIATION 6.69 • n=2 Participants • Subjects with non-missing height and/or weight.	30.65 kg/m² STANDARD_DEVIATION 5.68 • n=21 Participants • Subjects with non-missing height and/or weight.	33.71 kg/m² STANDARD_DEVIATION 8.63 • n=19 Participants • Subjects with non-missing height and/or weight.	32.26 kg/m² STANDARD_DEVIATION 7.23 • n=42 Participants • Subjects with non-missing height and/or weight.

PRIMARY outcome

Timeframe: Through Week 28

Population: Safety Analysis Set

Product-related unexpected serious adverse events

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Product-related Unexpected Serious Adverse Events	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Through Week 25

Population: PK Analysis Set Design 1- Part 1, PK Analysis Set Design 2 - Part 1; PK Analysis Set Design 2 - Part 2

Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25.

The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Plasma MF Concentrations 1-Hour Post	11.04 pg/mL Standard Deviation 0.04	—	18.11 pg/mL Standard Deviation 13.09
Plasma MF Concentrations Day 2	40.86 pg/mL Standard Deviation 5.98	135.83 pg/mL	61.02 pg/mL Standard Deviation 23.98
Plasma MF Concentrations Day 3	97.77 pg/mL	55.86 pg/mL Standard Deviation 28.70	46.00 pg/mL Standard Deviation 26.05
Plasma MF Concentrations Day 5	—	—	44.16 pg/mL Standard Deviation 19.60
Plasma MF Concentrations Day 8	68.34 pg/mL Standard Deviation 38.67	72.31 pg/mL Standard Deviation 19.15	58.87 pg/mL Standard Deviation 21.36
Plasma MF Concentrations Week 4	40.41 pg/mL Standard Deviation 25.99	68.90 pg/mL Standard Deviation 5.19	61.31 pg/mL Standard Deviation 34.97
Plasma MF Concentrations Week 12	15.14 pg/mL Standard Deviation 4.26	68.00 pg/mL Standard Deviation 20.96	50.17 pg/mL Standard Deviation 17.79
Plasma MF Concentrations Week 16	—	70.940 pg/mL	31.26 pg/mL Standard Deviation 17.06
Plasma MF Concentrations Week 20	7.58 pg/mL Standard Deviation 5.31	22.6 pg/mL Standard Deviation 1	20.17 pg/mL Standard Deviation 8.49
Plasma MF Concentrations Week 24	2.08 pg/mL Standard Deviation 2.14	11.52 pg/mL Standard Deviation 8.77	11.18 pg/mL Standard Deviation 12.96
Plasma MF Concentrations Week 25	—	—	NA pg/mL Standard Deviation NA Statistics at any individual timepoint were calculated if at least half of the subjects have valid values (ie not missing, quantifialble and not outside collection window). Actual sampling times that were outside the sampling time windows were excluded from concentration summary.

SECONDARY outcome

Timeframe: Through Week 28

Population: Safety Analysis Set

Percentage of subjects reporting treatment-emergent adverse events

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Adverse Events	1 Participants	23 Participants	16 Participants

SECONDARY outcome

Timeframe: Through Week 25

Population: Safety Analysis Set

Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Endoscopic Findings	0 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Through Week 25

Population: Safety Analysis Set

Percentage of subjects with clinically significant increase in IOP

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Ophthalmic Assessment: Intraocular Pressure (IOP) IOP in 1 or both eyes >23 mm Hg at Post Baseline	0 participants	0 participants	0 participants
Ophthalmic Assessment: Intraocular Pressure (IOP) An increase of IOP from Baseline in 1 or both eyes >=10 mm Hg	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Through Week 25

Population: Safety Analysis Set

Percentage of subjects with newly identified or worsened cataract in one or both eyes

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=3 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 Participants Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Ophthalmic Assessment: Cataract Newly Identified Cataract	0 Participants	1 Participants	0 Participants
Ophthalmic Assessment: Cataract Worsened Cataract	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Through Week 28

Population: Efficacy Analysis Set - Part 2

The 22-item Sino-Nasal Outcome Test (SNOT-22) questionnaire is a 22-item disease-specific quality of life instrument validated for use in CRS. Each symptom is scored as it has been over the past 2 weeks on a 6-point scale as follows: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.

The outcome measure is change from baseline in total patient-reported outcome score. The SNOT-22 total score is the sum of individual scores and ranges from 0 to 110. Higher scores indicate higher severity of symptoms.

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=13 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=9 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire	-30.1 Change from Baseline in SNOT-22 score Interval -74.0 to -2.0	-4.0 Change from Baseline in SNOT-22 score Interval -34.0 to 32.0	—

SECONDARY outcome

Timeframe: Through Week 28

Population: Efficacy Analysis Set - Part 2

Change from baseline in the average composite score over the preceeding 7 days of the 3 Cardinal Symptoms (3CS).The 3CS include: nasal blockage/obstruction/congestion, facial pain/ pressure, and anterior/posterior nasal discharge. The diary is completed daily by study participants throughout the study. Each symptom/each question is scored daily on a 0-3 scale as follows: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Outcome measures

Measure	Part 1: LYR-220 Design 1 n=21 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=21 Participants Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)	-1.68 Change from Baseline in 3CS Score Standard Deviation 2.33	-0.48 Change from Baseline in 3CS Score Standard Deviation 2.1	—

Adverse Events

Part 1: LYR-220 Design 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1 and Part 2: LYR-220 Design 2

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 2: Bilateral Sham Procedure

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1: LYR-220 Design 1 n=3 participants at risk Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1 LYR-220 Design 1: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1	Part 1 and Part 2: LYR-220 Design 2 n=24 participants at risk Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2 LYR-220 Design 2: LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2	Part 2: Bilateral Sham Procedure n=21 participants at risk Bilateral sham procedure control Bilateral sham procedure control: Bilateral sham procedure control
Infections and infestations Sinusitis	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	33.3% 8/24 • Number of events 11 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	19.0% 4/21 • Number of events 4 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Infections and infestations Acute Sinusitis	33.3% 1/3 • Number of events 1 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	25.0% 6/24 • Number of events 9 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	9.5% 2/21 • Number of events 4 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	16.7% 4/24 • Number of events 4 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	9.5% 2/21 • Number of events 3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Infections and infestations Bronchitis	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	16.7% 4/24 • Number of events 4 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	0.00% 0/21 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Infections and infestations Chronic Sinusitis	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	8.3% 2/24 • Number of events 2 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Infections and infestations COVID-19	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	12.5% 3/24 • Number of events 3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	0.00% 0/21 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	8.3% 2/24 • Number of events 2 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	8.3% 2/24 • Number of events 2 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	0.00% 0/21 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	8.3% 2/24 • Number of events 3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	0.00% 0/21 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Respiratory, thoracic and mediastinal disorders Nasal Odour	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	8.3% 2/24 • Number of events 2 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	0.00% 0/21 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.
Nervous system disorders Headache	0.00% 0/3 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	8.3% 2/24 • Number of events 2 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.	0.00% 0/21 • Treatment-emergent adverse events are reported from Day 1 through Week 28 (~ 7 months). Standard definition of adverse events and serious adverse events was used in the trial. All events were assesed for relationship to the study product and study procedure.

Additional Information

Senior Vice President, Clinical Affairs

Lyra Therapeutics

Phone: 617-393-4600

Email: lyraclinical@lyratx.com

Results disclosure agreements

• Principal investigator is a sponsor employee Except as approved by Sponsor, single center data will not be published before multicenter data, unless \>1 year has elapsed since completion of the Study. PI may publish single center data provided that PI shall: i) provide a copy of the publication to Sponsor at least 60 days in advance of submission for publication; ii) delete Sponsor Confidential Information and make other reasonable changes; and iii) delay submission by up to 90 additional days to permit intellectual property filings.
• Publication restrictions are in place

Restriction type: OTHER