Trial Outcomes & Findings for Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects (NCT NCT04334460)
NCT ID: NCT04334460
Last Updated: 2022-04-06
Results Overview
To evaluate time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Course of study; 28 days
Results posted on
2022-04-06
Participant Flow
Participant milestones
| Measure |
Active Group
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Full Enrollment
STARTED
|
81
|
39
|
|
Full Enrollment
COMPLETED
|
81
|
39
|
|
Full Enrollment
NOT COMPLETED
|
0
|
0
|
|
Full Analysis Set (FAS)
STARTED
|
81
|
39
|
|
Full Analysis Set (FAS)
COMPLETED
|
77
|
38
|
|
Full Analysis Set (FAS)
NOT COMPLETED
|
4
|
1
|
|
Safety Analysis Population
STARTED
|
81
|
39
|
|
Safety Analysis Population
COMPLETED
|
77
|
38
|
|
Safety Analysis Population
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Active Group
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Full Analysis Set (FAS)
Patients did not receive any study drug & are therefore excluded from the FAS.
|
4
|
1
|
|
Safety Analysis Population
Patients did not receive any study drug & are therefore excluded from the Safety analysis set.
|
4
|
1
|
Baseline Characteristics
The reason is due to missing data.
Baseline characteristics by cohort
| Measure |
Active Group
n=81 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=39 Participants
Placebo to Match (PTM) the active BLD-2660
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 12.97 • n=81 Participants
|
54.2 Years
STANDARD_DEVIATION 13.95 • n=39 Participants
|
52.2 Years
STANDARD_DEVIATION 13.31 • n=120 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=81 Participants
|
13 Participants
n=39 Participants
|
55 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=81 Participants
|
26 Participants
n=39 Participants
|
65 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=81 Participants
|
19 Participants
n=39 Participants
|
64 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=81 Participants
|
19 Participants
n=39 Participants
|
54 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=81 Participants
|
1 Participants
n=39 Participants
|
2 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=81 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=81 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=81 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=81 Participants
|
11 Participants
n=39 Participants
|
24 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=81 Participants
|
20 Participants
n=39 Participants
|
80 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=81 Participants
|
7 Participants
n=39 Participants
|
14 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=81 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=81 Participants
|
19 participants
n=39 Participants
|
59 participants
n=120 Participants
|
|
Region of Enrollment
Brazil
|
41 participants
n=81 Participants
|
20 participants
n=39 Participants
|
61 participants
n=120 Participants
|
|
APACHE II Score
|
6.5 units on a scale
STANDARD_DEVIATION 5.41 • n=71 Participants • The reason is due to missing data.
|
6.5 units on a scale
STANDARD_DEVIATION 4.84 • n=31 Participants • The reason is due to missing data.
|
6.5 units on a scale
STANDARD_DEVIATION 5.22 • n=102 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
1 - Not hospitalized
|
0 Participants
n=77 Participants • The reason is due to missing data.
|
0 Participants
n=38 Participants • The reason is due to missing data.
|
0 Participants
n=115 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
2 - Hospitalized, not requiring supplemental oxygen
|
6 Participants
n=77 Participants • The reason is due to missing data.
|
1 Participants
n=38 Participants • The reason is due to missing data.
|
7 Participants
n=115 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
3 - Hospitalized, requiring supplemental oxygen
|
60 Participants
n=77 Participants • The reason is due to missing data.
|
25 Participants
n=38 Participants • The reason is due to missing data.
|
85 Participants
n=115 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
4 - Hospitalized, on non-invasive ventilation or high flow oxygen device
|
6 Participants
n=77 Participants • The reason is due to missing data.
|
7 Participants
n=38 Participants • The reason is due to missing data.
|
13 Participants
n=115 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
5 - Hospitalized, on invasive mechanical ventilation or ECMO
|
0 Participants
n=77 Participants • The reason is due to missing data.
|
0 Participants
n=38 Participants • The reason is due to missing data.
|
0 Participants
n=115 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
6 - Death
|
0 Participants
n=77 Participants • The reason is due to missing data.
|
0 Participants
n=38 Participants • The reason is due to missing data.
|
0 Participants
n=115 Participants • The reason is due to missing data.
|
|
6-Point Ordinal Scale
7 - Missing
|
5 Participants
n=77 Participants • The reason is due to missing data.
|
5 Participants
n=38 Participants • The reason is due to missing data.
|
10 Participants
n=115 Participants • The reason is due to missing data.
|
|
SpO2/FiO2 Ratio
|
299.2 Ratio
STANDARD_DEVIATION 61.89 • n=72 Participants • The reason is due to missing data.
|
290.8 Ratio
STANDARD_DEVIATION 72.34 • n=37 Participants • The reason is due to missing data.
|
296.3 Ratio
STANDARD_DEVIATION 65.41 • n=109 Participants • The reason is due to missing data.
|
|
SARS-Cov-2 PCR Viral Load (copies/mL)
|
5703533.3 copies/mL
STANDARD_DEVIATION 30719776.01 • n=71 Participants • The reason is due to missing data.
|
553963.0 copies/mL
STANDARD_DEVIATION 2177374.66 • n=34 Participants • The reason is due to missing data.
|
4036053.4 copies/mL
STANDARD_DEVIATION 25348615.41 • n=105 Participants • The reason is due to missing data.
|
|
IL-6 (ng/mL)
|
12.9 ng/mL
STANDARD_DEVIATION 27.60 • n=70 Participants • The reason is due to missing data.
|
11.3 ng/mL
STANDARD_DEVIATION 13.10 • n=35 Participants • The reason is due to missing data.
|
12.4 ng/mL
STANDARD_DEVIATION 23.71 • n=105 Participants • The reason is due to missing data.
|
|
D-Dimer (ug/mL)
|
0.8 ug/mL
STANDARD_DEVIATION 0.70 • n=64 Participants • The reason is due to missing data.
|
0.8 ug/mL
STANDARD_DEVIATION 0.62 • n=33 Participants • The reason is due to missing data.
|
0.8 ug/mL
STANDARD_DEVIATION 0.67 • n=97 Participants • The reason is due to missing data.
|
PRIMARY outcome
Timeframe: Course of study; 28 daysPopulation: FAS Set
To evaluate time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first.
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Time to Recovery
|
5 days
Interval 3.0 to 6.0
|
4.5 days
Interval 4.0 to 6.0
|
PRIMARY outcome
Timeframe: 10 daysPopulation: FAS Set
To evaluate change in oxygenation in hospitalized adults with COVID-19 treated with BLD-2660. Measured by change from baseline to Day 10 or hospital discharge, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2)
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Change in Oxygenation
|
33.8 Ratio
Standard Error 17.10
|
66.8 Ratio
Standard Error 25.58
|
SECONDARY outcome
Timeframe: Course of study; 28 daysPopulation: Safety Set
To evaluate the safety and tolerability of BLD-2660 in the same population. Measured by incidence of TEAEs and serious adverse events (SAEs)
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of Subjects with >=1 TEAE
|
42 Participants
|
23 Participants
|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of Subjects with >=1 Treatment-Related TEAE
|
10 Participants
|
6 Participants
|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of Subjects with >=1 TEAE with Grade 3 or higher
|
12 Participants
|
9 Participants
|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of Subjects with >=1 TE SAE
|
9 Participants
|
9 Participants
|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of Subjects with >=1 Treatment-Related SAE
|
0 Participants
|
1 Participants
|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of Subjects with >=1 TEAE leading to discontinuation of study drug
|
2 Participants
|
5 Participants
|
|
Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs)
Number of fatal AEs
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysPopulation: FAS Set
Measured by time to discharge readiness
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Time to Discharge Readiness
|
7.0 Days
Interval 6.0 to 11.0
|
8.0 Days
Interval 5.0 to 22.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysMeasured by proportion of subjects ready to be discharged from the hospital during the 28-day study period following enrollment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysMeasured by time to resolution of fever below entry criteria for 24 hours in subjects with fever at baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysMeasured by duration (in days) of remdesivir use in subjects starting remdesivir within 24 hours of first dose of BLD-2660
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysPopulation: FAS Set
Measured by change from baseline to Days 10, 14, 21 and 28 in clinical status outcome using a 6-point ordinal scale
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Change in Clinical Status
Day 10/EOT · 2 - Hospitalized, not requiring supplemental oxygen
|
44 Participants
|
23 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 1 - Not hospitalized
|
56 Participants
|
21 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 2 - Hospitalized, not requiring supplemental oxygen
|
5 Participants
|
2 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 5 - Hospitalized, on invasive mechanical ventilation or ECMO
|
3 Participants
|
2 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 6 - Death
|
0 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 7 - Missing
|
9 Participants
|
11 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 5 - Hospitalized, on invasive mechanical ventilation or ECMO
|
3 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 28 · 1 - Not hospitalized
|
63 Participants
|
24 Participants
|
|
Change in Clinical Status
Day 28 · 2 - Hospitalized, not requiring supplemental oxygen
|
0 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 28 · 4 - Hospitalized, on non-invasive ventilation or high flow oxygen device
|
0 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 28 · 5 - Hospitalized, on invasive mechanical ventilation or ECMO
|
3 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 10/EOT · 1 - Not hospitalized
|
4 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 10/EOT · 3 - Hospitalized, requiring supplemental oxygen
|
20 Participants
|
8 Participants
|
|
Change in Clinical Status
Day 10/EOT · 4 - Hospitalized, on non-invasive ventilation or high flow oxygen device
|
3 Participants
|
3 Participants
|
|
Change in Clinical Status
Day 10/EOT · 5 - Hospitalized, on invasive mechanical ventilation or ECMO
|
5 Participants
|
2 Participants
|
|
Change in Clinical Status
Day 10/EOT · 6 - Death
|
0 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 10/EOT · 7 - Missing
|
1 Participants
|
2 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 3 - Hospitalized, requiring supplemental oxygen
|
1 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 14 (Follow-Up) · 4 - Hospitalized, on non-invasive ventilation or high flow oxygen device
|
3 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 1 - Not hospitalized
|
54 Participants
|
20 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 2 - Hospitalized, not requiring supplemental oxygen
|
2 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 3 - Hospitalized, requiring supplemental oxygen
|
1 Participants
|
1 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 4 - Hospitalized, on non-invasive ventilation or high flow oxygen device
|
0 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 6 - Death
|
0 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 21 (Follow-Up) · 7 - Missing
|
17 Participants
|
15 Participants
|
|
Change in Clinical Status
Day 28 · 3 - Hospitalized, requiring supplemental oxygen
|
1 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 28 · 6 - Death
|
0 Participants
|
0 Participants
|
|
Change in Clinical Status
Day 28 · 7 - Missing
|
10 Participants
|
12 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysPopulation: FAS Set
Measured by percentage of subjects reporting each 6-point ordinal scale of the clinical status outcome assessment.
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Percentage of Subjects in Each Category of the 6-point Ordinal Scale
Day 10 (EOT)
|
76 Participants
|
36 Participants
|
|
Percentage of Subjects in Each Category of the 6-point Ordinal Scale
Day 14 (Follow-Up)
|
68 Participants
|
27 Participants
|
|
Percentage of Subjects in Each Category of the 6-point Ordinal Scale
Day 21 (Follow-Up)
|
60 Participants
|
23 Participants
|
|
Percentage of Subjects in Each Category of the 6-point Ordinal Scale
Day 28
|
67 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysPopulation: FAS Set. Only participants in the FAS with data at the respective time point are summarized.
Measured by change from baseline to Days 10, 14, 21 and 28 in IL-6 in ng/mL measured by analytical assay
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Change in IL-6
Day 21
|
3.361 ng/L
Standard Deviation 6.6323
|
1.981 ng/L
Standard Deviation 1.9770
|
|
Change in IL-6
Day 10
|
5.606 ng/L
Standard Deviation 13.6212
|
4.592 ng/L
Standard Deviation 8.8388
|
|
Change in IL-6
Day 14
|
29.547 ng/L
Standard Deviation 196.4762
|
25.892 ng/L
Standard Deviation 82.0965
|
|
Change in IL-6
Day 28
|
6.639 ng/L
Standard Deviation 28.6087
|
2.649 ng/L
Standard Deviation 4.0756
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Course of study; 28 daysPopulation: FAS Set
Measured by change from baseline to Days 10, 14, 21 and 28 in D-dimer in ng/mL measured by analytical assay
Outcome measures
| Measure |
Active Group
n=77 Participants
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 Participants
Placebo: Placebo-to-Match BLD-2660
|
|---|---|---|
|
Change in D-dimer
Day 10
|
0.51 ug/mL
Interval 0.404 to 0.646
|
0.67 ug/mL
Interval 0.488 to 0.926
|
|
Change in D-dimer
Day 14
|
0.54 ug/mL
Interval 0.431 to 0.677
|
0.57 ug/mL
Interval 0.409 to 0.805
|
|
Change in D-dimer
Day 21
|
0.50 ug/mL
Interval 0.391 to 0.6529
|
0.56 ug/mL
Interval 0.398 to 0.783
|
|
Change in D-dimer
Day 28
|
0.57 ug/mL
Interval 0.456 to 0.719
|
0.41 ug/mL
Interval 0.295 to 0.574
|
Adverse Events
Active Group
Serious events: 9 serious events
Other events: 42 other events
Deaths: 2 deaths
Placebo Group
Serious events: 9 serious events
Other events: 23 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Active Group
n=77 participants at risk
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 participants at risk
Placebo to Match (PTM) the active BLD-2660
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Cardiac disorders
Cardiac arrest
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
General disorders
Pyrexia
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Infections and infestations
Sepsis
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Infections and infestations
Septic shock
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/77 • 6 months.
|
5.3%
2/38 • 6 months.
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.9%
3/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Vascular disorders
Shock
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
Other adverse events
| Measure |
Active Group
n=77 participants at risk
BLD-2660: BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
|
Placebo Group
n=38 participants at risk
Placebo to Match (PTM) the active BLD-2660
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Cardiac disorders
Angina pectoris
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Ear and labyrinth disorders
Ear congestion
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Eye disorders
Dry eye
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Gastrointestinal disorders
Nausea
|
7.8%
6/77 • 6 months.
|
18.4%
7/38 • 6 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
4/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
2/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Gastrointestinal disorders
Change of bowel habit
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Gastrointestinal disorders
Retching
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
General disorders
Fatigue
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
General disorders
Generalised oedema
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Infections and infestations
Fungal infection
|
2.6%
2/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Infections and infestations
Urinary tract candidiasis
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Investigations
Alanine aminotransferase increased
|
5.2%
4/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
4/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Investigations
Fibrin D dimer increased
|
2.6%
2/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
2/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Blood bicarbonate decreased
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Blood creatinine increased
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Blood glucose increased
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Blood potassium decreased
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Blood pressure increased
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Breath sounds abnormal
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Investigations
Transaminases increased
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Investigations
Troponin increased
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.9%
3/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.6%
2/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Nervous system disorders
Dizziness
|
3.9%
3/77 • 6 months.
|
7.9%
3/38 • 6 months.
|
|
Nervous system disorders
Migraine
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/77 • 6 months.
|
5.3%
2/38 • 6 months.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Psychiatric disorders
Anxiety
|
2.6%
2/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Psychiatric disorders
Abnormal dreams
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Psychiatric disorders
Agitation
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Psychiatric disorders
Delirium
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Psychiatric disorders
Depression
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Psychiatric disorders
Hallucination, visual
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Renal and urinary disorders
Urinary hesitation
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
2/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary amyloidosis
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Vascular disorders
Hypertension
|
1.3%
1/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
|
Vascular disorders
Orthostatic hypotension
|
1.3%
1/77 • 6 months.
|
0.00%
0/38 • 6 months.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/77 • 6 months.
|
2.6%
1/38 • 6 months.
|
Additional Information
SVP, Global Regulatory Affairs, Quality, and Safety
Blade Therapeutics
Phone: (650) 278 4291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place