Trial Outcomes & Findings for ANC-501 in the Treatment of Adults With Major Depressive Disorder (NCT NCT05439603)

NCT ID: NCT05439603

Last Updated: 2024-12-31

Results Overview

The MADRS was utilized as the primary efficacy assessment of the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline (Day 1) to Day 56
• Results posted on: 2024-12-31

Participant Flow

This trial was conducted in 15 participants at 8 sites in the United States; 5 of the 8 trial sites enrolled subjects.

The total duration of participation is 20 weeks (up to 30 days screening, 8 weeks dosing, 8 weeks follow-up).

Participant milestones

Measure	ANC-501 Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	ANC-501 Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Overall Study met withdrawal criteria	2

Baseline Characteristics

ANC-501 in the Treatment of Adults With Major Depressive Disorder

Baseline characteristics by cohort

Measure	ANC-501 n=15 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Age, Continuous	46.4 years STANDARD_DEVIATION 13.25 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Height	164.8 cm STANDARD_DEVIATION 7.87 • n=5 Participants
Baseline Weight	82.2 kg STANDARD_DEVIATION 15.64 • n=5 Participants
BMI	30.2 kg/m^2 STANDARD_DEVIATION 4.89 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 56

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

The MADRS was utilized as the primary efficacy assessment of the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.	-17.5 score on a scale Standard Deviation 10.09

SECONDARY outcome

Timeframe: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

The MADRS was utilized to assess the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Day 8	-11.9 score on a scale Standard Deviation 12.30
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Day 15	-15.6 score on a scale Standard Deviation 11.69
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Day 29	-18.6 score on a scale Standard Deviation 10.55
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Day 43	-17.8 score on a scale Standard Deviation 10.72
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Day 56	-17.5 score on a scale Standard Deviation 10.09
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Day 70/FU	-18.8 score on a scale Standard Deviation 11.97

SECONDARY outcome

Timeframe: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

MADRS responder rate was defined as >=50% reduction in total score from Baseline (Day 1) to all time points. The MADRS consists of 10 questions, each rated on a 7-point scale, to stratify severity of depressive episodes. The MADRS total score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Day 8	6 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Day 15	6 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Day 29	8 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Day 43	9 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Day 56	7 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Day 70/FU	7 Participants

SECONDARY outcome

Timeframe: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

MADRS remission rate was defined where total score was <=10 at all time points. The MADRS consists of 10 questions, each rated on a 7-point scale, to stratify severity of depressive episodes. The MADRS total score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Day 8	2 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Day 15	3 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Day 29	4 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Day 43	3 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Day 56	2 Participants
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Day 70/FU	4 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 56

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

The HAM-A was utilized as an assessment to rate participants level of anxiety. HAM-A is a 14-item questionnaire with each question rated on a 5-point scale with a total score of 0 to 56. The higher scores indicating more severe anxiety symptoms.

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score.	-7.6 score on a scale Standard Deviation 4.86

SECONDARY outcome

Timeframe: Baseline (Day1) to Day 56

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

The CGI-S was utilized as an assessment for clinician to rate the severity of the patient's illness at the time of the assessment, relative to past experience with patients having the same diagnosis. CGI-S is a 7-point scale with response choices included: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The response at Day 56 was compared with the participants condition at Baseline prior to the first dose of study medication.

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56.	-2.3 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

The CGI-I was utilized as an assessment for clinician to rate the improvement of the patient's illness at the time of the assessment compared to patient's condition at admission of the trial. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at admission to the project, how much has he/she changed?" This question is rated on a scale from 0 to 7, where a higher score indicates greater lack of improvement. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given visit was compared with the participants condition at Baseline prior to the first dose of study medication. A CGI-I improver was defined as a subject with a CGI-I score of "Very much approved" or "Much Approved".

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Day 8	6 Participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Day 15	8 Participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Day 29	10 Participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Day 43	9 Participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Day 56	9 Participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Day 70	9 Participants

SECONDARY outcome

Timeframe: Baseline (Day1) to Day 56

Population: Efficacy population (N=13) consists of all subjects who received at least one dose of ANC501 and had completed treatment.

The CGI-I was utilized as an assessment for clinician to rate the improvement of the patient's illness at the time of the assessment compared to patient's condition at admission of the trial. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at admission to the project, how much has he/she changed?" This question is rated on a scale from 0 to 7, where a higher score indicates greater lack of improvement. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a Day 56 was compared with the participants condition at Baseline prior to the first dose of study medication. A CGI-I improver was defined as a subject with a CGI-I score of "Very much approved" or "Much Approved".

Outcome measures

Measure	ANC-501 n=13 Participants Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement	9 Participants

Adverse Events

ANC-501

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ANC-501 n=15 participants at risk Participants were administered 50 mg ANC501 (5 x 10 mg) capsules orally once daily for 8 weeks in addition to their current stable dose antidepressant therapy (ADT).
Ear and labyrinth disorders Tinnitus	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Endocrine disorders Elevated Amylase	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Endocrine disorders Elevated Lipase	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Eye disorders Bilateral Eye Disorder	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Eye disorders Blepharospasm	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Eye disorders Change in Cortical assessment per LOCS III >=0.5 in either eye compared to screening	20.0% 3/15 • Number of events 3 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Eye disorders Change in Nuclear Opalescence per LOCS III >= 0.5 in either eye as compared to screening	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Eye disorders Right Eye Disorder	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Abdominal Pain	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Diarrhea	20.0% 3/15 • Number of events 3 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Dry Mouth	13.3% 2/15 • Number of events 2 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Emesis	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Flatulence	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Gastrointestinal disorders Nausea	20.0% 3/15 • Number of events 4 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Immune system disorders Seasonal Allergies	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Infections and infestations Brown Vaginal Discharge	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Infections and infestations UTI	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Injury, poisoning and procedural complications Back strain	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Injury, poisoning and procedural complications Fall	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Injury, poisoning and procedural complications Fracture Left Ankle	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Musculoskeletal and connective tissue disorders Pain Left Ankle	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Nervous system disorders Dizziness	20.0% 3/15 • Number of events 3 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Renal and urinary disorders Burning While Urinating	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Renal and urinary disorders Increase Urinary Frequency	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Respiratory, thoracic and mediastinal disorders Chest Congestion	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.
Respiratory, thoracic and mediastinal disorders Sneeze	6.7% 1/15 • Number of events 1 • Adverse events were reported from the signing of the informed consent until the last dose of ANC-501 with a safety follow-up of 8 weeks (+-3 days). One participant out of the 15 enrolled participants had one baseline AE that began prior to study drug dosing and continued during the study.

Additional Information

Chief Medical Officer

Ancora Bio, Inc dba EmbarkNeuro

Phone: 610 871-4891

Email: info@embarkneuro.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place