Neumora Therapeutics, a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, announced results from the Phase 3 KOASTAL-1 Study of navacaprant for the treatment of major depressive disorder (MDD). The KOASTAL-1 Study is the first of three replicate Phase 3 studies that comprise the pivotal KOASTAL program. The study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) scale.
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“We are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD. There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants,” said Rob Lenz, executive vice president, head of research and development, Neumora.
“We will not waver on our mission to make a difference for people living with brain diseases, which our broad pipeline of novel programs has the potential to address. The outcome of KOASTAL-1 is not what we expected, but there are encouraging trends in the data that we are analyzing,” said Henry Gosebruch, president and chief executive officer, Neumora. “Our strong financial foundation and cash balance of $342 million as of the end of the third quarter provides runway into mid-2026, and we look forward to providing additional updates on the navacaprant development program and our pipeline at the J.P. Morgan Healthcare Conference. We’d like to express our appreciation to the patients, families, and investigators who participated in this trial.”
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KOASTAL-1 Study Summary Results
The KOASTAL-1 study enrolled 383 adult patients with MDD. Topline efficacy results for navacaprant compared to placebo are outlined in the following table:
| MADRS Total Score | SHAPS Total Score | |||||
| Outcome | Navacaprant 80 mg |
Placebo | LSMD | Navacaprant 80 mg |
Placebo | LSMD |
| ITT population CFB at Week 6 (Primary Endpoint) | -12.5 (n = 191) |
-12.5 (n = 192) |
0.0 (p = 0.993) |
-5.8 (n = 191) |
-5.5 (n = 192) |
-0.3 (p = 0.648) |
| Female population CFB at Week 6 | -14.0 (n = 105) |
-11.4 (n = 106) |
-2.7 (p = 0.072) |
-7.2 (n = 105) |
-4.9 (n = 106) |
-2.3 (p = 0.015) |
| Male population CFB at Week 6 | -10.6 (n = 86) |
-13.8 (n = 86) |
3.2 — |
-4.3 (n = 86) |
-6.3 (n = 86) |
2.0 — |
CFB = change from baseline; LSMD = difference in LS mean change from baseline between navacaprant and placebo groups generated from mixed-effects model for repeated measures. Subgroup analysis for male or female are pre-specified.
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Navacaprant was shown to be safe and generally well-tolerated with no serious adverse events reported. There was no signal for increased suicidal ideation or suicidal behavior compared to placebo, as measured by Columbia Suicide Severity Rating Scale (C-SSRS).
| Treatment Emergent Adverse Events (TEAEs) in Either Treatment Group (≥5%) | Navacaprant 80 mg (n = 191) | Placebo (n = 192) |
| Headache | 13 (6.8%) | 14 (7.3%) |
| Diarrhea | 10 (5.2%) | 4 (2.1%) |
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- Other notable TEAEs included pruritus (navacaprant 80 mg: 7 (3.7%), placebo: 4 (2.1%)).
- Rates of treatment discontinuation due to TEAEs were low (navacaprant 80 mg: 2.1%, placebo: 3.1%).
- A significant proportion (83.3%) of navacaprant 80 mg-treated patients who completed 6 weeks’ treatment elected to enroll in KOASTAL-LT.
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Source – globenewswire
