Cybin Inc. Reports Positive 12-Month Data for CYB003
Ticker: HELP · Form: 6-K · Filed: Nov 18, 2024 · CIK: 1833141
| Field | Detail |
|---|---|
| Company | Cybin INC. (HELP) |
| Form Type | 6-K |
| Filed Date | Nov 18, 2024 |
| Risk Level | medium |
| Pages | 2 |
| Reading Time | 2 min |
| Sentiment | bullish |
Sentiment: bullish
Topics: clinical-trial-data, drug-development, mental-health, biotech
TL;DR
Cybin's CYB003 shows sustained depression relief in 12-month study, good sign for MDD treatment.
AI Summary
On November 18, 2024, Cybin Inc. announced positive 12-month efficacy data from its Phase 2 study of CYB003, a deuterated psilocin program for major depressive disorder. Seven out of eight participants who completed the 12-month follow-up showed sustained symptom reduction.
Why It Matters
This data suggests CYB003 may offer long-term benefits for major depressive disorder patients, potentially representing a significant advancement in mental health treatment.
Risk Assessment
Risk Level: medium — The company is in clinical development for a novel drug, which carries inherent risks related to trial outcomes, regulatory approval, and market adoption.
Key Numbers
- 8 — Participants completing 12-month follow-up (Indicates high retention in the study)
- 7 — Participants showing sustained symptom reduction (Demonstrates efficacy of CYB003 over 12 months)
Key Players & Entities
- Cybin Inc. (company) — Registrant and developer of CYB003
- CYB003 (drug) — Proprietary deuterated psilocin program
- November 18, 2024 (date) — Date of announcement
- major depressive disorder (condition) — Indication for CYB003 treatment
FAQ
What specific metrics were used to measure symptom reduction in the Phase 2 study?
The filing does not specify the exact metrics used to measure symptom reduction, but it indicates sustained symptom reduction was observed.
What is the next step for CYB003 following these Phase 2 results?
The filing does not explicitly state the next steps, but positive Phase 2 data typically leads to planning for Phase 3 trials.
What is the dosage of CYB003 used in the study that yielded these results?
The results reported are for the 16 mg dosage of CYB003.
What is the primary goal of Cybin Inc.'s CYB003 program?
The primary goal is the potential adjunctive treatment of major depressive disorder.
When was this 12-month efficacy data announced?
The 12-month efficacy data was announced on November 18, 2024.
Filing Stats: 532 words · 2 min read · ~2 pages · Grade level 10.7 · Accepted 2024-11-18 07:54:31
Filing Documents
- form6k.htm (6-K) — 9KB
- exhibit99-1.htm (EX-99.1) — 19KB
- exhibit99-1x001.jpg (GRAPHIC) — 5KB
- 0001062993-24-019233.txt ( ) — 36KB
From the Filing
Cybin Inc.: Form 6-K - Filed by newsfilecorp.com UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of November, 2024 . Commission File Number: 001-40673 Cybin Inc. (Exact Name of Registrant as Specified in Charter) 100 King Street West, Suite 5600, Toronto, Ontario, M5X 1C9 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F Form 40-F INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K On November 18, 2024, Cybin Inc. (the "Company") announced 12-month efficacy data from its Phase 2 study of CYB003, a proprietary deuterated psilocin program in development for the potential adjunctive treatment of major depressive disorder). A summary of the Phase 2 study data is provided below: Summary of 12-Month Efficacy Data for CYB003 16 mg Eight participants completed the 12-month follow-up of which seven received two doses (active-active) of 16 mg and one received a single dose of 16 mg (placebo - active). Mean change from baseline in Montgomery-Asberg Depression Rating Scale ("MADRS") was 23 points after two doses of 16 mg (n=7). Mean baseline MADRS was 32 points across the 12 mg and 16 mg dosing arms. 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. The two participants in the 16 mg dosing arm that were responders (50% reduction in MADRS score) but not remitters had MADRS scores of 11; remission is defined as MADRS total score 10. Summary of 12-Month Efficacy Data for CYB003 12 mg Thirteen participants completed the 12-month follow-up of which ten received two doses (active-active) of 12 mg and three received a single dose of 12 mg (placebo - active). Mean change from baseline in MADRS was 18 points after two doses of 12 mg (n=10). 60% of participants receiving two doses of 12 mg were responders. 50% of participants receiving two doses of 12 mg were in remission. Safety and tolerability: CYB003 has demonstrated an excellent safety profile. No new adverse events were reported in the 12-month follow up, including no reports of suicidality. INCORPORATION BY REFERENCE The information contained in the section "Information Contained in this Report on Form 6-K" shall be deemed to be incorporated by reference in the Registration Statement on Form F-10 (File No. 333-276333) of the Company, as amended or supplemented, to the extent not superseded by documents or reports subsequently filed. For purposes of clarity, the press release furnished as Exhibit 99.1 of this Form 6-K of the Company is not incorporated by reference into the Registration Statement on Form F-10 (File No. 333-276333) of the Company, as amended or supplemented. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. CYBIN INC. (Registrant) Date: November 18, 2024 By: /s/ Doug Drysdale Name: Doug Drysdale Title: Chief Executive Officer EXHIBIT INDEX 99.1 News Release dated November 18, 2024