FDA provides feedback supporting Hepion’s 505(b)(2) pathway and Phase‑2 design for gambling‑disorder drug GV104
Hepion Pharmaceuticals’ subsidiary Gravitas Life Sciences received written responses from the FDA’s Division of Psychiatry on its pre‑IND request for GV104, a buccal film of nalmefene intended to treat gambling disorder. The agency indicated that a 505(b)(2) New Drug Application route is appropriate and that the non‑clinical data are adequate to support a 12‑week Phase 2 study. It also judged the proposed proof‑of‑concept design and severity‑assessment endpoint to be suitable. Gravitas plans to incorporate the feedback and file a full IND in 2027.
Why it matters
The FDA’s endorsement of the regulatory pathway and study design moves the program toward an IND filing, which could eventually create the first approved pharmacotherapy for gambling disorder. Investors should watch for the IND submission timeline and any subsequent trial results that may affect Hepion’s valuation.
Key facts
- 1The FDA’s Division of Psychiatry responded to Gravitas Life Sciences’ pre‑IND meeting request for GV104. stocktitan.net
- 2The agency indicated that a 505(b)(2) New Drug Application route is appropriate for GV104. stocktitan.net
- 3Non‑clinical studies already on file are considered sufficient to support a 12‑week dosing regimen in a Phase 2 trial. stocktitan.net
- 4The FDA judged the planned Phase 2 proof‑of‑concept design and the proposed disease‑severity assessment tool to be appropriate as the primary endpoint. stocktitan.net
- 5Gravitas intends to file a full IND for GV104 in 2027. stocktitan.net
- 6Gambling disorder affects roughly 2 million U.S. adults and has no approved pharmacotherapy. investing.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.