– FDA’s Division of Psychiatry issued written responses to a Type B pre-IND meeting request covering the regulatory pathway, the nonclinical package, and the design of a planned Phase 2 study-
– Confirmed that the nonclinical and manufacturing data already on file under an IND may be cross-referenced to the new program, and stated that a planned Phase 2 proof-of-concept design is, in general, appropriate –
– There are no FDA-approved medications for gambling disorder; Company anticipates filing an IND for GV104 and commencing the path toward a Phase 2 study in 2027 –
RED BANK, NJ / ACCESS Newswire / October 19, 2026 / Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) (“Hepion” or the “Company”), a biotechnology company developing a portfolio of diagnostic and therapeutic candidates for serious liver, immune, and inflammatory diseases, today announced that its wholly-owned subsidiary Gravitas Life Sciences, LLC (“GLS”), a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation, has received written responses from the U.S. Food and Drug Administration (“FDA”or “Agency”) to its Type B pre-Investigational New Drug (“pre-IND”) meeting request for GV104, a transmucosal buccal film, in the treatment of gambling disorder. The responses, issued by the FDA’s Division of Psychiatry, address the regulatory pathway, the nonclinical package, the design of a planned Phase 2 study, and next steps.
Gambling disorder is a recognized psychiatric diagnosis, and it has no approved pharmacotherapy. Care today rests on counseling, peer support and other psychosocial approaches, and specialized treatment has begun to organize around the disorder: virtual programs now operate nationally, reimbursed by commercial insurers and state funding, with courses of care commonly running six to twelve months. The Company believes the FDA’s written feedback provides a defined framework for advancing GV104 toward an IND submission and the initiation of a Phase 2 study. The Company intends that it be studied as an addition to psychosocial care rather than a replacement.
Key Highlights of the FDA’s Written Responses
- Regulatory pathway. The FDA provided guidance on the requirements for a 505(b)(2) New Drug Application, under which GLS intends to rely in part on the FDA’s prior findings for an approved nalmefene product.
- Leveraging existing GV104 program. The FDA confirmed that GLS may cross-reference a previous IND for the nonclinical and chemistry, manufacturing and controls sections of the new gambling disorder program.
- Nonclinical support for a 12-week study. The FDA stated that the nonclinical studies submitted to the previous IND appear potentially sufficient to support clinical dosing of 12-week duration in a Phase 2 study.
- Phase 2 study design. The FDA stated that the planned Phase 2 proof-of-concept design is, in general, appropriate, and that the proposed disease severity assessment tool is appropriate as a primary endpoint for the planned trial.
- Phase 3 plans and the NDA. The FDA stated that the Company’s proposed plans to support clinical studies longer than 12 weeks appear reasonable, and outlined the additional nonclinical data it expects at the time of a New Drug Application.
“The Agency’s responses do two things for this program,” said Sireesh Appajosyula, PharmD, Chief Executive Officer of Hepion. “They describe a 505(b)(2) route that relies in part on the FDA’s prior findings for an approved form of the product and confirm that the nonclinical and manufacturing work already on file under another IND can be cross-referenced. This extends work the team has been building for several years. We intend to incorporate FDA recommendations, including dose-ranging and endpoint validation and we aim to keep working with the Agency at every step that follows. This program will be built with the people who understand the disorder best – the investigators and clinicians treating it now.”
“Gambling disorder is a psychiatric illness with measurable mortality, and it has no approved medicine,” said Nir Barak, MD, said Chief Medical Advisor of Gravitas Life Sciences. “Counseling and peer support carry this field today, and the clinicians who deliver them do that work without a single approved medicine to prescribe. The FDA has now described what a credible first study looks like, including that our proposed severity assessment is appropriate as the primary endpoint.”
GLS intends to design its Phase 2 protocol to reflect the FDA’s recommendations and to file a full IND for GV104 in gambling disorder, which the Company anticipates in 2027. The final design of the Phase 2 proof-of-concept trial remains subject to change as the Agency’s feedback is incorporated and following IND review. Alongside the regulatory work, the Company intends to engage the clinical and scientific expertise that has formed around this disorder – academic investigators, clinicians who treat gambling disorder day to day, and the patient and advocacy organizations closest to it – to inform protocol design, endpoint validation, and investigator and site selection, so what the study measures matters to patients and their families. The Company intends to continue working with the FDA as the program advances, through the planned meeting on chemistry, manufacturing and controls, the IND submission and the studies that follow, with the objective of bringing a first approved medicine to people living with this condition.
About GV104
GV104 is an investigational transmucosal buccal film of nalmefene, an opioid receptor modulator that acts as an antagonist at the mu and delta opioid receptors and a partial agonist at the kappa receptor; it has not been approved by the FDA or any other regulatory authority for any indication. Nalmefene was first approved in the United States in 1995 and is marketed in injectable and nasal spray formulations for opioid overdose and the reversal of opioid effects; it is not approved for the treatment of gambling disorder, and although opioid receptor modulators have been investigated in this condition by academic research groups for more than two decades, no therapy has been approved for it. Delivered across the buccal mucosa, the film potentially bypasses first-pass hepatic metabolism, and GLS holds an exclusive, sublicensable, worldwide license to the relevant patent rights and technology. GLS is also developing GV104 for temporary prophylaxis against high-potency opioid exposure in military personnel and chemical incident responders.
About Gambling Disorder
Gambling disorder is a DSM-5 non-substance-related addictive disorder: persistent, recurrent problematic gambling that causes clinically significant impairment or distress. The National Council on Problem Gambling (NCPG) estimates that about 2 million U.S. adults, roughly 1 percent, meet the criteria for a severe gambling problem, and its 2024 national survey found nearly 20 million reported at least one problematic gambling behavior “many times” in the past year. Care runs through 12-step fellowships, crisis lines and a small number of gambling-trained clinicians, and specialized virtual programs now operate in all 50 states with commercial insurance and state funding, with courses of care commonly six to twelve months – infrastructure that can diagnose, enroll and follow patients over the horizon a medicine would be prescribed across. The vast majority of people who gamble do so recreationally and without harm, but for those who meet the diagnostic criteria there is no approved medicine. Help exists today through the National Problem Gambling Helpline, operated by the NCPG, available 24 hours a day at 1-800-GAMBLER, and the 988 Suicide and Crisis Lifeline by call or text at 988.
About Hepion Pharmaceuticals:
Hepion Pharmaceuticals, Inc. (OTCQB:HEPA) is a biotechnology company developing a portfolio of diagnostic and therapeutic candidates for serious liver, immune, and inflammatory diseases. Through its subsidiary Gravitas Life Sciences, LLC, a clinical-stage biotechnology company, Hepion is advancing therapeutic candidates in immunology and inflammation, including a transmucosal buccal film of an established opioid antagonist and an oral formulation of a validated anti-inflammatory antibody. The Company's diagnostic program is built on novel circulating tumor RNA technology, which reads actively expressed tumor transcripts for the early detection of hepatocellular carcinoma in high-risk cirrhotic patients, a cancer that is curable when found early. For more information please visit: https://hepionpharma.com/.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, are forward-looking statements, including statements regarding the Company’s interpretation of the FDA’s written responses, the regulatory pathway for GV104 in gambling disorder, the Company’s intention to submit a full Investigational New Drug application and the timing of any such submission, the design, initiation, conduct and endpoints of a planned Phase 2 study, the ability to cross-reference data on file under an existing IND, plans for studies longer than 12 weeks and for a future New Drug Application, the availability of capital to fund the program, and the Company’s strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Feedback received at or in response to a pre-IND meeting request is advisory and is not binding on the FDA, and the Agency may change its views at any later stage of development. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, actual results or events could differ materially from them, and you should not place undue reliance on them. Factors that may cause such differences include, but are not limited to, those discussed under Risk Factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and other periodic reports filed with the Securities and Exchange Commission. These forward-looking statements represent the Company’s views as of the date of this release and should not be relied upon as representing its views as of any subsequent date; the Company does not undertake and specifically disclaims any obligation to update or revise them, except as may be required by applicable law.
Contacts:
Hepion Investor Relations
ir@hepionpharma.com
https://hepionpharma.com/
SOURCE: Hepion Pharmaceuticals
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