Denovo Biopharma Announces Partnership with Orygen on Phase 2 Study Evaluating DB103 (Pomaglumetad Methionil) in Treating Psychosis

SAN DIEGO, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative drugs, today announced a partnership with Orygen to initiate a Phase 2 investigator-initiated-trial (IIT) to study DB103 (pomaglumetad methionil) for first-episode psychosis (FEP) or clinical high risk (CHR) of psychosis. The study is being led by Professor Patrick McGorry, M.D., and sponsored by Orygen in Parkville, Australia.

“Despite the introduction of antipsychotic medications over a decade ago, treatment options for a substantial minority of young patients with FEP or CHR of psychosis remain limited,” said Patrick McGorry, M.D., lead study investigator. “As a novel drug targeting the glutamate system, which plays a critical role in psychotic disorder, pomaglumetad presents an option to fulfill this unmet medical need. Given its excellent safety profile, it may be uniquely effective by addressing the shortcomings of other antipsychotics such as weight gain and prolactin elevation.”

“Although pomaglumetad did not achieve statistically significant efficacy in a broad schizophrenia patient study, a subset of patients early in disease exhibited significantly greater improvement,” said Wen Luo, Ph.D., Denovo's Chief Executive Officer. “The study of pomaglumetad in patients with psychosis marks an important step forward in our mission to develop innovative and transformative therapies for psychiatric conditions. We are honored to work with the world-renowned team at Orygen, internationally recognized for its scientific leadership and extensive expertise in youth mental health research.”

This open-label, Phase 2, feasibility trial will investigate the safety, tolerability, and acceptability of administering 2 daily doses of 40 mg of pomaglumetad methionil, over the duration of 12 weeks in young people aged 18-25 years with insufficient response to a single first-line antipsychotic treatment in FEP patients or failure of remission of CHR-positive symptoms and functional recovery in CHR patients. The study will also determine whether pomaglumetad can reduce total symptomatology and dysfunction. The study has been approved by the Royal Melbourne Hospital Human Research Ethics Committee (Project 2024.289).

About DB103 (pomaglumetad methionil)

Pomaglumetad methionil is a first-in-class psychiatric drug that selectively acts on the glutamic acid mGlu2/3 receptor and has no cross-reaction with other receptors in the central nervous system, and hence, can avoid some usual side effects of psychiatric drugs currently on the market. It was licensed from Eli Lilly (LLY), who had completed 37 clinical trials with more than 3,800 subjects. Pomaglumetad methionil has shown significant promise when applied to the right subpopulation of patients through personalized medicine or targeted therapy.

About Denovo Biopharma

Denovo Biopharma LLC is a clinical-stage biopharmaceutical company that uses novel biomarker approaches to execute efficient clinical trials in targeted patient subpopulations to increase the probability of success. Denovo has seven late-stage drugs in its pipeline addressing major unmet medical needs in central nervous system diseases and oncology, most of which are first-in-class drugs with global rights. A positive pivotal study of DB104 (liafensine) in patients with treatment-resistant depression who carry a Denovo-discovered novel ANK3 biomarker was recently published in JAMA Psychiatry. Visit www.denovobiopharma.com for additional information.

Investor Contact:
Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com

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