The Company’s Nelivabon Program Pairs Novel Compound with Companion Diagnostics to Treat MDD patients
MUNICH, Germany, June 20, 2023 (GLOBE NEWSWIRE) -- HMNC Brain Health (‘‘HMNC’’ or the ‘‘Company’’), a global clinical-stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, announced today that the first patient has been enrolled in the Olive trial, a randomized, double-blind, placebo-controlled trial in more than 300 patients with Major Depressive Disorder (MDD) conducted in eight countries in Europe.
The Olive trial is a crucial component of the Nelivabon program, aimed at developing BH-200, a potent vasopressin V1b receptor antagonist, for improved treatment of patients with MDD who have underlying HPA-axis (Hypothalamus‐pituitary‐adrenal axis) dysfunction. The neuropeptide vasopressin plays a critical role in coordinating hormonal and behavioral adaptation to stress, and its elevated activity in the brain following repeated stressors may increase anxiety and depressive symptoms. BH-200 directly targets the HPA-axis dysfunction and has demonstrated promising tolerability in previous clinical trials.
The Olive trial will evaluate the efficacy and safety of BH-200 in depressed patients. Moreover, it will test the predictive capabilities of the V1b polygenic score, which the company aims to eventually develop into a companion diagnostic for BH-200. As this genetic in-vitro diagnostic test is still under development, the Olive trial will recruit every patient regardless of genetic status, and a post-hoc analysis will be performed. The hypothesis is that patients with a high V1b polygenic score, which is estimated to be around 30% of the population, will benefit the most from BH-200.
‘‘The initiation of the Olive trial for the Nelivabon program marks an important milestone in our pursuit of providing innovative and personalized treatments for patients suffering from stress-axis-related MDD,’’ said Dr. Maximilian Doebler, Chief Business Officer of HMNC Brain Health. ‘‘We remain committed to advancing our clinical research pipeline to address unmet needs in mental health care and ultimately bring new treatment options to patients suffering from mental health disorders such as MDD.’’
‘‘The development of the predictive companion diagnostic as part of the Nelivabon program reflects HMNC Brain Health's focus on targeted and personalized treatments. By identifying patients with a specific dysfunction of the HPA-axis, the program aims to provide tailored and efficient treatment options, furthering the company's goal of delivering personalized healthcare solutions,’’ said Dr. Hans Eriksson, Chief Medical Officer of HMNC Brain Health. ‘‘The commencement of our Phase 2 study is a crucial step in validating the safety and efficacy of this innovative treatment strategy. We are very confident that our precision psychiatry approach for the treatment of MDD will prove its noteworthy potential addressing a large patient population.’’