HMNC Brain Health begins Phase 2 Study for personalized treatment of Stress-Axis related Major depressive Disorder (MDD)

The Company’s Nelivabon Program Pairs Novel Compound with Companion Diagnostics to Treat MDD patients

Munich, June 20, 2023 – 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.’’

If the Nelivabon program receives clinical validation, it could represent a significant advancement in the treatment of stress-axis-related MDD, a potential breakthrough in mental health treatment, supporting HMNC Brain Health’s commitment to innovation. The initial results of the Olive trial are expected in H2 2024.

About HMNC Brain Health

HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to higher remission rates. The Company develops a unique pipeline for targeting both Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The Company has presence in both the Germany and the US and is backed by a renowned global VC, several family offices, and a strategic healthcare investor. The Company now enters the next stage of its development with a large-scale licensing and fundraising agenda.

About the Nelivabon Program

The Nelivabon program is focused on developing BH-200, a vasopressin V1b receptor antagonist, to treat Major Depressive Disorder (MDD) related to dysfunction in the human body's stress system, called HPAaxis (Hypothalamus‐pituitary‐adrenal axis). BH-200 targets the elevated activity of vasopressin in the brain caused by repeated stressors, potentially reducing anxiety and depressive symptoms. The neuropeptide vasopressin coordinates hormonal and behavioral adaptation to stress, but repeated stressors can cause an overactive vasopressin system that leads to an increase in anxiety and the development of depressive symptoms. To identify depressed patients with underlying dysfunction of the HPA-axis, who may benefit from treatment with BH-200, the program includes a matching molecular diagnostic test. While the diagnostic test is still in early development, data stemming from this trial is expected to significantly improve its accuracy. BH-200 has shown to be well-tolerated in clinical trials. The program is entering a Phase-II proof-of-concept study in H1 2023 and once clinically validated, could represent an efficient treatment option for patients suffering from stress-axis-related MDD.

Media contacts (U.S.):

Anne Donohoe

Investor Contact (U.S.)

Sophia Bashford
+1 347-487-6788