HMNC Brain Health Initiates Pioneering Precision Therapy Program in Mental Health

• Pioneering the first large-scale double-blind studies to test the combination of therapies and genetic companion diagnostics in the area of mental health
• Partners with worldwide leading contract research organization, ICON
• Program targeting the 30% of Major Depressive Disorder related to a dysfunction in the human body’s stress system with a completely novel mode of action
• First patient planned for enrollment in Q1, 2022; first results expected in Q2, 2023

MUNICH, Germany, Sept. 16, 2021 (GLOBE NEWSWIRE) — HMNC Brain Health, (“HMNC” or the “company”), a clinical stage biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, has entered a definitive agreement to initiate a clinical phase II proof-of-concept program for its Nelivabon Project, targeting the 30% of Major Depressive Disorder (MDD) related to a dysfunction in the human body’s stress system with a completely novel mode of action.

This is the first time ever that large-scale precision therapy studies are being conducted in the area of mental health. HMNC Brain Health has developed the compound BH-200, which specifically targets the dysfunction of the HPA-Axis (Hypothalamus‐pituitary‐adrenal axis), also called the stress axis in correlation with a companion biomarker test. The phase II program includes novel features as it in parallel will evaluate the test performance and the activity of BH-200 in two separate studies. A successful program would bring the total of positive trials to three and mark a huge step towards market approval. The Phase II studies will be set up and operated by ICON, one of the world’s leading contract research organizations and will start in Q1, 2022.

“Genetic tests in combination with treatment are a common protocol in other medical areas such as oncology, but it’s a novelty in psychiatry. The ability to apply this combined concept in depression therapy has the potential to be a significant breakthrough in the treatment of mental health disorders,” said Dr. Hans Eriksson, Chief Clinical Development Officer of HMNC Brain Health.

The first patient enrolled for the Nelivabon Project is expected in Q1, 2022 for the first segment of the study, with the second segment of the study slated for Q3, 2022. The initial results data will be available beginning of Q2, 2023.

“As we shift from a traditional ‘one-size-fits-all’ treatment model for mental health disorders, we are exploring more robust, and targeted therapies,” adds Benedikt von Braunmühl, Chief Executive Officer at HMNC Brain Health. “Our Nelivabon Project addresses a high unmet medical need for many patients suffering from a dysfunction in the body’s stress system. Once clinically validated in conjunction with its predictive companion diagnostic, the project will be a potential solution for millions of patients suffering from this form of MDD. We are very confident that our precision psychiatry approach for the treatment of Major Depressive Disorder will prove its noteworthy potential addressing a large patient population.”

About the Nelivabon Project

With the Nelivabon Project, HMNC Brain Health has worldwide exclusive rights to a completely novel compound addressing a high unmet medical need. The project comprises the compound BH-200 and a matching molecular diagnostic test targeting the dysfunction of the HPA-Axis (Hypothalamus‐pituitary‐adrenal axis), also called the stress axis with a completely novel mode of action. The neuropeptide vasopressin coordinates hormonal and behavioral adaptation to stress. Repeated stressors cause an elevated activity of vasopressin in the brain, potentially resulting in an increase of anxiety and a major depressive episode. BH-200 is an antagonist at the vasopressin V1b receptor, expected to be able to target this dysfunction. The clinical development is combined with a predictive companion diagnostic which identifies patients with an underlying dysfunction of the HPA-Axis -related major depressive disorder. These simple to perform molecular-diagnostic tests pave the way for the targeted use of antidepressants as they enable physicians to predict their patient’s response to special treatments. The now starting phase II program includes novel features since it in parallel will evaluate the test performance and the activity of BH-200 in two separate studies. A successful program would bring the total of positive trials to three and mark a huge step towards market approval. The compound BH-200 was in-licensed worldwide exclusively from Sanofi after having demonstrated efficacy despite being tested in an unselected population. At Sanofi, the predefined primary endpoint was met in one of the two MDD studies conducted, supporting the antidepressant efficacy of BH-200. Once clinically validated in conjunction with its predictive companion diagnostic, the Nelivabon Project could represent a highly efficient treatment for those patients suffering stress axis related MDD.

About HMNC Brain Health

HMNC Brain Health (HMNC Holding GmbH) is a clinical stage biopharma company pioneering in developing personalized therapies powered by predictive companion diagnostics, leading to far shorter treatments and higher remission. The company develops a unique pipeline for targeting both major depressive disorder (MDD) and treatment-resistant depression (TRD). HMNC Brain Health is located at one of the leading European biotech hubs in Munich and backed by renowned family offices. The company now enters the next stage of its development with a large-scale licensing and fundraising agenda.

About ICON

ICON is a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organizations.

Media Contacts
Alexander Schmidt (Europe)
+49 151 22 99 39 765
alexander.schmidt@gaulyadvisors.com

Anne Donohoe (U.S.)
+1 212-896-1265
hmnc@kcsa.com

Investor Contact (U.S.)
Tim Regan
+1 347-487-6788
tregan@kcsa.com