HMNC Brain Health Expands International Patent Portfolio with Two Stress-axis Related Substances for Major Depressive Disorder

In-Licensing arrangement with the renowned Max Planck Society, extends patent protection for clinical research and strengthens Nelivabon and Cortibon developmental projects

The Company has also established an office in the United States, furthering global expansion strategy

MUNICH, Germany, Jan. 25, 2022 (GLOBE NEWSWIRE) — HMNC Brain Health, (“HMNC” or the “company”), a clinical stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, announced that it has expanded its international patent portfolio in the field of psychiatric therapy with two patent families claiming substances for treating stress-axis related Major Depressive Disorder. These license agreements are part of a broader collaboration with the renowned Max-Planck-Society, comprising biomarker patent claims and therapeutic patent claims covering markets in Europe, the U.S., and now Asia, in particular Japan.

Utilizing a more personalized approach to discovering new drugs in psychiatry, the two targeted stress hormone therapies are promising patent candidates – Corticotropin-Releasing Hormone Receptor 1 (CRHR1) antagonists and vasopressin1B – receptor (V1BR) antagonists. Because only a limited proportion of patients with stress-related depression have persistently elevated levels of CRH or vasopressin, by tailoring therapies according to an individual’s biosignature through this targeted approach, some patients could better control the triggers for the production of a stress hormone.

Benedikt von Braunmühl, CEO at HMNC Brain Health, said:
“This is yet another example of our effective scientific collaborative initiatives, based on more than 30 years of research in depression and anxiety disorders. By strengthening the strategic intellectual property protection of our assets, we are further developing our patent portfolio internationally, with newly signed licenses and the assistance of Dr. Christian Kilger, a Patent Attorney from CH KILGER in Berlin. Dr. Kilger has led numerous companies successfully through complex patent oppositions, patent litigations, and IPOs in the international biotech arena and will help us to fully realize the therapeutic and commercial potential of our compounds and develop them globally for the patients in need as well as for our investors.”

The first patent in-licenses the granted Japanese patent JP 6309511 B2, a V1b antagonist – which is being developed within the Company’s subsidiary Nelivabon Project for use in the treatment of patients showing an elevated Arginine Vasopressin (AVP) level.

The second patent family relates to the CRHR1 antagonist project for use in the treatment of patients having Corticotropin-Releasing Hormone (CRH) overactivity. EP 2 841 068 B1 was granted in 2018 and will expire in 2033. The filing of a supplementary protection certificate could further extend the patent term. The Company also currently has pending patent applications in the United States and Japan. These therapeutic patent claims stand alongside two further patent families covering CRHR1 antagonist patient response (proprietary biomarkers).

HMNC Brain Health’s Chief Clinical Development Officer, Dr. Hans Eriksson, added: “The extended patent protection supports us in pursuing highest quality clinical research as we work to transform therapy of neuropsychiatric disorders. We will put all our effort in developing these promising compounds into highly efficient medications and improve the lives of many patients suffering from Major Depressive Disorder.”

In addition, HMNC Brain Health announced that it has established an office in the United States as the next step in furthering its international expansion strategy. This follows the recent appointment of Nir Naor, who is based in the United States, as HMNC Brain Health’s new Chief Financial Officer.

“We are entering an important phase of growth for the Company and establishing a presence in the United States is a key milestone in our strategy of operational expansion and global capital markets engagement,” said Mr. von Braunmühl.

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 far shorter treatments and higher remission rates. The company develops a unique pipeline for targeting both major depressive disorder (MDD) and treatment-resistant depression (TRD). The company has operations in both the US and Germany and is backed by a renowned global venture capital firm, 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 Project
HMNC Brain Health’s Nelivabon project comprises the Phase-II-ready compound nelivaptan and a matching molecular diagnostic test targeting the 30% of Major Depressive Disorder (MDD) related to a dysfunction in the human body’s stress system (HPA-axis). 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 treat this dysfunction. The clinical development is combined with a predictive companion diagnostic, which identifies depressed patients with an underlying dysfunction of the HPA-axis. 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. The project is entering a Phase-II proof-of concept study in 2022.

About the Cortibon Project
Within the Cortibon project, HMNC Brain Health develops the compound E2009, a corticotropin-releasing hormone (CRH) receptor 1 antagonist, in-licensed from Eisai, together with a companion diagnostic. The neuropeptide corticotropin-releasing hormone coordinates hormonal and behavioral adaptation to stress. In about one third of patients with depression, CRH is believed to be involved in the development of the disorder. CRH antagonists thus have the potential to improve the depressive symptoms. So far, it has not been possible to identify the patients in which elevated CRH in the brain is the cause of depression. As a result, CRHR1 antagonists have not yet entered the market. HMNC Brain Health has developed and clinically validated a molecular laboratory test that allows to select the subset of depressed individuals with a disturbance in their stress axis system and thus indicates which patients with depression will respond well to a CRH blocker and which will not.

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

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