HMNC Brain Health and Develco Pharma Announce Last Patient Being Randomized in Oral Prolonged-Release Ketamine (KET01) Trial for Treatment-Resistant Depression

KET01 Phase 2 Clinical Trial with Topline Results Expected Mid-Year

MUNICH, Germany, March 28, 2023 (GLOBE NEWSWIRE) -- HMNC Brain Health (“HMNC'' or the “Company”), a global clinical stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, together with Develco Pharma, announced today that the last patient has been randomized in its proof-of-concept Phase II clinical trial of ‘Ketabon’ (KET01), an oral prolonged-release ketamine formulation (KET01) for Treatment-Resistant Depression (TRD). Topline data from the Phase 2 trial, which is investigating efficacy, safety, and tolerability, is expected to be reported soon after the last study visit.

Enrollment in the Phase 2 trial commenced in June 2022 and 122 patients with treatment-resistant depression (TRD) have now been randomized at 29 clinical sites. Patients were selected based on current major depressive episodes not responding to a minimum of two standard antidepressants. The trial design enables the assessment of the oral prolonged-release formulation of ketamine that could sustainably transform the therapy of treatment-resistant depression, compared with the currently applied intravenous and intranasal ketamine and esketamine therapies.

“The goal with KET01 is to improve the lives of patients who are not responding to standard antidepressant therapies, as well as to provide a well-tolerated antidepressant with substantially limited dissociative side effects,” said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health. “We are very pleased that Ketabon is progressing positively along the pathway of approval and commercialization. The encouraging results we saw in a small Phase 2, proof-of-concept study, reported in 2022, highlighted the excellent tolerability of Ketabon, in combination with a numerically large improvement for patients treated with 240 mg/day Ketabon, and we look forward to receiving the results from our Phase 2 trial.”

Participants with TRD in the Phase 2 trial were randomized into three treatment groups and received a placebo, 120 mg/day KET01, or 240 mg/day KET01, given once daily (OD), in addition to their ongoing standard antidepressant treatment over a three-week period. The medication was taken at home. The primary endpoint was the change on the established Montgomery–Åsberg Depression Rating Scale (MADRS) score for depressive severity at day 21 compared to the placebo. Data from the previous Phase 2 trial suggested early-onset of efficacy, placebo-level dissociative side effects, and excellent tolerability, furthering the take-at-home potential of this novel treatment.

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 both in the US and Germany 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 Develco Pharma

With headquarters in Pratteln/ Switzerland, Develco Pharma is a Swiss-German pharmaceutical company specializing in the development and manufacture of orally administered modified, prolonged & chrono-release drugs containing known active ingredients. Established in 2006, today the company has a workforce of 130 employees. In Germany, a state-of-the-art production facility for analgesics & other indications has been in operation in Schopfheim, in the Baden region, since 2016. Develco identifies and defines pharmaceutical products containing known active ingredients and develops generic, hybrid, value-added, and innovative formulations backed by clinical data for the delayed or modified release of active ingredients. On the strength of its experience and innovativeness, the company has emerged as an internationally recognized provider of pharmaceuticals for the treatment of several disease areas. The customer base of Develco Pharma includes global pharmaceutical groups. The company has some 180 market approvals in all (products of different dosages) in Europe, the US, Middle East, South Africa, Asia, and Australia.

About The Ketabon Program

The Ketabon program, a joint venture between HMNC Brain Health and Develco Pharma in Switzerland comprises an oral prolonged-release formulation of ketamine for TRD with minimal dissociative side effects. The pharmacokinetic profile of the prolonged-release formulation could significantly improve the risk profile and patient convenience, by minimizing dissociative side effects compared to the currently applied intravenous and intranasal ketamine therapies. TRD patients with insufficient response to standard antidepressants represent 30% of an overall estimated number of 320 million patients worldwide suffering from major depressive disorder. Clinical development of oral prolonged-release ketamine could also be potentially expanded into other indications beyond depression, such as anxiety, aggression, PTSD, and panic disorder.