Promising results from the Phase 2 study of novel extended-release ketamine tablets (R-107) for Treatment-Resistant Depression accepted for publication by Nature Medicine

24.06.24 21:41 Uhr

AUCKLAND, New Zealand, June 24, 2024 /PRNewswire/ -- Douglas Pharmaceuticals, New Zealand's largest pharmaceutical company, is pleased to announce that results from their recent trial, "Randomised Placebo-Controlled Phase 2 Study of Extended-Release Ketamine Tablets (R-107) for Treatment-Resistant Depression", also known as the BEDROC study, have just been published by the leading scientific journal Nature Medicine. 

Douglas Pharmaceuticals Ltd

Douglas Pharmaceuticals' Chief Scientific Officer, Dr Peter Surman, commented, "We're pleased that the quality and design of the study, as well as the significance of the findings have been recognised and are now being shared with industry peers. Should R-107 perform in Phase 3 studies as in the BEDROC study this would be a life-changing medication for many individuals who suffer from Treatment-Resistant Depression (TRD), and one that could be taken safely at-home."

The BEDROC study enrolled patients with TRD who had failed two or more antidepressants in the current period of depression. Patients responded rapidly to R-107 during the daily dose induction phase of BEDROC and around 73% (168/231) of patients were responders after 1 week. This response rate is comparable to results achieved with off-label IV ketamine treated TRD patients but without undesirable dissociation (spacing out). R-107 shows promise to be a rapid acting, convenient and accessible form of ketamine.

Dr Surman acknowledged the valuable contributions made by Douglas' Product Development Team, the investigators involved, and Professor Paul Glue, MD, University of Otago, Hazel Buckland Professor, Chair of the Trial Steering Committee for BEDROC. Professor Glue has worked closely with Douglas as a consultant and serves as the Clinical Advisory Board Chair for R-107. With over 20 years of pharmaceutical experience, Professor Glue specialises in mood disorder research, including the use of ketamine for TRD.

Professor Glue commented, "The BEDROC study shows that it is possible to achieve a robust anti-depressant response from ketamine without significant dissociation. We saw a clear dose response effect over 3 months and met the primary efficacy endpoint at Day 92 with significant separation from placebo in the 180 mg dose arm. This gives us confidence to proceed to pivotal registrational clinical studies."

The results of the BEDROC study revealed that R-107 was well tolerated, and this was confirmed by the follow-up 6 months open-label study BEDROC-1. Most adverse events (AEs) were mild with no safety signals encountered. Dissociation and sedation AEs when administering ketamine or esketamine (one of the active components of ketamine) from rapid releasing dosage forms such as intranasal esketamine (56, 84 mg) are so significant that the product must be administered in a clinic with an observation period of at least 90 minutes after dosing. In the BEDROC study, dissociation and sedation AEs were mild and patients took R-107 at home without any safety issues.

Upon completing up to 9 months of treatment on R-107 in BEDROC and BEDROC-1 a significant portion of patients (106) were enrolled in a compassionate use program where the mean duration of treatment is currently 2 years. Most patients have continued to be treated with 180 mg of R-107 twice a week.

The peer-reviewed full manuscript can be accessed here: https://www.nature.com/articles/s41591-024-03063-x

For further information, please contact:
Lisa Craigie
Chief Legal & Commercial Officer
Douglas Pharmaceuticals
Email: lisac@douglas.co.nz 

About Treatment Resistant Depression

About 60 million patients in the United States and Europe suffer from Major Depressive Disorder (MDD).  Roughly one third of MDD patients are classified as being treatment resistant, in that they have failed two or more antidepressants in the current period of depression.  

About R-107

R-107 is a proprietary, extended-release oral dose of ketamine developed for the treatment of patients with TRD.  After administration the active ingredient ketamine is released at a slow, steady rate. The reduction in dissociative side effects is attributed to a low systemic concentration of ketamine. An IND is open with the US FDA for all studies needed to support a regulatory submission. Douglas is open to meeting potential partners and investors interested in collaborating to complete the Phase 3 development of R-107 and prepare it for commercialisation.

For more information, please visit: A world-first at home treatment for Treatment Resistant Depression - R-107 on Vimeo

About Douglas Pharmaceuticals

Douglas Pharmaceuticals is a privately held pharmaceutical company headquartered in Auckland, New Zealand.  Douglas Pharmaceuticals is a developer and manufacturer of generic and repurposed medicines sold in the US, Europe and in over 40 markets globally. The Douglas mission is to 'Improve Lives' by providing innovative, competitive, and high-quality healthcare solutions. Douglas' core business is producing prescription drugs for areas including oncology, dermatology, the central nervous system, and immunology. Douglas develops, manufactures, and distributes novel and generic products, with a preference for those where there is a strong intellectual property position as well as technical complexity in areas of high unmet need. 

For more information, please visit: www.douglas.co.nz

About Nature Medicine

Nature Medicine is a world-leading, peer-reviewed scientific journal that covers all aspects of research related to medicine. The journal has a 2022 2-year impact factor of 82.9.

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SOURCE Douglas Pharmaceuticals Ltd