Trial data suggests major breakthrough in Treatment Resistant Depression
15 June 2021
New Zealand based Douglas Pharmaceuticals Ltd is pleased to announce that a majority of patients with Treatment Resistant Depression experienced rapid relief of their symptoms when treated with R-107 (extended-release oral dose of ketamine) in a Phase 2 study.
The study, R107-C205 (BEDROC), enrolled 234 subjects diagnosed with Treatment Resistant Depression with a mean baseline score of 31 on the Montgomery-Åsberg Depression Rating Scale (MADRS) who had failed to respond to at least two anti-depressants. At the enrichment phase, all patients were dosed with R-107 daily for 5 days and on Day 8 were reassessed, by which time the mean MADRS score had dropped from 31 to 13 with 169 (72%) of the subjects being classified as treatment responders (with a MADRS score ≤12).
Responders to the enrichment week then entered a double-blinded, randomised and placebo-controlled dose-finding study of 12 weeks duration where they receive R-107 or placebo twice a week.
Top-line safety and efficacy results from this study are expected in November 2021 by which time Douglas Pharmaceuticals intends to commence commercial partnering for NDA (new drug application) enabling Phase 3 trials.
Subjects who complete BEDROC are eligible to enter an open label trial (R107-C206, BEDROC-1) where they are treated with R-107 twice weekly for 6 months. Of the 114 subjects so far treated 50 are in remission (MADRS ≤ 10), 96 of subjects have MADRS < 22, while 18 subjects remain severely depressed with MADRS ≥ 22.
Douglas Pharmaceuticals Ltd Chief Scientific Officer, Dr Peter Surman, says “The data from the enrichment phase demonstrates a significant and rapid treatment effect and a well-tolerated safety profile in patients with Treatment Resistant Depression.”
He says many patients who complete BEDROC-1 have requested compassionate supply from their primary care physician. Based on the current trend he expects a significant number of those patients randomised in BEDROC will enrol in the compassionate use program following BEDROC-1.
With trial recruitment now complete, Managing Director of Douglas Pharmaceuticals Ltd, Jeff Douglas, says “Clinically meaningful efficacy as an anti-depressant could make R107 an ideal therapy for people who suffer with major depression. The rapid on-set of remission, usually within one to two days of starting therapy, if confirmed, is a major medical breakthrough compared to current oral treatments where patients can take four to six weeks to see a significant improvement in mood.”
Professor Paul Glue, MD, University of Otago and National Lead Investigator for BEDROC, BEDROC-1 says “As a researcher, a psychiatrist and clinician who treats many patients with Treatment Resistant Depression, I am really encouraged by this data.” Professor Glue adds “The rapid on-set of treatment response with R107 is particularly impressive and, if confirmed, will have a significant impact on the treatment of patients with major depressive disorder as well as those with increased risk of suicidality.”
This press release is intended to communicate the scientific outcomes of the Phase 2 trial of R-107. R-107 is an investigational new drug and is not available for commercial distribution. The outcomes of the Phase 2 study will have to be confirmed by an additional pivotal Phase 3 study and subsequent registration of the product before any definitive conclusions or claims regarding the safety and effectiveness of R-107 can be made.