Trial Data Suggests Major Breakthrough In Treatment Resistant Depression
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.”