New phase 3 data found that 50 mg and 15 mg of briraloxazine significantly reduced symptoms of acute schizophrenia.1, 2
Researchers are already conducting Phase 1 trials in healthy volunteers and patients with stable schizophrenia. A phase 2 study evaluated the efficacy and safety of briraloxazine in acute schizophrenia or schizoaffective disorder.
Most recently, a team led by Laxminarayan Bhat at Reviva Pharmaceuticals conducted the pivotal Phase 3 RECOVER trial to assess safety and efficacy. RECOVER was a randomized, double-blind, placebo-controlled, multicenter study evaluating briraloxazine for 28 days in patients with acute schizophrenia. The primary endpoint is PANSS score vs. placebo from baseline to day 28, and secondary endpoints are positive and negative symptoms, PANSS social cognition, agitation/arousal, personal and social performance, clinical overall. Impressions were of severity, safety, and emergent adverse events. .
Participants were considered to have acute schizophrenia if their mean baseline positive and negative rating scale (PANSS) score was 98.22. They were randomly assigned to receive either 15 mg (n = 140), 50 mg (n = 134), or placebo (n = 137).
Researchers found that briraloxazine 50 mg achieved a 10.1 point reduction compared to placebo (-23.9 vs. -13.8; P < .001). and significantly greater positive (P < .001), negative (P = .003), negative Murder symptoms (P = .002), PANSS social cognition (P < .001), and agitation/arousal (P < .001). A significant decrease was also observed. ), PSP (P < .001), and CGI-S (P < .001). In addition, briraloxazine 15 mg was superior to placebo in all endpoints, significant in social cognition (P = 0.024) and PSP (P = 0.022).
Briraloxazine is a serotonin-dopamine signaling agent that targets D2/3/4 and 5-HT1A/2A receptors as a partial agonist and 5-HT2B/7 receptors as an antagonist. This drug helps control the inflammatory cytokines that cause the disease.
“I support brain treatments other than receptor blockade. Neuroinflammation and the areas of damage caused by inflammatory stress processes are actually gaining support for Parkinson's disease, depression, and Alzheimer's disease. and serotonin appears to modulate anti-inflammatory processes,'' Larry Ereshewski, Ph.D., owner and chief scientific officer of CenExcel Research, said in an interview. HCP live. “So this is probably another gear in this drug.” [that] Now I need confirmation. ”
Ereshevsky said. HCP Live The U.S. Food and Drug Administration wants to know the lowest effective dose, so the next step in the research is to test a 30 mg dose of briraloxazine for acute schizophrenia.
“It’s probably 3 p.m. [mg] “It works very well in stable patients, but for patients with mild symptoms, it may be a maintenance dose that is currently proven to be effective,” Ereshevsky said. “But in cases of acute psychosis, where you are trying to control someone who is a danger to themselves or others, you need higher doses of the drug than have been shown elsewhere.”
References
- Bhat, L., Bhat, S., Ramakrishnan, A. Efficacy and safety of briraloxazine in the phase 3 RECOVER trial in acute schizophrenia. His ASCPT Annual Conference to be held March 27-29, 2024 in Colorado Springs, USA.
- Reviva will present RECOVER Phase 3 clinical trial data for briraloxazine in schizophrenia at the SIRS 2024 Annual Meeting. March 28, 2024. https://revivapharma.com/reviva-to-present-recover-phase-3-clinical-trial-data-for-brilaroxazine-in-schizophrenia-at-the-sirs-2024-annual-meeting/. Accessed April 23, 2024.