Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) has announced that its Phase 3 RELIEF study of TNX-102 SL met its primary endpoint. TNX-102 SL effectively reduced daily pain in fibromyalgia patients compared to placebo. The company is developing TNX-102 SL as a novel, centrally-acting analgesic, non-opioid, taken once a day at bedtime to manage fibromyalgia.
TNX-102 SL met the primary endpoint of daily pain reduction in fibromyalgia patients
The RELIEF study was a 14-week double-blind, placebo-controlled, randomized, TNX-102 SL 5.6 mg trial conducted on 503 fibromyalgia patients randomized 1:1 in 39 US states. The study subjects received a single TNX-102 SL (2.8 mg) tablet or placebo in the first two weeks before expansion to two TNX-102 SL (5.6 mg) tablets or placebo for the remaining weeks.
Seth Lederman, the company’s CEO and President said that Tonix is committed to improving the lives of millions of fibromyalgia patients, of which 90% are women. He said that the RELIEF study results bring massive hope for the population. Lederman said that TNX-102 SL demonstrated clinically meaningful and statistically significant improvement on the pre-specified primary endpoint of daily pain reduction and showed activity in secondary endpoints of boosting sleep and fatigue reductions.
According to Lederman, the biggest challenge drug development is finding doses balancing tolerability and efficacy. He explained that they are delighted with the TNX-102 SL 5.6 mg’s consistent effects on the primary endpoint of reducing daily pain and tolerability of the dose in the RELIEF trial.
Tonix enrolling in phase 3 study
The CEO added that they are looking forward to the results of the currently enrolling Phase 3 study, RALLY, with the company expecting to report topline results in H2 2021. Based on the company’s mature stage of its Good Manufacturing Practice manufacturing processes, long-term safety exposure of the data already collected, and established product stability, the company anticipates filing an NDA for TNX-102 SL for fibromyalgia to the FDA by 2022 based on RALLY study results. Lederman said that they believe the company’s commercial manufacturing is on track for US market supply by 2022.