Tonix Pharmaceuticals has experienced a setback in its pipeline as it discontinues the development of a major depression disorder (MDD) therapy due to unsatisfactory results in a phase 2 trial. The trial involved 132 adults diagnosed with MDD who received a daily 39.4 mg dose of tianeptine hemioxalate extended-release tablets, referred to as TNX-601 ER, over a six-week period. The primary goal was to observe changes in baseline depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS), but the drug failed to demonstrate clinical or statistical significance, as announced in a recent post-market release.
In response to these efficacy results, CEO Seth Lederman, M.D., expressed the decision to discontinue the development of TNX-601 ER. Despite this setback, the company is looking ahead with optimism, focusing on two upcoming key milestones, both scheduled for next month. These milestones include the findings from a phase 2 study of TNX-1900 in chronic migraine, followed by phase 3 results for TNX-102 SL in fibromyalgia. The company aims to leverage these results for a potential FDA approval filing.
Also Read: Tonix’s Long COVID Drug Fails In Pain But Shows Promise In Fatigue
It’s worth noting that TNX-102 SL faced its own clinical challenges recently when Tonix decided to discontinue its investigation for fibromyalgia-like long COVID treatment. The drug failed to exhibit a statistically significant improvement in pain symptoms compared to a placebo in a phase 2 trial involving long COVID patients.
Despite the upcoming readouts and future prospects, Tonix’s stock witnessed a 17% decline, falling from 59 cents to 48 cents per share when the market opened today.
Discontinuing TNX-601 ER from the pipeline may help mitigate costs for the biotech company, which has faced financial constraints. Tonix’s spending in the first half of the year totaled nearly $100 million, depleting its cash reserves from around $120 million at the end of the previous year to just $25 million by June 30. To boost its finances, the company recently raised $4.5 million by selling stock at 50 cents per share.
Tonix Pharmaceuticals had previously communicated its intention to prioritize resources for its central nervous system pipeline while deprioritizing work on a COVID vaccine and other preclinical programs, aligning its focus with its strategic goals and available resources.
