Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) revealed Friday that it had successfully completed the required fed-fasting and dose proportionality tests of its lead product candidate, Tonmya, or TNX-102 SL, in healthy volunteers to support the new drug applications for the drug in treating post-traumatic stress disorder (PTSD) and fibromyalgia.
In a statement, the New York-based clinical-stage biopharmaceutical company said the preliminary results of the study showed “no significant effect” of a fatty meal on the rate or extent of absorption of TNX-102 SL 5.6 mg administered as 2 x 2.8 mg sublingual tablets.
“The absence of a food effect is consistent with transmucosal absorption after sublingual administration,” noted the company.
Investors responded well, sending Tonix shares nearly 13% higher to $1.57 in afternoon trade.
The company’s lead product candidate, Tonmya, or TNX-102 SL, is a proprietary low-dose cyclobenzaprine, or CBP, sublingual tablet, designed for bedtime administration, and is in Phase 3 development as a treatment for PTSD and fibromyalgia, a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood swings. It is designated by the FDA as a Breakthrough Therapy.
Oral cyclobenzaprine products approved for treating muscle spasm have significant increases in absorption with food.
Food effects which change plasma drug levels can add unpredictability for patients in terms of therapeutic benefits or side effects, explained the company.
The study showed the rate and extent of absorption of cyclobenzaprine increase in a dose-proportional manner from 2.8 mg to 5.6 mg for TNX-102 SL. The dose proportionality observed in this study confirms an earlier study using a prototype 2.4 mg formulation.
The company said that the study found that lack of a food effect for TNX-102 SL supports therapeutic predictability.
Tonix is focused on discovering and developing small molecules and biologics to treat psychiatric, pain and addiction conditions. Its lead product candidate, TNX-102 SL, is in the Phase 3 RECOVERY trial for PTSD, and is currently enrolling. Results from an interim analysis for a potential sample size are expected in the first quarter of 2020 and topline data is expected in the second quarter of 2020, if the sample size remains the same.
Tonix has also started enrollment in the Phase 3 RELIEF trial in fibromyalgia. TNX-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder. The agitation in Alzheimer’s disease program is Phase 2 ready with FDA Fast Track designation.
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