Candidate: TNX-102 SL
Type: Sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
As a multifunctional agent with potent binding and antagonist activities at the serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is also in clinical development as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer’s disease.
2021 Status: Tonix said August 24 it planned to submit an IND in the fourth quarter of 2021 for a Phase II pivotal study assessing TNX-102 SL as a potential treatment for Long COVID Syndrome in patients whose symptoms (pain, sleep disturbance, fatigue and brain fog) overlap with those of fibromyalgia—for which TNX-102 SL is in mid-Phase III development. Tonix said its plans followed a Type B pre-IND meeting with the FDA, from which it has received official minutes.
On June 21, Tonix announced plans to develop TNX-102 SL as a potential treatment for Long COVID, which is also called Post-Acute Sequelae of COVID-19 (PASC).
TNX-102 SL is in mid-Phase III development for the treatment of fibromyalgia, for which interim analysis results of the second potential pivotal study are expected in the third quarter of 2021, and topline results are expected in the first quarter of 2022.
“The program leverages what we have learned about the pharmacodynamic activity of TNX-102 SL from more than one thousand participants who have been or are enrolled in our fibromyalgia trials to date,” said Tonix president and CEO Seth Lederman, MD. “Long COVID has been compared to fibromyalgia because of the common symptoms of sleep disturbance, persistent pain, fatigue, and brain fog. Additionally, Long COVID, like fibromyalgia, is experienced by women at a rate approximately four times that of men.”
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: