Tonix Pharmaceuticals’ Investigational New Drug (IND) application for starting a Phase II clinical trial of TNX-102 SL for Long Covid-19 was granted clearance by the US Food and Drug Administration (FDA).
The randomised, double-blind, placebo-controlled Phase II trial of TNX-102 is anticipated to commence in the second quarter of this year.
It will assess the safety and efficacy of a 5.6mg daily sublingual dose of TNX-102 to treat Long Covid patients having pain at various sites.
To be carried out at nearly 30 clinical centres, the trial will enrol around 470 patients.
These participants will be divided into a 1:1 ratio to receive TNX-102 SL or placebo for 14 weeks.
Change from baseline in the weekly average of daily self-reported worst pain intensity scores at week 14 is the trial’s primary efficacy endpoint.
An interim assessment will be carried out on enrolling the first half of trial subjects for potential re-estimation of the sample size.
Tonix Pharmaceuticals CEO Seth Lederman said: “We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long Covid.
“Our study will focus on testing TNX-102 SL in the treatment of patients with multi-site pain associated with Long Covid.”
In July last year, the company announced the halting of subject enrolment in the Phase III RALLY trial of 5.6mg TNX-102 SL for fibromyalgia management.
The move comes after the Independent Data Monitoring Committee carried out an unblinded, pre-planned interim assessment of the initial 50% of study subjects and advised trial suspension due to futility.