View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
April 7, 2022

Tonix’s application for Phase II Long Covid therapy trial cleared by FDA

The Phase II trial of TNX-102 is expected to start in the second quarter of this year.

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.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU