Tonix Pharmaceuticals Commences Mid-Stage Long COVID Study, Sees Interim Report In H1 2023

Tonix Pharmaceuticals TNXP has initiated patient enrolment in the Phase 2 PREVAIL study of TNX-102 SL for patients with Long COVID syndrome (Long COVID).

The Phase 2 PREVAIL study is a 14-weeks clinical trial to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with fibromyalgia-like multi-site pain associated with post-acute sequelae of SARS-COV-2 infection (PASC).

Seth Lederman, Chief Executive Officer, said, “Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia. We recognize the need to better understand and develop treatment for Long COVID.”

An interim analysis, after the first 50% of enrolled patients have completed the study, which is expected in the first half of 2023.

Long COVID or Post-Acute Sequelae of COVID-19 (PASC) is a constellation of disabling symptoms long past the time of recovery from acute COVID-19.

Fibromyalgia is considered one of the clusters of chronic overlapping pain conditions that have much in common with Long COVID.

Price Action : Tonix shares are trading around 1 percent down at $1.29 on Monday during pre-market session.