Data highlights TNX-102 SL’s potential as a treatment for sleep disturbances associated with fibromyalgia-type long COVID, as well as PTSD.

Summary: Tonix Pharmaceuticals announced two poster presentations at the American Society of Clinical Psychopharmacology annual meeting showcasing the effects of TNX-102 SL on sleep disturbances in fibromyalgia-type long COVID and PTSD. The phase 2 study on fibromyalgia-type long COVID showed significant improvements in fatigue, sleep quality, and cognitive function, though it did not meet the primary pain reduction endpoint. Another study, the OASIS trial, will evaluate TNX-102 SL’s impact on acute stress reaction and PTSD in civilians post-trauma. TNX-102 SL was well tolerated with no new safety signals.

Key Takeaways:

In the phase 2 PREVAIL trial in fibromyalgia-type long COVID, bedtime TNX-102 SL resulted in a signal in fatigue, sleep, and cognitive function.
The OASIS trial will evaluate the drug’s effectiveness in reducing acute stress reactions and preventing PTSD following trauma.
TNX-102 SL was well tolerated, with an adverse event profile consistent with prior studies and no new safety concerns.

Tonix Pharmaceuticals Holding Corp announced two poster presentations at the American Society of Clinical Psychopharmacology annual meeting, showing the effects of TNX-102 SL on sleep quality and fatigue in fibromyalgia-type Long COVID and its potential in treating acute stress reaction and post-traumatic stress disorder (PTSD).

Improving Sleep and Fatigue in Long COVID Patients

In the poster presentation titled, “Effect of bedtime sublingual cyclobenzaprine (TNX-102 SL) on pain, sleep, fatigue, and cognition in fibromyalgia-type long COVID: results of a double-blind randomized proof-of-concept phase 2 study,” TNX-102 SL showed “a robust effect size” of 0.5 in improving fatigue and consistent activity across secondary measures of sleep quality, cognitive function, disability, and Patient Global Impression of Change, but did not meet the primary endpoint of multi-site pain reduction at week 14.

Prior to the trial, Tonix had pre-specified that any effect size greater than 0.2 would be considered of interest for further study, and even given a substantial placebo response in pain magnitude measurements, key endpoints such as sleep quality diary (ES = 0.23), PROMIS Sleep Disturbance (ES = 0.32), PROMIS Fatigue (ES = 0.50), PROMIS Cognitive Function (ES = 0.21), the Insomnia Severity Index (ES = 0.24) and the Sheehan Disability Scale (ES = 0.26) all matched the criterion for further evaluation.

TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.

“These results further support the growing evidence that for most long COVID patients, symptoms are at least partly driven by central nervous system mechanisms rather than persistent exposure to the SARS-CoV-2 virus,” says Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in a relese. “While Tonix is preparing for submission of a New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia (branded Tonmya), we believe that these results demonstrate it may also be effective in managing pain and aiding in sleep quality for patients with fibromyalgia-type Long COVID, further indicating that, for many patients, long COVID should be viewed in the context of a chronic overlapping pain condition like fibromyalgia or chronic fatigue syndrome/myalgic encephalomyelitis framework.”

Reducing Acute Stress Reaction and PTSD Symptoms

In the poster presentation titled, “Optimizing acute stress reaction (ASR) interventions with TNX-102 SL* (sublingual cyclobenzaprine HCl) – the OASIS trial: Sustaining civilian performance post-trauma by reduction of ASR and prevention of ASD/PTSD,” TNX-102 SL will be evaluated for the reduction in severity of ASR and the frequency of acute stress disorder (ASD) and PTSD in civilians after a motor vehicle collision.

To reduce the persistence of ASR symptoms and the rate and severity of ASD and PTSD, it may be critical to intervene in the immediate aftermath of trauma. Currently, there are no medications available at or near the point of care to treat patients suffering from acute trauma and support long-term health. Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms in as early as two weeks with favorable tolerability. The first participant for the OASIS trial is expected to enroll in the second quarter of 2024.

“Previous trials of TNX-102 SL in PTSD suggested activity on sleep and stress-related symptoms in the first several weeks of treatment,” says Lederman in a release. “The study is motivated by the observation that the symptoms of ASR and PTSD are similar and by the hypothesis that TNX-102 SL’s effect on sleep quality may reduce ASR symptoms, possibly providing military personnel, veterans, and civilians with a new treatment option that, when administered in the early aftermath of a traumatic event, improves recovery, job performance, and quality of life.”

TNX-102 SL is a centrally acting, non-opioid medication, and under the trade name Tonmya, Tonix remains on track to submit an NDA to the US Food and Drug Administration (FDA) in the second half of 2024 for the management of fibromyalgia. Tonix has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.