Tonix's Therapeutic Development Program is Aligned with National Goal for Better Solutions

TONIX: Effect of TNX-102 SL on Fatigue in Proof-of-Concept Phase 2 Study Sets Stage for Developing Protocols for Registrational Phase 3 Study in Fibromyalgia-type Long COVID.

CHATHAM, NJ / ACCESSWIRE / October 25, 2023 / COVID is an acute disease that comes and goes, but for a growing number of people, the sequelae to the infection - the aftereffects - can become a constellation of symptoms called long COVID that may affect sufferers for years, if not a lifetime.

According to the CDC, Long COVID affects about 19% of people who recover from COVID. This common and growing problem has caught the attention of the Biden Administration, which recently released details of a program¹ to develop therapies and other treatments for long COVID as part of the previously announced RECOVER initiative that was funded by Congress with $1.15 billion. The symptoms of long COVID typically include fatigue, pain, non-restorative sleep and brain fog.

One of the leaders in developing drugs to promote restorative sleep in long COVID is Tonix Pharmaceuticals (NASDAQ:TNXP) which recently reported topline results from a Phase 2 proof-of-concept study evaluating drug candidate TNX-102 SL. They are developing TNX-102 SL as a treatment for fibromyalgia-type long COVID, which is a subgroup that is believed to include about 40 percent of long COVID patients. NIH has also recognized that identifying subgroups of long COVID is a key step in identifying treatments.²

In the 63-patient, double-blind, placebo-controlled study, TNX-102 SL showed an effect size of 0.5 in improving fatigue, which the company considers favorable for a proof-of-concept study. TNX-102 SL also showed consistent activity trending to improvements across the secondary endpoints of sleep quality, cognitive function, disability, and patient global impression of change. TNX-102 SL tended towards improvement but did not achieve the pre-specified primary endpoint of improving long Covid pain intensity scores at Week 14. TNX-102 SL demonstrated a favorable tolerability profile with no new safety signals and no serious adverse events.

The study, called PREVAIL, was designed and conducted to guide the design of registrational studies of TNX-102 SL in fibromyalgia-type long COVID. While fibromyalgia and long COVID have several overlapping symptoms, patients with long COVID and fibromyalgia prioritize different symptoms. Fibromyalgia patients complain most about pain, while long COVID patients complain most about fatigue.

"The activity of TNX-102 SL on fatigue in long COVID patients is particularly encouraging because fatigue is the chief complaint of many patients," said Seth Lederman, MD, CEO of Tonix. "Overall, the findings fulfilled the objectives we had for the study and support our decision to advance the program based on a new proposed primary endpoint using the PROMIS Fatigue scale."

Tonix intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss a potential Phase 3 program based on a primary outcome measure using the PROMIS Fatigue scale. The meeting is expected to take place in the first quarter of 2024.

Tonix has been developing TNX-102 SL primarily as a treatment for fibromyalgia and is well into its second Phase 3 trial for that indication. It's a bedtime, sublingual medicine, with no known addiction properties.

Tonix recognized that poor sleep is not just one of the symptoms of fibromyalgia, but may be an Achilles heel of the disorder. TNX-102 SL is designed to improve sleep quality -not sleep quantity-- and the company believes that improving sleep quality leads to improvement in the other symptoms, like fatigue and pain.

In a Phase 3 clinical trial in fibromyalgia, TNX-102 SL was shown to significantly reduce daily pain, improve sleep quality, and reduce fatigue when taken once daily at bedtime. Pain scores dropped 1.91 points on an 11-point scale for patients treated with TNX-102 SL, compared to 1.51 percent for the placebo group (p=0.010). And in a responder analysis, more than 46 percent of patients who received the treatment saw pain reduced compared to 35 percent in the placebo group.

The second and potentially confirmatory Phase 3 trial in fibromyalgia is expected to report topline results before year-end. If positive, the company believes the 457-patient trial would provide the final data required for filing an NDA for marketing approval. There hasn't been a new drug for fibromyalgia approved by the FDA in more than a dozen years.

The fibromyalgia data spurred Tonix to launch a separate clinical program in hopes of providing relief to Long COVID patients. Tonix recognized that the common symptoms of long COVID overlap with fibromyalgia, so they launched a program to test the activity of TNX-102 SL treatment on multiple symptoms in long COVID.

The importance of a non-addictive therapy for fibromyalgia and long COVID can't be over emphasized. In an analysis of a public health database commissioned by Tonix, 35 percent of Long COVID patients experiencing multi-source pain used opioids to treat the pain. Among those that experienced sleep problems and multi-source pain, the rate of opioid use jumped to 50 percent.

According to the U.S. Department of Labor, 29 percent of patients who are prescribed opioids, even for short-term treatment, will end up misusing them while 12 percent will develop an addiction. The longer a patient relies on these drugs, the higher the risk of becoming dependent on them.

Interestingly, the NIH just recently formally recognized that targeting sleep quality¹ is a promising approach to treating Long COVID. This new initiative follows Tonix's long-advocated approach of treating sleep quality with TNX-102 SL in fibromyalgia and long COVID. In both fibromyalgia and Long COVID, sleep symptoms are recognized problems, but Tonix recognized early on that treating the sleep problems could improve the other symptoms such as fatigue and widespread pain.

Featured photo by Zamrznuti tonovi on shutterstock.

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Important notice, please read: Certain statements in this document are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the "SEC") on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

¹NIH news release July 31, 2023: https://www.nih.gov/news-events/news-releases/nih-launches-long-covid-clinical-trials-through-recover-initiative-opening-enrollment
²Thaweethai T, et al. JAMA. 2023 Jun 13;329(22):1934-1946.

SOURCE: Tonix Pharmaceuticals