• Fibromyalgia candidate TNX-102 SL hits primary endpoint of daily pain reduction (p=0.00005)
• Combination of broad-spectrum relief and favorable tolerability seen as distinguishing, competitive features
• Company plans to file an NDA for FDA approval in 2H 2024

CHATHAM, NJ / ACCESSWIRE / February 1, 2024 / Tonix Pharmaceuticals (NASDAQ:TNXP) appears to have a potential new weapon against fibromyalgia for the 6-12 million adults in America suffering from its debilitating effects.

It has to do with sleep quality, not sleep quantity.

Tonix's candidate drug TNX-102 SL*, which just completed its second successful Phase 3 clinical trial, targets poor sleep quality - not sleep quantity - as the key mechanism to improve the daily lives of people afflicted with fibromyalgia.

Traditional sleeping pills, which are called sedatives or hypnotics, speed the onset of sleep, and increase the amount of time spent asleep. But these barbiturate, "benzo" or "non-benzo" type drugs often impair the quality of sleep. The quality of sleep is usually measured by how someone feels the next day. Fibromyalgia patients suffer from poor sleep quality. A core pathology of the fibromyalgia syndrome prevents affected patients from being able to get restorative sleep.

Tonix believes TNX-102 SL's ability to facilitate restorative sleep is what drove the successful efficacy and tolerability outcomes in two successful Phase 3 trials in the management of fibromyalgia. TNX-102 SL treatment is based on the hypothesis that poor sleep is an obstacle to recovery and that if the obstacle of poor sleep quality can be addressed, then fibromyalgia patients have a better chance at recovery.

A filing for marketing approval with the FDA is scheduled for the second half of this year, the company said.

"'I hurt all over and I can't sleep,' are the two most frequent complaints of fibromyalgia patients", says Seth Lederman, MD, the CEO of Tonix, who years ago cared for fibromyalgia patients at the rheumatology clinic at Columbia Medical School. He added, "Sometimes fibromyalgia patients will volunteer that a good night's sleep can bring relief."

The company's latest Phase 3 trial in fibromyalgia (457 patients randomized 1:1 drug to placebo) showed TNX-102 SL successfully improved sleep quality over placebo with a highly significant p-value of 0.0000001 in the PROMIS sleep scale and achieved its primary endpoint of daily pain reduction with a highly statistically significant p-value of 0.00005.

Improved Sexual Function in Women

"We believe the overall success of the trial and the strength of the effect on the primary endpoint are due to the kind of sleep fibromyalgia patients experience when they are taking TNX-102 SL therapy," says Dr. Lederman. "Our studies have shown TNX-102 SL increases sleep quality in fibromyalgia. Beyond sleep and pain, TNX-102 SL also improves other key characteristics of the fibromyalgia syndrome. For example, TNX-102 SL treated patients had less fatigue, fewer symptoms and better function. So far, TNX-102 SL has not shown any effects on weight or blood pressure in our trials. In addition, in the latest study, TNX-102 SL therapy improved sexual function in women as measured by the CSQ-14 score."

TNX-102 SL's ability to reduce pain, coupled with its tolerability and favorable side effects profile, may give hope to fibromyalgia patients. If approved by the FDA, TNX-102 SL would be the first new drug approved for fibromyalgia in more than a dozen years. It would also be the first member of a new class of drugs for fibromyalgia, since it has a totally new mechanism of action, relative to the three drugs that have been approved.

Three drugs have been FDA-approved for fibromyalgia, but their long-term use is often problematic due to side effects. Widespread dissatisfaction with the current medicines is reported. The three currently FDA-approved medicines for fibromyalgia are Cymbalta®, Lyric®, and Savella®. They are generally thought to be effective in reducing pain. None is associated with improvements in both sleep and fatigue, like TNX-102 SL. Some of the treatment-limiting side effects of these medicines include weight gain, blood pressure, and sexual dysfunction.

Despite these shortcomings, Cymbalta and Lyrica, both now off patent, enjoyed combined annual peak sales of approximately $10 billion.

The unmet treatment needs in fibromyalgia lead many patients to switch frequently between approved drugs, and then to off-label drugs, home remedies, and addictive opioids.

"Fibromyalgia is a chronic condition that often persists for decades. It can be treated, but there is no cure yet", Dr. Lederman adds. "Adherence to the prescribed medicines is critical to achieving the best outcomes. Therefore, tolerability is important. We think TNX-102 SL has the potential to be a first-line medicine suitable for long-term use in managing fibromyalgia."

The recently reported RESILIENT Phase 3 trial and the earlier Phase 3 RELIEF trial completed in 2020 position the company to submit a New Drug Application (NDA) to the FDA under the 505(b)(2) regulatory approval pathway, which it plans to do in the second half of 2024. The company said it is on track to supply the U.S. market upon FDA approval.

Tonix has several other category-leading drug candidates in development. Among them are TNX-2900 for Prader-Willi syndrome, TNX-1500 for organ transplant rejection and autoimmune diseases, and TNX-1300, an antidote to cocaine intoxication.

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*Tonix's product development candidates, including TNX-102 SL, are investigational new drugs or biologics and have not been approved for any indication.

Featured photo by National Cancer Institute on Unsplash.

Disclosures

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 failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; 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") in March 2023, and periodic reports filed with the SEC on or after the date thereof. All 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.

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