Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) is screaming for the top in the market this morning, and for good reason. The company announced positive data from a late-stage fibromyalgia study, whcih could change the game for the company and those suffering fromt his rare condition. Here’s what’s going on:
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TNXP Stock Climbs On Positive Lage-Stage Study Data
In the press release, Tonix Pharmaceuticals said that TNX-102 SL met its pre-specified primary endpoint. That endpoint was to significantly reduce daily pain in patients with fibromyalgia when compared to placebo.
The data came from the Phase 3 RELIEF study. The study assessed TNX-102 SL, which is a novel, non-opiod, centrally-acting analgesic. TNXP explained that the treatment is designed to be taken once daily at bedtime.
The clinical trial assessed the 5.6 mg dose of TNX-102 SL. The study included 503 participants with fibromyalgia, who were randomized at a 1:1 ratio across 39 sites in the United States. For the first two weeks, patients in the trial either received one tablit of TNX-102 SL 2.8 mg or placebo. For the remaining 12 weeks, the dose size on the treatment arm was increased to 5.6 mg.
The data suggest that not only did the treatment lead to a statistically significant reduction in pain, it also proved to be safe and well-tolerated. In a statement, Seth Lederman, M.D., President and CEO at TNXP, had the following to offer:
Tonix is dedicated to improving the lives of the millions suffering from fibromyalgia, approximately 90% of whom are female, and the results of the RELIEF trial bring new hope to this community. TNX-102 SL at 5.6 mg showed statistically significant and clinically meaningful improvement on the primary endpoint of reducing daily pain, as well as showed activity in key secondary endpoints of improving sleep and reducing fatigue. One of the biggest challenges in drug development is finding a dose that balances efficacy and tolerability. We are pleased with the consistent effects of TNX-102 SL 5.6 mg on the primary endpoint of daily pain as well as the tolerability of this dose in the RELIEF study. We are also pleased at the activity shown on all of the fibromyalgia specific, pre-specified secondary endpoints.
We look forward to the results of the currently enrolling, second potential pivotal Phase 3 study, RALLY, for which we expect to report topline data in the second half of 2021. Based on the long term safety exposure data we have already collected, the mature stage of our Good Manufacturing Practice (GMP) manufacturing processes and the established product stability at 36 months, we believe that upon achieving positive results from the currently enrolling RALLY study, we may potentially be in a position to submit a New Drug Application (NDA) for TNX-102 SL for fibromyalgia to the U.S. Food and Drug Administration (FDA) in 2022. Additionally, we believe that our commercial manufacturing is on track to supply the U.S. market in 2022.
These results support the proposed mechanism in which TNX-102 SL targets disturbed sleep in fibromyalgia and that improved sleep quality leads to improvement of fibromyalgia at the syndromal leve. The sleep disorder specific to fibromyalgia has been called ‘non-restorative’ sleep. Dr. Harvey Moldofsky, Professor emeritus of Psychiatry and Medicine at the University of Toronto, founding Director of the University of Toronto Center for Sleep and Chronobiology, and Member of the Tonix Scientific Advisory Board, first recognized the central role of non-restorative sleep in the pathogenesis of fibromyalgia.
Our program is based on the subsequent pioneering work of Dr. Iredell W. Iglehart III, Assistant Professor of Medicine, part-time, Division of Rheumatology, Johns Hopkins School of Medicine, and Member of the Tonix Scientific Advisory Board, who recognized that a sleep-focused cyclobenzaprine treatment protocol had the potential to target non-restorative sleep and lead to improvement of fibromyalgia at the syndromal level5. Transforming this treatment paradigm into a potential product with the clinical activity described in the RELIEF study depended on the invention of the Protectic® and Angstro® technologies. These technologies are integral to TNX-102 SL, which is a sublingual tablet designed for transmucosal delivery of cyclobenzaprine with distinctive pharmacokinetic properties that include bypassing first-pass hepatic metabolism. Teams led by Giorgio Reiner at APR Applied Pharma Research S.A. and Professor Marino Nebuloni and Patrizia Colombo at Redox Analytical Science Srl invented and developed these underlying technologies in collaboration with Tonix.
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This News Is Huge
The news released by Tonix Pharmaceuticals this morning proved to be overwhelmingly positive. Fibromyaligia is a debilitating condition that I’ve personally seen the effects of in a very close family member. Her struggles have been serious and the pain is intense. In fact, when I was a kid and we went to theme parks, or anywhere you needed to walk a long distance, she would be wheelchair bound.
Even today, there aren’t many treatment options, and most of the options available are either opiod or come with other serious side effects. With that said, I’m happy to see that TNXP data was overwhelmingly positive. Not only for the investing community, but for a member of my family.
With the Phase 3 data now on the table, the next step for the company will be to seek FDA approval. Considering the fact that fibromyalgia is a rare condition, and the data is promising, I’m expecting that the FDA will approve the treatment rather than reject it, but that’s a bit of time away.
Nonetheless, with this data in hand TNXP stock just became far more exciting.
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