Globenewswire | August 14, 2023
Tonix Pharmaceuticals Holding Corp. a biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL as a potential treatment for fibromyalgia-type Long COVID. Topline results for the PREVAIL study are expected in the third quarter of 2023.
“Approximately 40% of U.S. Long COVID patients have fibromyalgia-like multi-site pain symptoms based on our observational studies of Long COVID patients from the TriNetX claims database,”2,3 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In addition to multi-site pain, these individuals often suffer from one or more other symptoms typically associated with fibromyalgia such as fatigue, sleep disturbance, and brain fog. We have termed this subgroup, ‘Fibromyalgia-type Long COVID.’ Given our encouraging results with TNX-102 SL as a potential treatment for fibromyalgia4, we are testing TNX-102 SL as a bedtime medicine for the management of Fibromyalgia-type Long COVID. In completing this clinical milestone, marked by the last enrolled patient finishing their final visit, we can now begin to look forward to topline results from the 63-patient PREVAIL study later this quarter.”
Dr. Lederman continued, “TNX-102 SL improves sleep quality in fibromyalgia, and we believe this is the mechanism by which TNX-102 SL improves other symptoms, like multi-site pain.5 Recently, the U.S. National Institutes of Health (NIH) has identified improving sleep quality as a target for potential therapeutics for Long COVID6,7,8, consistent with the proposed mechanism of TNX-102 SL.
“Common symptoms of Long COVID, including multi-site pain, fatigue, unrefreshing sleep, and cognitive dysfunction, or ‘brain fog,’ are also hallmarks of conditions like fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME),”9 said Herbert Harris, M.D., Ph.D., Executive Vice President and Head of Translational Medicine of Tonix Pharmaceuticals. “Defining subgroups of Long COVID patients that overlap with fibromyalgia and CFS/ME is expected to facilitate the development of new treatments.4 It can be challenging to distinguish fibromyalgia and CFS/ME clinically, given the high level of symptom overlap between them. Each of these conditions is defined by a constellation of symptoms, and there is no widely recognized diagnostic laboratory test that distinguishes them.”
Dr. Harris continued, “The recent identification of Long COVID subgroups in the National Institutes of Allergy and Infectious Diseases (NIAID)-sponsored RECOVER study10 was an important step. In their recent publication, cluster analysis of the symptom frequencies in the RECOVER study identified four subgroups of Long COVID patients. Cluster #4 represented approximately one-quarter of the population (28%) and reported the highest frequencies of pain (back pain (58%), joint pain (64%) or muscle pain (60%)), high frequencies of fatigue (94%) and ’Brain Fog,’ (94%) and a high level of impairment of Quality of Life. We believe Cluster #4 is a subgroup of Long COVID that shares many clinical features with fibromyalgia and may involve common disease mechanisms. We also believe that Cluster #3, representing another approximately 29% of the RECOVER cohort, includes many patients with fibromyalgia-type Long COVID because 100% of that group suffer from ‘Brain Fog’, 94% experience fatigue and approximately one-third
experience pain (back pain (32%), joint pain (36%) or muscle pain (34%)).”
Dr. Harris concluded, “With no FDA approved treatment for Long COVID, we understand the need to better understand long COVID and to develop treatments for subgroups of this unserved population of patients. Fibromyalgia has been recognized by the U.S. Food and Drug Administration (FDA) with three approved medicines. Consequently, measuring daily pain is a validated endpoint for FDA registrational studies in fibromyalgia. We believe that daily pain has the potential to be an endpoint for registrational studies in fibromyalgia-like long COVID.”
About the Phase 2 PREVAIL Study
The Phase 2 PREVAIL study is a 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-CoV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. The primary efficacy endpoint will be the change from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue, and cognitive function. Topline results are expected in the third quarter of 2023.
About Long COVID or Post-Acute Sequelae of COVID-19 (PASC)
Post-acute sequelae of COVID-19, or PASC is the formal name for a condition now widely known as Long COVID. Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develops a chronic syndrome called Long COVID.11 These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. According to the Centers for Disease Control and Prevention (CDC), 1 in 13 adults in the U.S. (7.5%) have Long COVID symptoms.1 Long COVID is typically associated with moderate or severe COVID-19, but can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. More than 40% of adults in the United States reported having COVID-19 in the past, and nearly one in five of those (19%) are currently still having symptoms of Long COVID.1 Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.12-15
About TNX-102 SL
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder and agitation in Alzheimer’s disease.
AboutTonix Pharmaceuticals Holding Corp.
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023.
Businesswire | August 24, 2023
TailorMed, a leading technology company offering the nation’s largest network of patients, providers, pharmacies, life science companies, and other partners dedicated to improving healthcare affordability, today announced it is collaborating with TwelveStone Health Partners. TwelveStone, which provides comprehensive chronic care medication services, has confidently invested in TailorMed’s best-in-class solutions to remove financial barriers for patients with high-cost conditions.
The cost of specialty drugs, including infused therapies, is rising rapidly. In fact, the average annual cost for one specialty medication is estimated to be at least $84,000. These staggering expenses often lead to medication nonadherence and prescription abandonment. Financial assistance programs help eligible patients pay for treatment, yet these resources remain underutilized. TailorMed offers a comprehensive solution by empowering providers and pharmacies to proactively flag patients in need. The technology then matches patients with relevant funding opportunities, drawing on more than 6,000 resources ranging from drug manufacturer copay assistance to foundation grants. TwelveStone Health Partners will use the company’s enterprise platform to improve access to critical therapies for patients who could not otherwise afford them.
“This partnership enhances our commitment to expanding patient access and addressing affordability to ensure that those who need them most can receive innovative medications in a warm, caring, patient-centric care environment,” said Shane Reeves, chief executive officer, TwelveStone Health Partners. “TailorMed’s technology provides real value to our patients who deserve a higher level of care and support.”
The process of connecting patients with financial assistance has historically been an arduous and highly manual process. The TailorMed platform will significantly reduce the administrative burden for TwelveStone Health Partners, allowing staff to efficiently address patients’ financial needs. The company’s Pharmacy solution will also enable staff to streamline the management and tracking of free and replacement drug orders.
“We’re very proud to collaborate with leading specialty pharmacies and infusion centers such as TwelveStone Health Partners as our network continues to expand,” said Bryan Bloom, head of enterprise sales at TailorMed. “By leveraging our solutions to tackle affordability, TwelveStone will be better equipped to provide superior patient experiences, while ensuring no one falls through the cracks due to costs.”
Srulik Dvorsky, co-founder and chief executive officer at TailorMed, also shared: “We are especially pleased to add TwelveStone Health Partners to our growing list of infusion center clients. As a company committed to innovating at scale, we want to do everything we can to ensure our partners can also deliver care at scale.”
TailorMed offers the nation’s largest network of patients, providers, pharmacies, partners, and life science companies focused on ensuring all patients across all medical conditions can afford treatment. Driven by TailorMed's best-in-class platform, network constituents can proactively identify, match, and enroll patients in financial assistance programs to deliver a world-class patient financial experience while reducing the cost of care delivery and increasing revenues. TailorMed’s secure, web-based financial assistance solutions are deployed across more than 1,000 sites of care, including Providence Health, UnityPoint Health, Yale-New Haven Health, and Advocate Aurora Health.
About TwelveStone Health Partners
TwelveStone Health Partners incorporates the objective of glorifying God into its mission by delivering a higher level of service to partners and patients. As an organization, TwelveStone supports the transition from acute to post-acute care environments and the transition from sickness to health. Founded in 2016 TwelveStone is the third iteration of pharmacy organizations founded by Shane Reeves and the Reeves family. Today TwelveStone is rapidly expanding across the Southeast anchored by spa-like infusion centers conveniently located in suburban communities supported by additional services including package medications, home infusion, enteral and injections. TwelveStone is dedicated to providing the highest level of care to those with chronic, complex conditions in the environment that is most convenient for both the patient and their loved ones.
PRNewswire | July 27, 2023
Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company.
XERAVA® is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections.
"The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia."
"Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance."
"Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections."
In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible.
XERAVA® is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive , gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections in the US, EU, GB, Singapore, mainland China, Hong Kong and the medicine is currently under review for cIAI in Taiwan region. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.