Palm Beach, FL – June 11, 2024 – FN Media Group News Commentary – In the last twenty years, the amount of people with multiple sclerosis (MS) in the United States has more than doubled. In 2000, it was estimated by the National Multiple Sclerosis Society that around 400,000 Americans had the disease. In 2017, that estimate had jumped to 900,000. Although estimates between studies differ, it’s commonly accepted that about 800,000-900,000 individuals in the United States suffer from MS, out of a global population of 2-3 million total individuals with MS. The number of individuals with multiple sclerosis is rapidly increasing, and with no known cure, the demand for effective treatment has increased immensely. Reports from a National Institute of Health study conducted by Watson et. Al reveal that the current state of treatment for those suffering from MS is not generating positive outcomes for a majority of patients. When physicians who treated patients with multiple sclerosis were asked what the greatest unmet needs were with current disease modifying therapies (DMTs), they most frequently mentioned a lack of effectiveness in treating symptoms and effects, and failure to amply slow disease progression. For both primary and secondary progressive multiple sclerosis, in particular those with the non-active variant of the disease, patients frequently don’t receive treatment or their condition continues to get worse in spite of receiving treatment with existing DMTs. The population, already underserved, has exploded in the past two decades, making the need for a new treatment more critical than ever before. Active biotech and pharma companies in the markets this week include Tiziana Life Sciences, Ltd. (NASDAQ: TLSA), Eli Lilly and Company (NYSE: LLY), Roche Holding AG (OTCQX: RHHBY), Biogen Inc. (NASDAQ: BIIB), TG Therapeutics, Inc. (NASDAQ: TGTX).
A report from Fortune Business Insights projected that the global multiple sclerosis drugs market size was valued at USD 21.33 billion in 2023 and is projected to grow from USD 21.16 billion in 2024 to USD 38.94 billion by 2032, exhibiting a CAGR of 7.9% during the forecast period (2024-2032). The report said: “Multiple Sclerosis (MS) is an immune-mediated disease that affects the central nervous system. It is characterized by inflammation, demyelination, and degenerative changes such as progressive brain and spinal cord atrophy along with neuroaxonal loss. The number of people with multiple sclerosis across the globe increased from 2.3 million in 2013 to 2.8 million in 2020, according to the Multiple Sclerosis International Federation. The increasing prevalence of this relapsing remitting MS and primary progressive MS disease has increased the demand for effective diagnosis and treatment of multiple sclerosis globally. Hence, governments are actively supporting the treatment of multiple sclerosis. It continued: “The growth is attributed to the increasing focus on R&D to develop innovative drugs by major market players. Product launches, increasing government initiatives to improve the accessibility of treatment & care, and the rising prevalence of multiple sclerosis are expected to result in the global market expansion.”
Tiziana Life Sciences, Ltd. (NASDAQ: TLSA) Requests Fast Track Designation Approval From FDA for Treatment of Multiple Sclerosis — Tiziana Life Sciences, Ltd. (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted a request for intranasal foralumab to receive Fast Track Designation for the treatment of non- active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).
Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate shown to cause T regulatory (Treg) cell induction when dosed intranasally. At present, ten (10) na-SPMS patients have been dosed in an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program with clinically meaningful reduction in fatigue scores (MFIS) in 70% of patients, and stability of disease noted within six months in all ten patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, double-blind randomized, placebo-controlled, multicenter trial in patients with na-SPMS (NCT06292923). The Fast Track Designation request provided data from both animal models and clinical experience from the ISPPEA program. Foralumab would be the only intranasal monoclonal antibody designated as other Multiple Sclerosis monoclonal antibody therapies require intravenous or subcutaneous dosing. Fast Track Designation, if granted will affirm the serious disease condition and progressive disability seen in na-SPMS, and also the unmet medical need, as no therapies are currently approved for na-SPMS.
“Fast track is designed to expedite the review of drugs in development to treat serious conditions for which there are limited or no therapies,” commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. “The progressive nature of na-SPMS and lack of FDA-approved therapies for this disease aligns with the Food and Drug Administration’s criteria for Fast Track Designation. The increased interaction and partnership with the FDA afforded by this designation would be a tremendous asset to our foralumab development program, if granted,” he added. CONTINUED… Read these full press releases and more news for TLSA at: https://www.tizianalifesciences.com/news/
Other recent developments in the biotech industry of note for cancer events include:
Eli Lilly and Company (NYSE: LLY) recently announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. The efficacy estimandi showed 51.8%, 62.8% and 73.3% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology compared to 13.2% of participants on placebo at 52 weeks of treatment, meeting the study’s primary endpoint. The data were presented at the European Association for the Study of the Liver (EASL) Congress 2024 and simultaneously published in The New England Journal of Medicine (NEJM).
In a secondary endpoint, the efficacy estimand showed 59.1%, 53.3% and 54.2% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved a 1-stage or greater fibrosis improvement without worsening of MASH compared to 32.8% of participants on placebo. Evaluation of additional secondary endpoints showed tirzepatide was associated with improvements in body weight, blood markers of liver injury, and biomarkers of liver fat, inflammation and fibrosis. While the phase 2 study was not designed to prove that tirzepatide improves fibrosis, the study results showed the potential for a clinically meaningful treatment effect across all doses.
Roche Holding AG (OTCQX: RHHBY) recently announced new five-year data confirming the sustained efficacy and safety profile of Evrysdi® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA) from the open-label extension of the pivotal FIREFISH study. By the end of Year 5, 91% of children treated with Evrysdi were alive, 81% were alive without permanent ventilation and the majority were able to sit without support for at least 30 seconds (59%). At the end of year 5, seven children were able to stand, three with support, four unaided and six could walk with support. Without disease modifying treatment, natural history studies indicate that children with Type 1 SMA would not only never be able to reach such milestones, but also not typically live past the age of two. The data were presented at the Cure SMA Research & Clinical Care Meeting, June 5 – 7, 2024.
“These long-term findings confirm the ongoing benefit of Evrysdi for children with Type 1 SMA,” said Professor Giovanni Baranello, M.D., UCL Great Ormond Street Institute of Child Health & Great Ormond Street Hospital, London, UK. “Children treated with Evrysdi over five years have maintained or improved their ability to sit, stand and walk – critical skills for development and daily living. An overwhelming majority also maintained the ability to swallow and to eat without a feeding tube.”
Biogen Inc. (NASDAQ: BIIB) recently announced the European Commission (EC) has granted marketing authorization under exceptional circumstances and maintained orphan designation for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 gene (SOD1-ALS). QALSODY is the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease (MND).
“The European Commission’s approval of QALSODY is a testament to the unwavering dedication of the ALS community – people living with ALS and their loved ones, scientists, clinicians, and advocates – who have worked together over the past two decades to bring forward this important new treatment for the SOD1-ALS community,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular Development Unit at Biogen. “We are working with the medical community and local authorities to bring QALSODY to people living with SOD1-ALS across the region as quickly as possible.”
TG Therapeutics, Inc. (NASDAQ: TGTX), recently announced presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. Presentations are now public and can be viewed using the below links.
Presentations are available on the Publications page, located within the Pipeline section, of the Company’s website at https://www.tgtherapeutics.com/publications/. ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline.
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