Ritlecitinib Tosilate

Soterios Pharma announced Thursday that its investigational topical hair-loss therapy STS-01 met the primary and key secondary endpoints of a Phase II study of patients with alopecia areata.According to the company, STS-01 functions by disrupting signalling pathways to modulate the inflammatory response and T-cell proliferation.The mid-stage study enrolled 158 patients with mild or moderate alopecia areata, who were randomised to receive either one of four doses of STS-01 (0.25%, 0.5%, 1% or 2%) or placebo for 24 weeks. The primary endpoint was >30% improvement on the Severity of Alopecia Tool (SALT) score, while secondary endpoints included total hair regrowth with the 1% and 2% doses of STS-01.Topline results showed that after 24 weeks, 75.9% of participants treated with 1% STS-01 achieved the main goal, compared with 36.7% of placebo recipients. Moreover, 19% and 27% of participants on 1% and 2% STS-01, respectively, achieved total hair regrowth (SALT 0) compared with 3% of those on placebo. The company said the drug was well tolerated, with no major adverse events. Detailed findings will be presented at a forthcoming medical conference. "This data gives us clarity and confidence in moving into late-stage clinical development for this product,” said CEO David Fleet.While systemic JAK inhibitors such as Eli Lilly and Incyte’s Olumiant (baricitinib) and Pfizer’s Litfulo (ritlecitinib) have been approved in the US for severe alopecia areata, there remains an unmet treatment need for individuals with mild or moderate disease, who account for more than half of the 800,000 patients with the condition in the US, Soterios said.

Draft guidance published in September 2023 did not recommend Enhertu for breast cancer patients post-chemotherapy. Credit: ORION PRODUCTION / Shutterstock.com. The UK National Institute for Health and Care Excellence ( Nice ) has declined to recommend Daiichi Sankyo ‘s Enhertu (trastuzumab deruxtecan) for the treatment of advanced HER2-low breast cancer in adults. The final draft guidance comes after unsuccessful negotiations between National Health Service (NHS) England and Daiichi Sankyo to reach a cost-effective commercial deal to offer the therapy for NHS use. The appraisal of Enhertu by NICE had been on hold since December 2023 while discussions were underway. Draft guidance published in September had already set a precedent by not recommending Enhertu for patients post-chemotherapy, citing uncertainties in the data and cost-effectiveness that exceeded the institute’s acceptable range for NHS resource use. Approximately 1000 individuals would have been eligible for treatment with Enhertu if recommended. See Also: MorphoSys files patent for antibodies for treating inflammatory, autoimmune diseases, or cancer Kura Oncology files patent for combination treatment for head and neck cancer Registered consultees, including Daiichi Sankyo and patient carer groups, can appeal against the final draft recommendations. NICE maintains its position of not endorsing Enhertu for NHS use without a commercial arrangement that leads to a cost-effective price. NICE medicines evaluation director Helen Knight stated: “We are extremely disappointed not to be able to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer. “The backdrop to the commercial discussions was the independent appraisal committee’s belief that, based on the available evidence, Enhertu represents a significant development for people with HER2-low advanced breast cancer who currently have limited chemotherapy options. Most have no targeted treatments available to them. “However, a key uncertainty in estimating Enhertu’s cost-effectiveness was how much longer people on Enhertu live compared with those receiving standard treatment in the future. The independent committee carefully considered all the evidence and applied its judgement on the most clinically plausible approach on which to base its decision.” The latest development comes after NICE recommended Pfizer ‘s ritlecitinib as a new treatment option for severe hair loss associated with alopecia areata .