a Therapeutics(US:COYA)2026-02-17 21:02Summary of Coya Therapeutics Update - February 17, 2026 Company Overview - Company: Coya Therapeutics (NasdaqCM: COYA) - Focus: Development of targeted therapies for ALS (Amyotrophic Lateral Sclerosis) Key Industry Insights - ALS Treatment Landscape: The approval of tofersen for SOD1 ALS has marked a significant development, indicating that targeted therapies can have a substantial impact on the disease's biology, potentially slowing, halting, or even reversing progression for a small subset of patients [3][4] - Current Therapies: Existing therapies show only modest benefits due to a lack of focus and understanding of the disease's biology. The industry is shifting towards more biologically informed clinical trials [5][6] Core Scientific Insights - Neuroinflammation: Neuroinflammation is identified as a critical factor in ALS pathology. The understanding of its role has evolved, with a focus on specific biological processes rather than broad observations [6][12] - Regulatory T Cells (Tregs): Tregs are crucial for neuroprotection but are dysfunctional in ALS patients. Enhancing Treg function is a potential therapeutic target [13][14] Combination Therapy Rationale - Combination of Low-Dose IL-2 and CTLA-4: The rationale for this combination therapy is based on the need to enhance Treg function while suppressing inflammatory responses from activated macrophages. This dual approach aims to prevent Treg dysfunction and improve therapeutic outcomes [16][18][19] Clinical Trial Insights - Initial Study Results: A small study involving four ALS patients showed promising results, with some patients experiencing slowed progression and improved biomarkers related to inflammation and oxidative stress [24][25][26] - ALSTARS Phase 2 Trial: The upcoming trial aims to enroll 120 patients, with a design that includes a placebo group and two different dosing regimens for the combination therapy. The trial will measure clinical outcomes and biomarkers over six months [40][41][42] Safety and Tolerability - Safety Profile: Previous studies indicate that both IL-2 and CTLA-4 have favorable safety profiles, with no significant increase in infection rates observed. The low-dose IL-2 specifically activates Tregs without causing pro-inflammatory responses [56][59] Future Considerations - Potential for FDA Approval: If the trial meets its primary efficacy endpoint, Coya plans to submit an application for FDA approval. The strength of the data will be crucial for this process [65][66] - Long-Term Outcomes: There is optimism that slowing disease progression could correlate with improved survival rates, although ongoing monitoring of inflammation levels will be essential [62][64] Conclusion Coya Therapeutics is at the forefront of developing targeted therapies for ALS, with a strong focus on understanding the underlying biology of the disease. The upcoming ALSTARS trial represents a significant step towards validating the efficacy of combination therapies aimed at neuroinflammation and Treg dysfunction.