GLOBAL RESEARCH ARCHIVE
1Q26 Update. ALSTARS In Full Swing with Complete Enrollment in 2H26. FTD for COYA 302 in ALS - Useful with Plans Likely Involving Some Form of Accelerated Approval.
Research evidence excerpt
1Q26 Update. ALSTARS In Full Swing with Complete Enrollment in 2H26. FTD for COYA 302 in ALS - Useful with Plans Likely Involving Some Form of Accelerated Approval.
■ ...therapeutic as a monotherapy. We saw clearing the IND as an important event for the company as Coya planned additional
combinations with its low-dose formulation of IL-2, and acceptance of the IND would suggest the company and the FDA are
on the same page as to what a preclinical package must demonstrate.
■ Treg interest is high. The potential to harness Treg cells is coming of age as demonstrated by the awarding of the 2025 Nobel
Prize and Coya's recent publication (perhaps not in equal measures). Coya's paper in the high impact of the journal Nature
reviewed ongoing efforts in exploring the autoimmune response in ALS and continued to increase awareness of the role of
Tregs in ALS. High awareness has value both in recruiting clinical trials and helping regulators assess clinical data. The reported
results, in broad brushstrokes, support the model implicating neuroinflammation as a significant driver of disease progression
in ALS - stemming from an imbalance of inflammatory and non-inflammatory T-cell responses. Correspondingly, improvingBIOTECHNOLOGY
Treg function would serve as an effective therapy, based on the findings identifying a key target for antigen-specific T cell
responses.
■ Pipeline: After the unimpressive readout of the EVOKE trial testing GLP-1 agonists in AD patients, the COYA-303 programEQUITY may become a focus of investor interest at Coya. COYA-303 is a low dose IL2 in combination with a GLP-1 receptor agonist.
GLP-1 agonists are expected to help AD patients via their rapid improvement of the patients' vascular systems and IL-2 may
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