Coya Therapeutics announced publication of a longitudinal biomarker study led by Dr David Beers and Dr Stanley Appel in Annals of Clinical and Translational Neurology. The analysis used serum samples collected from January 2018 to December 2022 and compared 100 randomly selected patients with sporadic or familial ALS to 100 age and sex matched healthy controls.
Investigators measured 4-hydroxy-2-nonenal (4-HNE), lipopolysaccharide binding protein (LBP) and neurofilament light chain (NfL) by ELISA. All three biomarkers were higher in patients with ALS than in controls. Levels of 4-HNE and LBP were elevated at diagnosis and rose with disease progression and correlated with progression rates and survival (p < 0.001 for 4-HNE and LBP). NfL was elevated at diagnosis with a more limited increase over time and correlated with survival (p = 0.001).
The biomarker findings are consistent with a previously reported investigator-initiated trial in which subcutaneous low-dose interleukin 2 and CTLA-4 Ig reduced these biomarkers and increased regulatory T cell function, with no functional decline over a 48-week treatment period. According to the company, Coya is now evaluating COYA 302, a combination of LD IL-2 and CTLA-4 Ig, in the Phase 2 ALSTARS randomized, double blind, placebo-controlled trial. COYA 302 is investigational and not approved by the FDA. The release also reiterated general ALS statistics and clinical course cited by the company.
