Study of COYA 302 for the Treatment of ALS (ALSTARS)

• El Escorial clinically probable, lab-supported probable, or definite ALS; sporadic or familial
• Age 18-80
• ≤36 months since ALS symptom (weakness in extremity, bulbar, or respiratory muscles) onset
• ALSFRS-R total ≥35 at Screening
• deltaFRS at Baseline between -0.5 & -1.5 points/month
• SVC ≥ 70% of predicted capacity
• Stable dose of riluzole, edavarone and/or tofersen

• To evaluate the safety and efficacy of COYA 302, a combination therapy comprised of low dose interleukin-2 (LD IL-2) and DRL_AB (a biosimilar candidate for abatacept).
• COYA 302 is administered subcutaneously, and has a dual immunomodulatory mechanism of action intended to reduce neuroinflammation and oxidative stress in ALS.

Active treatment extension period after DB phase (48 weeks)

First three visits 2 weeks apart, then monthly visits with two calls in between

Study procedures:
– Neuromuscular exam
– Outcome measurements for disease progression
– Respiratory function and muscle strength test
– Laboratory: blood and urine samples