Research Studies
Study Title
Study of COYA 302 for the Treatment of ALS (ALSTARS)
Enrollment Status
Recruiting
Principal Investigators
Site-PIs: Nathan Carberry, MD; Michael Benatar, MD, PhD
Study Type
Drug Trial
Goals
- 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.
Enrolling
ALS patients
Eligibility
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- 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
Study Involvement
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6 months of double-blind treatment (24 weeks)
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
Primary Funding Source
Coya Therapeutics
Related Publications
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Related Presentations & Lectures
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