Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
COYA 302 · 1 trial · 1 indication
The ALSFRS-R is an ordinal rating scale used to determine a participant's subjective assessment of their capability and independence with 12 functional activities. The maximal score is 48.
| Arm | Type | Description |
|---|---|---|
| DB: COYA 302 Regimen 1 | EXPERIMENTAL | Regimen 1: 125 mg DRL\_AB and Placebo LD rhIL-2 on Week 1, and LD rhIL-2 (0.10 mg \[1M IU\]) and Placebo DRL\_AB on Week 3 administered via subcutaneous (SC) injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| DB: COYA 302 Regimen 2 | EXPERIMENTAL | Regimen 2: 0.10 mg (1M IU) LD rhIL-2 and 125 mg DRL\_AB on both Weeks 1 and 3 administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| DB: Placebo | PLACEBO_COMPARATOR | Placebo LD IL-2 and Placebo DRL\_AB (Weeks 1 and 3) administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| EXT: Regimen 1 | EXPERIMENTAL | Regimen 1: 125 mg DRL\_AB and Placebo LD rhIL-2 on Week 1, and LD rhIL-2 (0.10 mg \[1M IU\]) and Placebo DRL\_AB on Week 3 administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| EXT: Regimen 2 | EXPERIMENTAL | Regimen 2: 0.10 mg (1M IU) LD rhIL-2 and 125 mg DRL\_AB on both Weeks 1 and 3 administered via SC injection for 5 consecutive days every other week. This dosing regimen will be repeated until completing 6 (six) 4-week cycles, for a total of 24 weeks. |
| Name | Type | Description |
|---|---|---|
| COYA 302 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: 1. Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria 2. Male or female participants aged 18 to 80 3. Time since onset of ALS symptoms ≤28 months from Screening. 4. ALSFRS-R total ...
COYA 302 is an investigational small molecule therapeutic being developed by Coya Therapeutics, Inc. for the treatment of amyotrophic lateral sclerosis (ALS). It is currently in Phase 2 clinical development and has received a Fast Track designation from the FDA. It is not yet approved for commercial use.
COYA 302 is being studied as a treatment for amyotrophic lateral sclerosis (ALS), a progressive neurological disease. The Phase 2 trial is evaluating the drug in adults with ALS across sites in the United States and Canada. It remains investigational and has not been approved for any indication.
COYA 302 targets the IL-2 and CTLA-4 pathways. By engaging both targets, the therapy is designed to modulate immune regulatory function, which is the proposed mechanism under investigation in ALS. The drug is a small molecule and is being studied in a Phase 2 clinical program.
COYA 302 is being developed by Coya Therapeutics, Inc., a biotechnology company that trades under the ticker COYA. The company is sponsoring the Phase 2 clinical trial of the drug in amyotrophic lateral sclerosis. No partnership or licensing arrangement for COYA 302 has been disclosed.
COYA 302 is in Phase 2 clinical development. The ongoing trial is a randomized, double-blind, placebo-controlled study in amyotrophic lateral sclerosis. The drug has received a Fast Track designation from the FDA, but it is investigational and has not been approved for marketing.
COYA 302 is being evaluated in one active Phase 2 trial, NCT07161999, titled Study of COYA 302 for the Treatment of ALS. The trial is active but not recruiting, has an enrollment of 120 participants, and is being conducted in the United States and Canada.