Approval Probability
TA Base Rate
Adjusted LOA
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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: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Week 1) and matching placebo (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: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg 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. |
| 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: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg DRL\_AB) (Week 1) and matching placebo (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: COYA 302 (0.10 mg \[1M IU\] LD IL-2 and 125 mg 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. |
| 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 being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in a randomized, double-blind, placebo-controlled trial.
COYA 302 targets IL-2 and CTLA-4 pathways. By modulating these molecular targets, the drug aims to influence immune system regulation, which is relevant to the neurodegenerative processes in ALS. This mechanism is being investigated in a Phase 2 clinical trial for its potential therapeutic effect.
COYA 302 is being developed by Coya Therapeutics, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol COYA. Coya Therapeutics is conducting a Phase 2 clinical trial of COYA 302 in patients with Amyotrophic Lateral Sclerosis (ALS).
COYA 302 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Fast Track designation by the FDA, which is intended to facilitate development and expedite review for serious conditions like ALS.
COYA 302 is being studied in a Phase 2 clinical trial with the identifier NCT07161999. This trial is titled 'Study of COYA 302 for the Treatment of ALS' and is currently recruiting participants. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 120 patients in the United States and Canada.
COYA 302 is the primary name for this investigational drug being developed by Coya Therapeutics. No alternative names have been reported for this compound. It is a small molecule that targets IL-2 and CTLA-4 pathways and is being studied specifically for the treatment of ALS.