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: 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 developed for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in a randomized, double-blind, placebo-controlled trial to evaluate its safety and efficacy in patients with ALS.
COYA 302 is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to treat ALS, a neurodegenerative disease. Clinical trials are ongoing to determine its mechanism of action and therapeutic effects in patients.
COYA 302 is being developed by Coya Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol COYA. The company is conducting a Phase 2 clinical trial of COYA 302 for the treatment of ALS.
COYA 302 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track designation from the FDA, which is intended to expedite the development and review of therapies for serious conditions with unmet medical needs.
COYA 302 is being studied in a Phase 2 clinical trial with the identifier NCT07161999, titled 'Study of COYA 302 for the Treatment of ALS'. This randomized, double-blind, placebo-controlled trial is recruiting 120 participants in the United States and Canada. The trial is currently active and recruiting patients aged 18 years and older.
COYA 302 is a unique investigational drug developed by Coya Therapeutics. No alternative names have been reported for this compound. It is being studied specifically for the treatment of ALS and is not known to be identical to any other approved or investigational therapy.