SanaCurrents on COYA Thera's Treg approach to treat ALS | $COYA
SUMMARY
Last year’s FDA decision to approve Amylyx Pharmaceuticals, Inc.’s (NASDAQ:AMLX) Relyvrio (sodium phenylbutyrate and taurursodiol) to treat amyotrophic lateral sclerosis (ALS) met with controversy, primarily because scientists questioned the overall cost-benefit of the treatment. The controversy did not end despite approvals in the US and Canada. In June 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said clinical testing of Relyvrio did not “convincingly” demonstrate it slowed the worsening of ALS, signaling the drug may not gain approval in Europe.
Despite the potential setback for Relyvrio in Europe, ALS patients and families received a surprise this month. The FDA granted accelerated approval to tofersen, a drug designed to treat ALS patients with a mutation in the SOD1 gene. Biogen, Inc. (NASDAQ:BIIB) and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) developed tofersen, and the drug will be sold under the brand name Qalsody. While tofersen will reach only a small percentage of ALS patients, its approval signals the FDA likely will continue to support new ALS treatments, even if they offer only modest benefit.
COYA Therapeutics, Inc.’s (NASDAQ:COYA) is advancing its ALS drug, COYA 302, to provide a more upstream approach to treating ALS. COYA 302 combines Abatacept and low-dose interleukin-2 (IL-2). COYA expects to release biomarker data in the second half of 2023 that will identify the ALS patients most likely to benefit from COYA 302.
Next Key catalysts
Release of blood biomarker data to develop COYA 302 to treat Amyotrophic Lateral Sclerosis (ALS)
Key catalyst dates
2H 2023