Recent Updates — MIRA
Mira Pharmaceuticals announced initial proof-of-concept results from an exploratory pilot study of SKNY-1, its investigational oral candidate for obesity. In diet-induced obese mice, the treatment produced statistically significant reductions in body weight and fat mass compared to controls. The data highlighted three differentiating factors versus semaglutide: weight loss occurred without a significant decrease in food intake; lean-mass was preserved rather than lost; and weight regain was slow and limited after discontinuation, contrasting with rapid rebound seen with the reference drug. These findings suggest SKNY-1 may influence metabolic pathways beyond appetite suppression. The company is advancing IND-enabling activities to support future clinical development. Mira Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel oral small-molecule therapeutics for pain and obesity.
Mira Pharmaceuticals announced positive results from a 21-day IND-enabling preclinical proof-of-concept study evaluating oral MIRA-55 in a validated model of chronic inflammatory pain. The study demonstrated that once-daily oral MIRA-55 significantly reduced mechanical and thermal pain hypersensitivity compared with vehicle-treated animals (p < 0.001). Pain-relieving effects were comparable in magnitude to celecoxib, a widely prescribed medication for pain and inflammation. Effects were sustained throughout the three-week study without evidence of tolerance or adverse clinical signs. MIRA-55 also reduced inflammation-associated paw swelling to a similar magnitude as celecoxib and demonstrated consistent activity in both male and female animals. These findings support the company's plan to submit an Investigational New Drug application in the first quarter of 2027. Mira Pharmaceuticals is a clinical-stage pharmaceutical company developing novel oral therapies for neurologic, inflammatory and metabolic disorders.
MIRA Pharmaceuticals announced that its Phase 2a clinical program for Ketamir-2 in chemotherapy-induced peripheral neuropathy has advanced toward site initiation following FDA review. The company incorporated regulatory feedback into the protocol, which is now under Institutional Review Board review at a leading cancer research institution. Site initiation is targeted for the first quarter of 2027. MIRA Pharmaceuticals operates as a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics.