MIRA Pharmaceuticals Inc（MIRA）资讯与事件MIRAMIRA Pharmaceuticals Inc

Mira Pharmaceuticals Announces Positive Initial Results for SKNY-1

Mira Pharmaceuticals announced initial positive proof-of-concept results from an exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders. Conducted in an established diet-induced obesity mouse model, the study demonstrated statistically significant reductions in body weight and fat mass following oral administration of SKNY-1 compared with vehicle-treated controls. Weight reduction occurred without a statistically significant decrease in food consumption, raising the possibility that SKNY-1 may influence metabolic pathways beyond appetite suppression. The study also identified three potentially meaningful areas of differentiation from the semaglutide reference group: effects on food intake, lean-mass outcomes, and weight regain following treatment discontinuation. At the Day 14 body-composition assessment, oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass loss relative to vehicle controls. In contrast, semaglutide-treated mice demonstrated statistically significant lean-mass loss compared with vehicle-treated controls. During the two-week observation period following treatment cessation, oral SKNY-1-treated mice demonstrated slow and limited weight regain. In contrast, semaglutide-treated mice experienced rapid and substantial weight rebound. "Obesity represents one of the largest and fastest-growing opportunities in healthcare, with the potential for multiple multibillion-dollar therapies. We believe the future of obesity treatment will extend beyond a single class of drugs. Patients have different needs, and there is tremendous opportunity for innovative therapies that work through distinct mechanisms and offer favorable profiles for long-term weight management. What makes SKNY-1 particularly exciting is that our findings point toward a potentially differentiated metabolic approach, with encouraging signals regarding body composition and weight maintenance following treatment discontinuation. We believe these characteristics could become important advantages as we continue advancing SKNY-1, positioning it as a potentially valuable asset within our pipeline and an opportunity to participate in this significant global market," said Erez Aminov, CEO of Mira Pharmaceuticals.

Mira Pharmaceuticals Reports Positive Preclinical Results for MIRA-55

Mira Pharmaceuticals announced positive results from a 21-day 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 both mechanical and thermal pain hypersensitivity, p less than 0.001 versus vehicle, as from the lowest dose used. MIRA-55 achieved pain-relieving effects comparable in magnitude to celecoxib, or Celebrex, at the higher doses evaluated. The effects were maintained throughout the three-week study without evidence of tolerance. MIRA-55 also reduced inflammation-associated swelling and was well tolerated, with no adverse clinical signs observed during repeated daily administration. The study included 72 male and female rats. MIRA is advancing MIRA-55 toward a planned Investigational New Drug submission in Q1 2027. "With Ketamir-2 advancing toward Phase 2 clinical development for neuropathic pain and MIRA-55 progressing toward an IND for inflammatory pain, we are creating a pipeline of oral therapies targeting distinct but complementary areas of pain," said Erez Aminov, chairman and CEO.

Mira Pharmaceuticals Submits Ketamir-2 Clinical Trial Application, Aiming for 2027 Start

Mira Pharmaceuticals announced that, following review and comments from the FDA, the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy has been submitted for Institutional Review Board, or IRB, review at a cancer research institution. Mira incorporated the FDA's feedback into the protocol and is targeting site initiation in the first quarter of 2027, subject to completion of IRB review and other routine site activation requirements. The study represents Ketamir-2's first clinical evaluation in patients with CIPN and is designed to generate initial efficacy and dose-response data while further characterizing safety and tolerability.