MIRA PHARMACEUTICALS INC. Aktie

MIRA Pharmaceuticals has completed exploratory, non‑GLP-compliant 7-day toxicology and toxicokinetic repeat-dose studies for the drug candidates MIRA-55 and SKNY-1 in rats and dogs. Sample analyses, toxicokinetic evaluation and histopathology are still ongoing. MIRA-55 is being developed orally for chronic inflammatory pain, SKNY-1 for obesity and addictive disorders; both programs have also advanced through CMC and formulation optimization. The results are intended to inform study design and dose selection for future GLP-compliant, IND‑relevant studies. » Altro su de.investing.com

MIRA Pharmaceuticals has selected a lead oral formulation of MIRA-55 in preclinical studies that showed systemic bioavailability after oral dosing and distribution into brain and liver tissue. The tissue exposure could modulate central pain-processing pathways and support peripheral anti-inflammatory effects; the DEA does not classify MIRA-55 as a controlled substance. The stock is trading near its 52-week low; the company is unprofitable but has more cash than debt and a market capitalization of $38.66 million. » Altro su de.investing.com

Mira Pharmaceuticals’ stock rose 5.1% in pre-market trading after positive results from the randomized, double‑blind Phase‑1 study of Ketamir‑2. Safety, tolerability and pharmacokinetics were evaluated in 57 healthy volunteers; there were no serious adverse events and no dose‑limiting toxicities. Analysis showed rapid oral absorption, dose‑proportional Cmax and a half‑life of about 2.5–7 hours (metabolite 7–9 hours), suggesting once‑daily dosing may be feasible. Based on the data, Mira is preparing to submit the Phase‑2a protocol to the FDA, planning a proof‑of‑concept study in chemotherapy‑induced peripheral neuropathy. » Altro su de.investing.com