Mira Pharmaceuticals announces Ketamir-2 manuscript accepted for publication

MIRA Pharmaceuticals (MIRA) announced that the first manuscript describing its lead drug candidate Ketamir-2, currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, has been accepted for publication in the peer-reviewed journal Frontiers in Pharmacology. The article, titled “KETAMIR-2, A NEW MOLECULAR ENTITY AND NOVEL KETAMINE ANALOG,” authored by Itzchak Angel, Ph.D., MIRA’s Chief Scientific Advisor, highlights Ketamir-2’s pharmacological differentiation from ketamine and its potential as a next-generation CNS therapeutic. Acceptance into Frontiers in Pharmacology provides external scientific validation by independent experts, underscoring the rigor and credibility of MIRA’s research. The publication confirms that Ketamir-2 was specifically engineered to overcome limitations associated with ketamine-such as poor oral bioavailability, dissociative side effects, and non-specific receptor binding. Key Highlights from the Publication: Ketamir-2 is a low-affinity NMDA receptor antagonist that selectively targets the NMDA PCP site. Unlike ketamine, Ketamir-2 showed no significant interaction with over 40 other receptors, transporters, or ion channel targets-including dopamine, opioid, serotonin, and monoaminergic systems-highlighting its clean pharmacological profile and reduced off-target effects. In contrast to ketamine, Ketamir-2 did not induce hyperlocomotion in preclinical models-a behavior associated with agitation and schizophrenia-like symptoms-suggesting a favorable neurobehavioral safety profile. In validated behavioral models, Ketamir-2 demonstrated clear anxiolytic and antidepressant-like effects. Ketamine, used as a control, either showed no benefit or limited effect in most tests. All studies were conducted via the oral route. Ketamir-2 was shown to cross the blood-brain barrier and is not a substrate for P-glycoprotein, which often limits oral drug delivery to the brain. This may explain Ketamir-2’s ability to maintain CNS activity despite its lower NMDA receptor affinity. MIRA also announced that its Phase 1 trial of Ketamir-2 is progressing as planned, with no safety concerns reported to date and dose escalation advancing. The Company expects to initiate a Phase 2a clinical trial in neuropathic pain by year-end 2025, pending regulatory clearance. In addition, the Company is preparing new scientific data submissions and presentations to further support Ketamir-2’s clinical development and potential across CNS-related conditions. MIRA also reaffirmed that the acquisition of SKNY Pharmaceuticals, which includes a first-in-class oral CB1/CB2 inverse agonist for obesity and smoking cessation, is progressing on track. The Company has submitted the required regulatory filings for the merger to the U.S. Securities and Exchange Commission.