Ketamir-2 / MIRA Pharma, Miralogx - LARVOL DELTA

Oral administration of Ketamir-2, a novel ketamine analog, attenuates neuropathic pain in rodent models via selective NMDA antagonism. (PubMed, Front Pharmacol) - "These tests included the Chung spinal nerve ligation model in rats and mechanical allodynia in a paclitaxel (PTX)-induced neuropathy model in mice. Ketamir-2, administered orally as the pamoate salt, showed significant effects in both tests at variable doses. In these models, it was more effective than orally administered ketamine, pregabalin, or gabapentin, which were used as a positive control."

Journal • Preclinical • Neuralgia • Pain

MIRA Pharmaceuticals Announces FDA Clearance of IND for Ketamir-2, Enabling U.S. Clinical Trials in Neuropathic Pain (ACCESS Newswire) - "MIRA Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Ketamir-2, a novel oral NMDA receptor antagonist for the treatment of neuropathic pain....The Company is now preparing to initiate the Multiple Ascending Dose (MAD) portion of the study, which will assess the safety, tolerability, and pharmacokinetics of repeated dosing over several days. These data will help inform optimal dosing strategies as MIRA moves toward a Phase 2a study, with the goal of initiating its first U.S.-based efficacy trial in Q4 2025....In parallel, the Company is: In discussions with a leading U.S. institution to explore a dedicated trial in chemotherapy-induced peripheral neuropathy (CIPN); Evaluating a Phase 2a study in diabetic peripheral neuropathy (DPN), a large, underserved indication with rising prevalence; Advancing formulation development for topical Ketamir-2 for localized pain applications."

IND • New P2a trial • Diabetic Neuropathy • Pain

KETAMIR-2, a new molecular entity and novel ketamine analog. (PubMed, Front Pharmacol) - "These tests included the Open Field test (OFT), Elevated Plus Maze (EPM), and Forced Swimming Test (FST); all of which are commonly employed behavioral assays used to evaluate the efficacy of anxiety and depression medications. While showing significant effects in these tests at variable doses, ketamine, which was used as a positive control, did not differ from vehicle treatment or showed an opposite response to Ketamir in the majority of the tests studied."

Journal • CNS Disorders • Depression • Mood Disorders • Neuralgia • Pain • Psychiatry • Psychomotor Agitation • Schizophrenia

MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain (ACCESSWIRE) - "MIRA Pharmaceuticals...announced the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the Company's novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1 2025. The study has received authorization from the Israeli Ministry of Health and the Institutional Review Board (IRB) and will be conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel. This Phase 1, randomized, double-blind, placebo-controlled, single-center study is designed to evaluate the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy adult volunteers....The Company expects Phase 1 to conclude by Q4 2025, paving the way for a Phase 2a study in neuropathic pain patients to be initiated by the end of the year."

New P2a trial • Trial status • Central Neuropathic Pain • Peripheral Neuropathic Pain

MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024 (ACCESSWIRE) - "MIRA Pharmaceuticals...announced that new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit...The presentation...will showcase the breakthrough finding that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models....In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 given orally, demonstrated superior efficacy compared to ketamine, achieving 100% reversal of pain responses, representing a full normalization of the response....The company remains on track to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024, with plans to demonstrate an efficacy signal in humans as early as 2025."

IND • Preclinical • Pain

MIRA Pharmaceuticals in Discussions with Memorial Sloan Kettering to Collaborate on Preclinical Cancer Pain Model Utilizing The Company’s Novel Oral Ketamine Analog (PRNewswire) - "MIRA Pharmaceuticals, Inc...announced it is in advanced discussions with Memorial Sloan Kettering Cancer Center (MSK) to initiate a preclinical study evaluating MIRA's novel oral ketamine analog, Ketamir-2, for the treatment of cancer-related pain and depression...This collaboration with MSK, one of the top cancer centers in the world, would represent an important validation of the potential for Ketamir-2. This underscores MIRA's commitment to broadening the potential uses of its novel compound beyond treatment-resistant depression, major depressive disorder, and post-traumatic stress disorder, which MIRA is already studying in a preclinical setting...Successful outcomes from the preclinical study could potentially accelerate the pathway for U.S. Food and Drug Administration approval of an Investigational New Drug Application for Ketamir-2 over the next year..."

IND • Licensing / partnership • CNS Disorders • Oncology • Pain