MIRA Pharmaceuticals advances MIRA-55 and SKNY-1 toward IND studies
MIRA Pharmaceuticals has announced progress across two preclinical small-molecule programmes, MIRA-55 for chronic inflammatory pain and SKNY-1 for obesity and addiction-related disorders, with both candidates completing key early-stage development activities ahead of formal IND-enabling studies.
The Miami-based NASDAQ-listed company said it has finished the in-life dosing and scheduled necropsy phases of exploratory, non-GLP, seven-day repeated-dose toxicology and toxicokinetic studies in Sprague Dawley rats and Beagle dogs for both candidates. Sample analysis, toxicokinetic evaluation and histopathology remain under way. The studies are designed to inform tolerability, systemic exposure and dose-selection parameters ahead of the full GLP-compliant toxicology package required for an IND submission.
In parallel, the company said it has advanced chemistry, manufacturing and controls work, including analytical, formulation and manufacturing development activities, to underpin future GLP studies and eventual clinical development.
The programmes in brief
MIRA-55 is a selective cannabinoid CB2 receptor agonist. In previously reported preclinical studies, oral administration normalised pain and reduced inflammation in a validated model, reportedly outperforming injected morphine, without the central nervous system effects associated with THC. The US Drug Enforcement Administration has determined the compound is not a controlled substance, removing a potential regulatory hurdle that has historically complicated cannabinoid-adjacent development.
SKNY-1 targets both obesity and addictive behaviours through central cannabinoid pathways. Peer-reviewed preclinical data published in the International Journal of Molecular Sciences showed dose-dependent body weight reductions, lipid normalisation and reduced hepatic triglyceride accumulation, alongside attenuation of compulsive feeding and nicotine-seeking behaviours in animal models. The compound was said to be devoid of anxiety-related effects, distinguishing it from earlier CB1-targeted agents that were withdrawn from the market over psychiatric safety concerns.
Chief executive Erez Aminov said the parallel progression of formulation, CMC, manufacturing and exploratory toxicology "reflects the disciplined execution of our development strategy." Chief scientific advisor Itzchak Angel noted that the exploratory studies are intended to support the design of "appropriately structured GLP toxicology studies."
Market context and competitive landscape
Both therapeutic areas carry considerable commercial interest but are also crowded. In pain, the non-opioid segment has attracted renewed attention following the opioid crisis, with several companies pursuing CB2-selective, Nav channel and other non-addictive mechanisms. The FDA has signalled supportive intent for non-opioid analgesics, and the Opioid Crisis Response Act framework continues to shape agency interactions in this space.
In obesity, the GLP-1 receptor agonist class has reshaped commercial expectations dramatically, with injectable semaglutide and tirzepatide generating substantial revenues and raising the bar for any new entrant. Oral small-molecule alternatives remain highly sought after, as compliance and cost remain barriers to injectable therapy at scale. SKNY-1's claimed differentiation lies in its dual action on metabolic and addictive behaviours, but the compound remains at a very early stage, and that profile will need to survive controlled human studies before meaningful comparisons with the GLP-1 class are possible.
MIRA's third asset, Ketamir-2, has already completed a Phase 1 study for chemotherapy-induced peripheral neuropathy under an active IND, providing the company with some regulatory experience it can apply to the two earlier-stage programmes. Investors will be watching for the completion of toxicokinetic analysis and histopathology readouts as the immediate next milestones, followed by the commencement of formal GLP toxicology studies that will define the IND timeline for both candidates.