MIRA News & Events

MIRA Pharmaceuticals announced results from preclinical studies evaluating the optimized oral formulation of SKNY-1, the Company's oral drug candidate being developed for obesity and addiction-related disorders. The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial liver exposure following oral administration. Peak plasma concentrations were observed approximately six to twelve hours after dosing, supporting the potential for convenient once-daily oral dosing. Collectively, these findings further strengthen the development profile of SKNY-1 by demonstrating that the compound combines meaningful pharmacologic activity observed in previously reported efficacy studies with pharmacokinetic characteristics that support continued development as an orally administered therapeutic. The objective of the study was to optimize the oral formulation of SKNY-1 and evaluate its pharmacokinetic profile, oral bioavailability, and tissue distribution following oral administration. Multiple oral formulations were evaluated in a preclinical pharmacokinetic study to identify an optimized formulation that provides reproducible systemic exposure together with meaningful distribution into pharmacologically relevant target tissues. Importantly, SKNY-1 demonstrated robust brain penetration and substantial liver exposure following oral administration. Detectable tissue exposure was consistently observed across multiple animals, supporting reliable and reproducible distribution into target organs. The simultaneous exposure of both the central nervous system and liver is particularly significant because these organs regulate complementary aspects of appetite, reward signaling, and metabolic homeostasis. Brain penetration may support modulation of neuronal circuits involved in appetite, satiety, and reward-associated behaviors, while liver exposure may contribute to regulation of lipid metabolism, glucose homeostasis, and energy utilization previously observed in preclinical efficacy studies. Importantly, robust brain penetration was achieved while maintaining a differentiated central nervous system profile. As previously reported by the Company, SKNY-1 was devoid of anxiety-related behavior in a validated preclinical cannabinoid behavioral model despite engaging central cannabinoid pathways. These findings distinguish SKNY-1 from earlier CB1-targeting therapies, including rimonabant, which were associated with significant neuropsychiatric adverse effects.

MIRA Pharmaceuticals announced new preclinical pharmacology data on Mira-55, the Company's cannabinoid analog in development for chronic inflammatory pain. Mira-55 is designed to act on the same cannabinoid receptors as compounds found in cannabis, including THC. A central pharmacological question for the program is whether Mira-55 can deliver therapeutic activity through that receptor system without carrying THC's known liabilities, including psychoactivity and central nervous system side effects. This new study addresses that question directly. Using a standard test researchers rely on to characterize THC-like compounds, Mira-55 showed a pharmacological profile that sets it apart from THC, including a meaningful anxiolytic effect that THC does not produce. These findings build on data MIRA reported in March 2026, which showed Mira-55 did not produce THC-like side effects and demonstrated anxiety-reducing activity in animal testing, in contrast to rimonabant, a drug that blocks the same receptor THC acts on. Together, the two studies form a consistent picture: Mira-55 engages the cannabinoid system differently than THC does, and that difference shows up at both the behavioral and mechanistic levels. Researchers tested THC and Mira-55, along with rimonabant's ability to reverse their effects, in the same study using three standard measures scientists use to characterize THC-like activity: body temperature, movement, and muscle rigidity. They also tested for anxiety-like behavior. THC showed the classic pattern of a THC-like compound. It lowered body temperature, slowed movement, and catalepsy- and all three effects went away when rimonabant was given alongside it. That is the textbook signature researchers look for to confirm a compound is acting through the same CB1 pathway as THC. Mira-55 showed a different pattern. It produced only one of those three effects, a modest drop in body temperature, with no effect on movement or rigidity. Mira-55's mechanism looks different, too. Rimonabant did not block Mira-55's effect on body temperature the way it blocked THC's, suggesting Mira-55 is not working through the same mechanism as THC, even in the one area where their effects briefly overlap. Mira-55 produced a meaningful effect; THC did not: it reduced anxiety-like behavior. Rimonabant made animals more anxious in this test; Mira-55 made them less anxious - consistent with what MIRA reported in March, and a distinguishing feature of Mira-55's profile rather than simply an absence of THC-like effects. MIRA is advancing Mira-55 toward IND-enabling studies for chronic inflammatory pain, a large and growing market with significant unmet medical need. Current treatment options include opioids, which carry risks of dependence, tolerance, and overdose, and NSAIDs, which may cause gastrointestinal, renal, and cardiovascular adverse effects.

Mira Pharmaceuticals announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration, FDA, for Ketamir-2, the Company's proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy, XIPN.