MIRA Pharmaceuticals has announced positive preclinical data demonstrating that its proprietary non-psychotropic marijuana analog, Mira-55, delivered morphine-comparable pain relief in a validated model of inflammatory pain without causing local inflammation. The clinical-stage pharmaceutical company's findings represent a significant advancement in developing non-opioid alternatives for pain management.
Selective Cannabinoid Receptor Targeting
Mira-55 is engineered as a next-generation analog of marijuana designed to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, thereby reducing the risk of euphoria, sedation, and pro-inflammatory side effects.
"These results reinforce the value of Mira-55 as a differentiated cannabinoid-based therapy with real clinical potential," said Erez Aminov, Chairman and CEO of MIRA. "We believe the drug's ability to match morphine's pain relief—without the baggage of addiction, sedation, or THC-like effects—makes Mira-55 an ideal candidate for large, underserved inflammatory pain markets."
Preclinical Study Results
The compound was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat's paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume.
Key findings from the study showed that Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline levels. The analgesic effect was equivalent to morphine, the standard opioid comparator in the study. Importantly, no sedation or inflammatory swelling was observed with Mira-55 treatment.
Regulatory Advantage
Following a scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. This designation supports the compound's long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development.
The results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation, further validating Mira-55's selective pharmacological profile.
"Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Its novel structure and unique profile with CB2 selectivity and non-scheduled DEA status make it a compelling candidate for treating inflammation-driven pain conditions that are poorly managed by today's standards."
Complementary Pain Portfolio Strategy
Mira-55 complements Ketamir-2, MIRA's clinical-stage NMDA receptor antagonist, which is advancing through Phase 1 development for neuropathic pain. While Ketamir-2 addresses nerve-related pain through central mechanisms, Mira-55 targets inflammatory pain through the endocannabinoid system. Together, they represent two mechanistically distinct, non-opioid approaches to treating chronic pain.
"With Mira-55 and Ketamir-2, we now have two highly differentiated drug candidates with the potential to transform how inflammatory and neuropathic conditions are treated," added Aminov. "We're advancing each asset methodically, and we're energized by the momentum we've built across the pipeline."
Development Timeline
MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs—Mira-55 and Ketamir-2—toward their next regulatory and clinical milestones.
The company also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings. The U.S. Securities and Exchange Commission has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval.
