Rising High: Exclusive talk with pharmaceutical development company MIRA

In this edition of “Rising High,” The Fly conducted an exclusive interview with Erez Aminov, Chairman & Chief Executive Officer of MIRA Pharmaceuticals (MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders. Here are some highlights:

SAFE AND EFFECTIVE: MIRA Pharmaceuticals is advancing two innovative neuroscience programs aimed at addressing a wide range of disorders. The company is currently developing Ketamir-2, a novel non-opioid, oral ketamine analog, and MIRA-55, an oral pharmaceutical marijuana analog.

“Our goal is to create safer, more effective treatments that address critical unmet needs such as neuropathic pain, depression, PTSD, and cognitive decline,” Aminov said. “Preclinical studies with Ketamir-2 have been promising, showing no safety concerns and demonstrating superior efficacy compared to FDA-approved treatments in normalizing neuropathic pain. Additionally, Ketamir-2 has shown significant potential in treating depression, offering a dual-purpose therapeutic benefit.”

MIRA-55 also stands out with its unique attributes, he said. In preclinical models, it has demonstrated its ability to enhance memory and improve cognitive performance while delivering anti-anxiety effects without sedation. “Unlike traditional THC, MIRA-55 combines these benefits without the risks of sedation or cognitive impairment, making it a differentiated and promising option for the treatment of anxiety and cognitive decline,” Aminov noted.
He added these advancements highlight MIRA’s dedication to developing innovative solutions for patients who currently face limited treatment options with significant safety or efficacy challenges.

He highlighted that many treatments on the market have significant safety issues and fail to fully address their intended indications. “Our focus on safety and efficacy truly sets us apart,” he said.

CHALLENGES WITH CURRENT TREATMENTS: “Current treatments for neuropathic pain and depression often come with serious side effects,” Aminov explained. “For example, ketamine, while effective, requires intravenous administration, has a high potential for abuse, and may cause dissociation. Opioids, meanwhile, pose significant risks of addiction, dependency, and overdose.”

He also highlighted the limitations of commonly prescribed depression treatments, such as selective serotonin reuptake inhibitors and other antidepressants. “While SSRIs and similar drugs are widely used, they often take weeks to become effective, have inconsistent efficacy, and can lead to side effects like fatigue, weight gain and sexual dysfunction,” Aminov noted. “These limitations leave many patients with depression under-treated or untreated.”

In addition, pregabalin and gabapentin, which are approved for neuropathic pain, can cause side effects like dizziness, sedation, and cognitive impairment, he said. “In contrast, Ketamir-2 is being developed as an oral, non-opioid, non-addictive, and non-psychoactive treatment that has shown no safety issues in preclinical studies,” Aminov said. “It has demonstrated significant effectiveness in normalizing neuropathic pain, achieving near-complete symptom reversal in preclinical models, while also showing promise in treating depression.”

KETAMIR-2: A DUAL-PURPOSE ORAL ANALOG: Ketamir-2 is under investigation to treat neuropathic pain, treatment-resistant depression, major depressive disorder with suicidal ideation, and PTSD, he said. “We have successfully completed our pre-IND enabling program with no safety issues and submitted our IND application for diabetic neuropathy,” Aminov said. “We plan to initiate Phase 1 studies in humans in the first quarter of this year, followed by a Phase 2a trial in a patient population to establish proof-of-concept by year-end.”

He added the drug’s dual purpose makes it unique. “Preclinical studies show Ketamir-2 is highly effective for both neuropathic pain and depression, which often coexist, particularly in cancer patients undergoing chemotherapy,” Aminov said.

MIRA-55: A NOVEL CANNABIS ANALOG: MIRA-55, the company’s oral pharmaceutical marijuana analog, is being developed for the treatment of anxiety and cognitive decline, often associated with early-stage dementia, he said. “MIRA-55 aims to treat anxiety and improve cognition without THC’s psychoactive effects,” Aminov explained. “Unlike THC, which impairs cognition and carries risks like paranoia and addiction, MIRA-55 enhances memory and cognitive function, as demonstrated in preclinical models.”

ADDRESSING MARKET CHALLENGES: Aminov acknowledged the challenges in the cannabis and psychedelic drug development industries, particularly safety concerns. “We address this by developing compounds like Ketamir-2 and MIRA-55, which combine high efficacy with exceptional safety profiles, suitable even for at-home use,” he said.

SCHEDULING: In August, the U.S. Drug Enforcement Administration announced that it would be holding a hearing on the proposal to reschedule cannabis to Schedule III under the Controlled Substances Act on December 2 but has since delayed the hearing. “The scheduling issue has been a topic of discussion for a long time,” Aminov explained. “Cannabis remains challenging to reschedule due to its many safety concerns, particularly its potential for cognitive impairment, dependency, and other side effects.”

However, MIRA-55 and Ketamir-2 stand apart, as the DEA’s scientific review concluded that both compounds would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations, he said. “This gives us a significant advantage, as it removes many of the regulatory hurdles associated with traditional cannabis-based treatments while offering a safer, more effective alternative,” Aminov said.

Ketamine is also scheduled under the Controlled Substances Act as a Schedule III drug. “Ketamine has been widely used as an anesthetic since the 1960s and has gained significant attention for its therapeutic benefits, particularly in treating depression and neuropathic pain,” Aminov noted. This demand has led to the rapid rise of ketamine clinics across the country, he said. However, ketamine’s potential for abuse, safety concerns, and poor oral bioavailability have limited its broader use, requiring intravenous administration and strict monitoring under Risk Evaluation and Mitigation Strategies protocols, he noted.

“Ketamir-2 has been designed to maintain the therapeutic effects of ketamine in a convenient oral formulation while addressing many of these challenges,” Aminov explained. “By potentially reducing the need for REMS protocols, Ketamir-2 could offer a safer and more accessible alternative for patients seeking effective treatments.”

ELECTION RESULTS: In this year’s U.S. election, Massachusetts voters rejected a ballot measure to decriminalize psychedelic use for adults over 21, reflecting ongoing stigma and safety concerns, he said. “This demonstrates the hesitancy regulators and the public still have around certain compounds due to safety and misuse concerns,” Aminov noted. “By focusing on developing safer, non-psychoactive compounds like Ketamir-2 and MIRA-55, we aim to offer effective solutions that can gain broader acceptance.”

Similarly, states like Florida, North Dakota, and South Dakota rejected measures to legalize recreational cannabis, while Nebraska approved medical cannabis. “The mixed outcomes highlight the pressing need for safer, more controlled alternatives,” Aminov said.

CHALLENGES: When asked about the biggest hurdles facing the cannabis/psychedelic drug development industry, the CEO pointed to safety. “Safety remains the primary challenge, as approximately 30-40% of drugs fail clinical trials due to safety concerns,” Aminov explained. “Addressing these issues requires innovative approaches that balance efficacy with a strong safety profile, which is essential for gaining regulatory and public trust. Without this focus, the industry will continue to struggle with significant setbacks.”

OPPORTUNITES: When asked where he sees the biggest opportunities for companies in the space, Aminov said they lie in replacing risky and ineffective treatments with safer, non-opioid options. “We are excited to lead the shift with innovative therapies like Ketamir-2 and MIRA-55 that address these unmet needs and we feel that we are taking full advantage of these opportunities in the market,” he said. “We are committed to redefining neuropsychiatric treatments with safer, innovative solutions. We believe the future is very exciting and we’re ready to make a meaningful impact on patients’ lives.”

CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Ascend Wellness (AAWH), Atai Life Sciences (ATAI), Aurora Cannabis (ACB), Avant Brands (AVTBF), Ayr Wellness (AYRWF), The Cannabist Company (CBSTF), Cannara Biotech (LOVFF), Canopy Growth (CGC), Cansortium (CNTMF), Chicago Atlantic (REFI), Clearmind (CMND), Clever Leaves (CLVR), Compass Pathways (CMPS), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), Curaleaf (CURLF), CV Sciences (CVSI), Cybin (CYBN), Entourage Health (ETRGF), Enveric Biosciences (ENVB), Flora Growth (FLGC), Trees Corporation (CANN), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Hemp (HEMP), Heritage Cannabis (HERTF), High Tide (HITI), IGC Pharma (IGC), IM Cannabis (IMCC), Innovative Industrial Properties (IIPR), InterCure (INCR), Ispire Technology (ISPR), Lowell Farms (LOWLF), Lucy Scientific Discovery (LSDI), MediPharm (MEDIF), MindMed (MNMD), NewLake Capital (NLCP), Numinus (NUMIF), Optimi Health (OPTHF), Organigram (OGI), PharmAla (MDXXF), Planet 13 (PLNHF), Psyence Biomedical (PBM), Red White & Bloom (RWBYF), Relmada Therapeutics (RLMD), Reunion Neuroscience (REUN), RIV Capital (CNPOF), Safe Harbor Financial (SHFS), SNDL (SNDL), Skye Bioscience (SKYE), Stem Holdings (STMH), TerrAscend (TRSSF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), Verano (VRNOF), Village Farms (VFF), Vireo Health (VREOF) and 4Front Ventures (FFNTF).