MIRA Pharmaceuticals, Inc. develops oral small-molecule therapeutics for neurologic, neuropsychiatric, metabolic and inflammatory disorders. Recurring company news centers on Ketamir-2, a selective oral NMDA receptor modulator studied for neuropathic pain, including chemotherapy-induced peripheral neuropathy, and on clinical safety, tolerability and pharmacokinetic findings from Phase 1 testing.
Updates also cover Mira-55, a cannabinoid analog designed to modulate CB1 and CB2 receptor activity while limiting central nervous system side effects, with preclinical work in inflammatory pain. Following the completed acquisition of SKNY Pharmaceuticals, MIRA’s pipeline also includes SKNY-1 for obesity and nicotine addiction. Company announcements additionally address shareholder voting matters, operating and financial results, capital actions and other corporate developments.
MIRA Pharmaceuticals (NASDAQ:MIRA) has received approval to initiate Phase 1 clinical trials for Ketamir-2, their novel oral ketamine analog for neuropathic pain treatment. The trial, authorized by the Israeli Ministry of Health, will be conducted at Hadassah Medical Center in Jerusalem.
The study includes two parts: a Single Ascending Dose (SAD) with 32 participants and Multiple Ascending Dose (MAD) with 24 participants. The trial aims to evaluate safety, tolerability, and pharmacokinetics, with completion expected by Q4 2025.
Preclinical studies showed Ketamir-2's superior efficacy compared to existing treatments:
- Full pain reversal in nerve ligation models
- 60% more effective than gabapentin in chemotherapy-induced neuropathy
- Enhanced bioavailability through Pamoate salt formulation
- Improved safety profile with no cardiovascular concerns
The neuropathic pain market is projected to reach $5.2 billion in North America by 2030. The company plans to initiate Phase 2a studies in Q4 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) has submitted an Investigational New Drug (IND) application to the FDA for Ketamir-2, its novel oral ketamine analog for treating neuropathic pain. The submission includes comprehensive data on pharmacology, pharmacokinetics, and toxicology, along with in vitro and in vivo study results.
The North American neuropathic pain market is valued at $3.1 billion with expected growth to $4.5 billion by 2030. Ketamir-2 addresses limitations of existing treatments through selective NMDA receptor targeting, showing 100% pain reversal in preclinical studies without psychotropic effects. The company plans to initiate Phase I Clinical Trials in Q1 2025, followed by Phase IIa trials in late 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) announces successful completion of Good Laboratory Practice preclinical safety program for Ketamir-2, their novel oral ketamine analog. The studies showed no adverse findings across multiple safety assessments, including cardiovascular safety in dogs, CNS assessment in rats, and respiratory safety tests.
The company plans to submit an Investigational New Drug (IND) application by end of 2024, with Phase I clinical trials scheduled to begin in Q1 2025. The trial design includes pain tests to evaluate effects on neuropathic pain and psychosis, with data expected by Q2 2025. A Phase IIa proof-of-concept study is planned for Q4 2025, with results anticipated by year-end.
MIRA Pharmaceuticals (NASDAQ:MIRA) has selected The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. The trial will begin recruitment in Q1 2025, with Phase I results expected in H2 2025 and Phase IIa results in H1 2026. The study will utilize CHDR's proprietary PainCart technology to measure pain response in healthy subjects during Phase I, followed by testing in diabetic neuropathy patients in Phase IIa. The trial is designed as a randomized, double-blind, placebo-controlled study. Ketamir-2 has shown superior efficacy compared to pregabalin and gabapentin in preclinical studies, with no reported side effects to date.
MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog Ketamir-2 shows 60% greater efficacy than FDA-approved gabapentin in treating chemotherapy-induced neuropathic pain in preclinical studies. Using the paclitaxel model, Ketamir-2 achieved near-complete pain normalization at 300 mg/kg dose. The company plans to submit an IND application by end of 2024 and begin Phase I trials in Q1 2025. MIRA is also evaluating Ketamir-2 for diabetic neuropathy, PTSD, and other conditions. The drug could potentially qualify for FDA breakthrough therapy designation, fast track, and priority review for treating rare cancer-related neuropathic pain.
MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog, Ketamir-2, outperforms FDA-approved neuropathic pain treatments Gabapentin and Pregabalin in preclinical studies. Key findings show Ketamir-2 provided up to 112% more effective results than Pregabalin and 70% greater relief than Gabapentin at higher doses by Day 22 in female rats.
Ketamir-2 offers advantages over current treatments, including being non-habit forming and potentially avoiding sedation and cognitive impairment. MIRA is preparing to submit an Investigational New Drug (IND) application by year-end, with Phase 1 clinical trials scheduled for Q1 2025 and Phase 2 trials in Q4 2025. The company is also exploring Ketamir-2's potential for PTSD treatment and pursuing government grants to accelerate development.
MIRA Pharmaceuticals (NASDAQ:MIRA) announced new preclinical data on Ketamir-2, its lead development product, will be presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024. The presentation, titled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase breakthrough findings where Ketamir-2 achieved 100% reversal of neuropathic pain in preclinical models.
Ketamir-2, a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine. In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 demonstrated superior efficacy to ketamine, achieving full normalization of pain response. MIRA plans to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024, with aims to demonstrate efficacy in humans as early as 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced significant progress in the clinical development of its novel oral ketamine analog, Ketamir-2. The company has initiated drug product development in collaboration with Formulex, focusing on spray-dry based granulation in capsules. MIRA is on track for its Investigational New Drug (IND) filing with the FDA in December 2024. The company aims to demonstrate clinical efficacy for neuropathic pain as early as 2025 through innovative Phase I/II study designs. MIRA has finalized its Phase I clinical trial design, set to begin in early Q1 2025, assessing safety, tolerability, and pharmacokinetics in humans. The company is also exploring additional indications in mental health, including Major Depressive Disorder with Suicidal Ideation, Treatment-Resistant Depression, and Post-Traumatic Stress Disorder.
MIRA Pharmaceuticals (NASDAQ:MIRA) has chosen neuropathic pain as the primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a pre-IND meeting request to the FDA, expected in November 2024. MIRA aims to submit its IND by year-end, with human trials anticipated in Q1 2025.
Ketamir-2 is designed to offer enhanced therapeutic efficacy, improved oral bioavailability, and a superior safety profile compared to existing treatments. It's a non-opioid, non-controlled substance, potentially offering safer and more accessible pain relief. The North American neuropathic pain market is projected to reach $5.2 billion by 2030, driven by an aging population and increasing prevalence of conditions like diabetes.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced a breakthrough in neuropathic pain treatment. Their novel oral ketamine analog, Ketamir-2, achieved 100% reversal of neuropathic pain in a pre-clinical rat study, outperforming traditional oral ketamine. Key findings include:
- Low doses led to significant pain reversal for 14-22 days post-operation
- Higher doses completely normalized pain thresholds
- Ketamir-2 showed superior efficacy compared to oral ketamine
- Additional studies are underway for cancer-induced depression and neuropathic pain
- Human efficacy could potentially be demonstrated as early as 2025
MIRA is now focusing on scaling production and preparing for clinical trials, positioning Ketamir-2 as a potential game-changer in neuropathic pain treatment.