Welcome to our dedicated page for Mira Pharma news (Ticker: MIRA), a resource for investors and traders seeking the latest updates and insights on Mira Pharma stock.
Overview
Mira Pharmaceuticals Inc (NASDAQ:MIRA) is a preclinical-stage pharmaceutical development company dedicated to advancing innovative therapies for a wide spectrum of neurological and neuropsychiatric disorders. With a targeted focus on neuroscience, the company is developing two major drug candidates: a novel oral ketamine analog, Ketamir-2, and an oral pharmaceutical marijuana analog, MIRA-55.
Innovative Drug Candidates
Ketamir-2: This oral ketamine analog is engineered to combat neuropathic pain, treatment-resistant depression, and other neuropsychiatric conditions. Its unique mechanism of action focuses on selective inhibition of the NMDA receptor at the PCP-binding site with a reduced affinity compared to traditional ketamine. This selective binding potentially minimizes psychotropic side effects such as dissociation and hallucinations while ensuring improved oral bioavailability and enhanced brain penetration through non-interaction with P-glycoprotein (P-gp).
MIRA-55: The company is also developing an innovative oral formulation of a pharmaceutical marijuana analog aimed at treating neuropathic pain, anxiety, and cognitive decline often seen in early-stage dementia. Its development is supported by rigorous preclinical studies that highlight a favorable safety profile and a potentially improved efficacy compared to traditional compounds in this space.
Scientific and Clinical Focus
Leveraging strong preclinical data, Mira Pharma emphasizes the design and optimization of drug formulations that demonstrate both safety and efficacy. Their research indicates that Ketamir-2, with its exclusive mechanism and elevated bioavailability, could offer a more consistent therapeutic effect at lower doses. The company is also focused on developing improved formulations, such as the Ketamir-2 Pamoate salt, intended to enhance pharmacokinetic profiles and patient compliance.
Regulatory and Developmental Milestones
Mira Pharma’s robust preclinical studies have paved the way toward submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The firm’s strategic roadmap includes planned Phase I clinical trials to evaluate safety, pharmacokinetics, and tolerability in healthy volunteers, followed by proof-of-concept studies in patients suffering from neuropathic pain and other targeted conditions. This structured clinical development approach underlines their commitment to transforming novel preclinical insights into practical, safe treatment options.
Market Position and Competitive Landscape
Operating within the competitive realm of pharmaceutical innovation, Mira Pharma differentiates itself by focusing on non-opioid alternatives and compounds with a cleaner pharmacological profile. Their pioneering approach in developing selective NMDA receptor modulators and leveraging enhanced oral drug delivery mechanisms set them apart from traditional therapies. Although still in the preclinical stage, their work is aimed at addressing significant unmet medical needs in neurological and neuropsychiatric therapy markets.
Research, Expertise, and Future Considerations
Mira Pharma is anchored by a team of experienced researchers and industry veterans who blend deep scientific expertise with strategic regulatory planning. Their rigorous preclinical research underscores a commitment to scientific excellence and the development of safer, more effective treatment modalities. The company’s unbiased and evidence-based approach ensures that each clinical development milestone is built on robust data, reflecting a high degree of authoritativeness and trustworthiness in its scientific communications.
MIRA Pharmaceuticals (NASDAQ:MIRA) has initiated its Phase 1 clinical trial of Ketamir-2, enrolling the first subjects at Hadassah Medical Center in Jerusalem. The trial will evaluate this novel oral ketamine analog for neuropathic pain treatment across 56 subjects in Single and Multiple Ascending Dose cohorts.
Preclinical data showed Ketamir-2's superior efficacy compared to pregabalin and gabapentin, with strong safety profile and oral bioavailability, without ketamine's typical dissociative effects. The Phase 1 study is expected to complete by Q4 2025, followed by a Phase 2a trial in diabetic neuropathic pain patients.
MIRA is also developing a topical Ketamir-2 formulation and advancing the acquisition of SKNY Pharmaceuticals, which includes a $5 million capital infusion. The acquisition brings SKNY-1, a non-GLP-1 oral therapy for weight loss and smoking cessation, into MIRA's pipeline.
MIRA Pharmaceuticals (NASDAQ:MIRA) has signed a binding letter of intent to acquire SKNY Pharmaceuticals, securing a $5 million capital infusion. The acquisition includes SKNY-1, a preclinical-stage oral drug candidate targeting weight loss and smoking cessation.
The transaction will be executed through a stock exchange, with SKNY shareholders receiving MIRA common stock at a valuation determined by an independent third-party firm. The deal positions MIRA in two significant markets: the weight loss drug market, projected to exceed $150 billion by early 2030s, and the smoking cessation market, expected to reach $51 billion by 2030.
SKNY-1 is being developed to interact with cannabinoid receptors CB1 and CB2 pathways for appetite, metabolism, and energy balance regulation. The drug aims to address limitations of current treatments, including severe side effects and the need for lifelong injections in existing weight loss medications.
The transaction is subject to a 90-day due diligence period, regulatory approvals, and board approvals.
MIRA Pharmaceuticals (NASDAQ:MIRA) has successfully developed a topical formulation of Ketamir-2 for localized neuropathic and inflammatory pain treatment, expanding beyond its existing oral formulation. The topical treatment is designed for slow release, providing targeted pain relief while minimizing systemic exposure and side effects.
The new formulation targets multiple conditions including:
- Neuropathic pain conditions (diabetic neuropathy, postherpetic neuralgia)
- Inflammatory pain conditions (osteoarthritis, rheumatoid arthritis)
- Nerve compression & musculoskeletal pain
MIRA's clinical progress includes:
- Ongoing Phase 1 trial for oral Ketamir-2
- Preclinical PTSD studies
- Planned Phase 2a study for diabetic neuropathy by year-end
- Animal study for topical Ketamir-2
- MIRA-55 preclinical studies for memory enhancement
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.
FAQ
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