Mira Pharma Stock Price, News & Analysis

MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive in vitro release testing (IVRT) results for its topical Ketamir-2 formulation, targeting the $11.5B U.S. topical pain relief market. The 5% ointment formulation demonstrated consistent and dose-proportional release in Franz diffusion cell model testing.

The company is advancing preclinical studies to evaluate the topical formulation for inflammatory and neuropathic pain conditions. The development aims to address chronic pain affecting 51.6 million U.S. adults, including osteoarthritis (32.5 million adults) and diabetic peripheral neuropathy (28% of diabetic adults).

MIRA is exploring FDA Fast Track designation possibilities and is simultaneously conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers, with plans for a Phase 2a study in diabetic neuropathy.

MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive results for its oral ketamine analog Ketamir-2 in a diabetic neuropathy animal model. The study demonstrated significant reduction in neuropathic pain symptoms, with some subjects achieving complete reversal to pre-diabetic baseline sensitivity.

The company is currently conducting a Phase I clinical trial at Hadassah Medical Center, with completion expected in Q4 2025. MIRA plans to initiate a Phase IIa trial in diabetic neuropathy patients by year-end, with first human efficacy data expected in H1 2026.

Ketamir-2 has shown superior performance compared to FDA-approved medications like pregabalin and gabapentin in preclinical studies. Unlike traditional ketamine, it doesn't cause dissociative effects and offers better blood-brain barrier penetration. The company is also developing a topical slow-release formulation and exploring applications for PTSD treatment.

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.