Favorable safety results pave the way for Phase 1 human trials in early 2025, offering hope for millions seeking non-addictive pain relief solutions
MIRA Pharmaceuticals (MIRA), a preclinical-stage pharmaceutical company, has announced a critical advancement in its development of Ketamir-2, a novel oral ketamine analog designed to treat neuropathic pain. Recent safety studies affirm the drug’s strong safety profile, enabling the company to progress toward Phase 1 human trials in early 2025.
A Milestone in Neuropathic Pain Drug Development
“This milestone reflects our commitment to advancing Ketamir-2 as a safe and effective treatment for neuropathic pain,” said Erez Aminov, CEO and Chairman of MIRA Pharmaceuticals. “Our focus on safety positions us to attract strategic partnerships or pursue potential mergers and acquisitions as we move forward.”
The findings mark a significant step for MIRA, as safety concerns account for nearly 40% of drug failures during clinical development. By addressing this critical challenge early, the company reduces risk and strengthens its case for regulatory approval.
Preclinical Data Highlights Ketamir-2’s Safety
Comprehensive preclinical studies revealed no significant safety concerns for Ketamir-2 across key physiological systems:
- Cardiovascular Safety: No adverse effects at therapeutic doses in canine studies.
- Central Nervous System (CNS): Favorable outcomes in rats, with no significant changes at therapeutic doses. High-dose effects were limited, transient, and non-disruptive.
- Respiratory Function: No respiratory-related effects in rats, even at higher doses.
- 14-Day Toxicology: Ketamir-2 was well-tolerated at daily doses up to 200 mg/kg in dogs.
- Ames Test: The drug was confirmed as non-mutagenic, underscoring its safe profile.
These results collectively validate Ketamir-2’s potential as a non-addictive alternative for managing neuropathic pain, a condition that affects millions of people worldwide.
The Road to Phase 1 Human Trials
Building on the success of these preclinical studies, MIRA aims to launch its Phase 1 human trials in the first quarter of 2025. These trials will assess Ketamir-2’s safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants.
Notably, the trials will incorporate a battery of pain and psychosis tests, offering valuable insights into the drug’s therapeutic effects. Initial results are anticipated by the second quarter of 2025.
Following Phase 1, the company plans to initiate a Phase IIa proof-of-concept study in late 2025. This study will focus on patients with neuropathic pain, with results expected in early 2026.
Addressing an Urgent Medical Need
Neuropathic pain remains a challenging condition to treat, as many existing therapies carry risks of addiction or intolerable side effects. Ketamir-2’s development represents a potential paradigm shift in managing this condition, offering hope to patients seeking safer, more effective options.
Dr. Itzchak Angel, MIRA’s Chief Scientific Advisor, emphasized the broader implications of this development:
“This is a pivotal moment for both MIRA Pharmaceuticals and the millions of patients who suffer from neuropathic pain. Ketamir-2 holds the promise of being a groundbreaking treatment, addressing a significant unmet medical need with its strong safety profile and potential efficacy.”
Financial and Strategic Strength
MIRA’s financial position further bolsters its ability to achieve clinical milestones. The company is actively exploring non-dilutive funding opportunities to accelerate development and enhance Ketamir-2’s therapeutic impact.
By demonstrating Ketamir-2’s safety and positioning it for clinical success, MIRA not only advances its mission but also strengthens its appeal to potential partners and investors.
MIRA Pharmaceuticals’ progress with Ketamir-2 underscores the company’s commitment to addressing critical gaps in neuropathic pain management. With a strong safety profile validated through rigorous preclinical testing, the company is poised to move confidently into human trials.
As the global demand for non-addictive pain treatments grows, Ketamir-2’s development represents a beacon of hope for millions. MIRA’s innovative approach and strategic focus position it as a leader in this transformative field of medicine.
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