Mira Pharmaceuticals announces key drug development milestone

Mira Pharmaceuticals , Inc. (NASDAQ:MIRA), a $14.46 million market cap pharmaceutical company, reported today a significant advancement in its drug development program. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.99, indicating robust short-term financial health. The company’s novel topical formulation of Ketamir-2 has shown successful and dose-proportional drug release in a validated laboratory study, marking a pivotal step towards clinical trials.

This development is particularly noteworthy as many water-soluble compounds struggle to be effectively delivered through topical creams due to formulation challenges. Mira’s breakthrough suggests that its topical Ketamir-2 could offer a reliable non-opioid pain treatment option, complementing the oral formulation currently undergoing Phase 1 trials.

Erez Aminov, Chairman and CEO of Mira, highlighted the strategic importance of this milestone, stating, "With both oral and topical path now in motion, we’re targeting a much broader market and moving closer to providing multiple therapeutic options to address the growing burden of pain."

Mira is initiating preclinical efficacy studies to determine if the topical formulation can effectively treat inflammatory and neuropathic pain. These studies will inform potential clinical development paths.

The company is also exploring the possibility of Fast Track designation for the topical Ketamir-2 program under the FDA’s expedited development program, which could hasten the process towards human studies if granted.

The significance of this development is underscored by the market potential it targets. The U.S. topical pain relief market is anticipated to surpass $11.5 billion by 2025, with growing demand for localized, non-opioid treatments that reduce systemic exposure. Mira’s dual-route strategy with Ketamir-2 positions it to potentially tap into both systemic and topical treatment markets. While analysts have set an ambitious price target of $17.75, InvestingPro analysis suggests the stock is currently undervalued, despite recent challenges reflected in its -24.55% year-to-date return.

Mira’s oral Ketamir-2 formulation is currently in Phase 1 clinical trials, with a Phase 2a trial for diabetic neuropathy expected to begin later this year.

This report is based on a press release statement.

In other recent news, MIRA Pharmaceuticals has announced positive findings from a preclinical study of its drug candidate, Ketamir-2, which showed a significant reduction in neuropathic pain symptoms in an animal model of diabetic neuropathy. The company has commenced a Phase 1 clinical trial for Ketamir-2, aiming to treat neuropathic pain, with the first participants enrolled in Israel. MIRA Pharmaceuticals is also facing a Nasdaq delisting notice due to not meeting the minimum stockholders’ equity requirement, though it is actively working on a compliance plan. Part of this plan includes the acquisition of SKNY Pharmaceuticals, which is expected to bring a $5 million capital infusion to bolster MIRA’s balance sheet. This acquisition will also expand MIRA’s pipeline with SKNY-1, a drug candidate targeting obesity and smoking cessation. MIRA emphasizes the potential of Ketamir-2 as a non-opioid alternative for diabetic neuropathy, with plans to advance to a Phase IIa trial by late 2025. The company remains focused on its neuroscience pipeline and regulatory milestones. MIRA’s strategic moves aim to maintain its Nasdaq listing and enhance long-term shareholder value.

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