The Fort Worth Press - MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study

MIAMI, FLORIDA / ACCESS Newswire / February 3, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced that it has initiated dosing in the final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating Ketamir-2, its lead oral NMDA receptor antagonist.

To date, 50 healthy volunteers have already been dosed, while dosing in the final cohort is underway, with 6 last subjects remaining. The Company expects to complete the Phase 1 clinical program by the end of the first quarter of 2026.

Phase 1 Progress and Phase 2a Development Plans

The ongoing randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Ketamir-2 in healthy volunteers. Data reviewed to date continue to support advancement of the program, with no serious adverse events reported.

MIRA is actively finalizing its Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN), including clinical site selection, and plans to submit the Phase 2a protocol to the U.S. Food and Drug Administration (FDA) following completion of Phase 1. Subject to regulatory feedback, the Company anticipates initiating the Phase 2a study in the second quarter of 2026.

Given the oncology-related nature of CIPN, the lack of FDA-approved therapies, and the significant unmet medical need, the Company intends to pursue FDA Fast Track designation for Ketamir-2 as the program advances into later-stage clinical development.

Chemotherapy-Induced Peripheral Neuropathy Represents a Significant Unmet Medical Need

Chemotherapy-induced peripheral neuropathy is a common and often debilitating complication of cancer treatment, characterized by chronic nerve pain, tingling, numbness, and burning sensations that may persist long after chemotherapy has ended. CIPN can significantly impair quality of life and frequently limits a patient's ability to tolerate or complete potentially lifesaving cancer therapy.

Despite its prevalence and clinical impact, there are currently no FDA-approved treatments for CIPN. Management typically relies on off-label use of antidepressants, anticonvulsants, opioids, or ketamine-based therapies, which often provide limited benefit and may be associated with tolerability, safety, or practicality challenges. Ketamir-2 was designed to address this unmet need as a differentiated, orally administered NMDA receptor antagonist with the potential to provide effective pain relief without the psychoactive effects or administration limitations associated with ketamine.

Strategic Partnering and Scientific Engagement in 2026

As part of its business development strategy, MIRA announced that it will attend the BIO Partnering Investment & Growth Summit, to be held March 2-3, 2026, in Miami, Florida. The Company plans to engage with large and mid-size pharmaceutical companies to introduce its pipeline and advance potential strategic partnership, collaboration, and merger and acquisition discussions.

In addition, MIRA will be presenting Phase 1 data on Ketamir-2 at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22, 2026, at the San Diego Convention Center in San Diego, California.

Pipeline Update Beyond Ketamir-2

MIRA also provided an update on its additional preclinical programs, SKNY-1 and MIRA-55, both of which are currently undergoing CMC optimization, with the objective of advancing each program into IND-enabling status by year-end 2026.

SKNY-1 is a novel, orally administered small-molecule program being developed for weight loss and nicotine addiction. SKNY-1 was designed as an oral therapy intended to avoid the central nervous system-related adverse effects historically associated with prior CB1 receptor antagonists, as well as the muscle loss that has been reported with certain injectable GLP-1-based therapies. Preclinical studies to date support its continued development as a differentiated metabolic and addiction-focused candidate.

MIRA-55 is a preclinical program being developed for inflammatory pain. In preclinical models, MIRA-55 has demonstrated analgesic activity comparable to injected morphine, along with a significant reduction in inflammation. In these studies, MIRA-55 also demonstrated anti-inflammatory effects that outperformed morphine, supporting its potential as a non-opioid approach to inflammatory pain management.

Management Commentary

"We are pleased to have initiated dosing in the final cohort of our Phase 1 study, marking another important execution milestone for Ketamir-2," said Erez Aminov, Chairman and CEO of MIRA. "As we approach completion of Phase 1 and prepare for Phase 2a development in CIPN, we are increasingly focused on advancing partnering discussions while continuing disciplined, data-driven execution across our pipeline."

Dr. Itzchak Angel, CSA of MIRA, added:

"Chemotherapy-induced neuropathic pain remains an area of profound unmet medical need, with no approved therapies and limited effective options for patients. Ketamir-2 was specifically designed to offer a safer, orally administered alternative that targets key pain pathways without the limitations associated with existing treatments. Advancing this program represents an important step toward improving supportive care for oncology patients."

About Ketamir-2

Ketamir-2 is a proprietary, orally bioavailable new molecular entity designed as a next-generation NMDA receptor antagonist. Preclinical and early clinical data support its potential as an oral, non-opioid therapy for neuropathic pain and related conditions. Ketamir-2 is not classified as a controlled substance under the U.S. Controlled Substances Act.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications with significant unmet medical need.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Krystina Quintana
[email protected]
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

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F.Garcia--TFWP