Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings

MIAMI, FLORIDA / ACCESS Newswire / March 4, 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 completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the Company's proprietary selective oral NMDA receptor modulator.

The randomized, double-blind, placebo-controlled study enrolled 56 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed.

Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway.

Phase 1 data have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting.

Phase 1 Clinical Overview

The study was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel, and was designed to characterize the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2.

Study Design

Randomized, double-blind, placebo-controlled
SAD: Four dose cohorts (50 mg to 600 mg), 32 participants
MAD: Three cohorts (150 mg, 300 mg, 600 mg daily for five days), 24 participants
Study Endpoints: Safety, tolerability, pharmacokinetics

Central nervous system safety was prospectively evaluated using validated clinical instruments, including the Columbia-Suicide Severity Rating Scale (C-SSRS), Bowdle Visual Analogue Scale (VAS), and the Ketamine Side Effect Tool (KSET), to assess dissociative, perceptual, or mood-related effects.

Targeting a High-Unmet-Need Indication: Chemotherapy-Induced Peripheral Neuropathy (CIPN)

MIRA intends to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active IND in the first half of 2026, targeting patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).

CIPN is a debilitating and often dose-limiting complication of cancer treatment. There are currently no FDA-approved therapies specifically indicated for this condition, and management typically relies on off-label agents or intravenous ketamine.

The global chemotherapy-induced peripheral neuropathy market is projected to reach approximately $1.7 billion by 2035, according to Spherical Insights & Consulting (Chemotherapy-Induced Peripheral Neuropathy Market Report, 2024), driven by increasing cancer survivorship and expanded use of neurotoxic chemotherapy regimens.

Ketamir-2: A Differentiated Selective Oral NMDA Receptor Modulator

Ketamir-2 is a proprietary, orally bioavailable new molecular entity designed to selectively modulate the NMDA receptor (PCP binding site) with low binding affinity and minimal off-target receptor activity.

Key attributes include:

Oral administration with predictable pharmacokinetics
Non-scheduled status following scientific review by the U.S. Drug Enforcement Administration
No clinically significant dissociative effects observed in preclinical and Phase 1 assessments to date
Not a P-glycoprotein substrate, supporting good oral bioavailability and central nervous system penetration
An active metabolite (nor-Ketamir-2) with a longer half-life

In validated rodent models of neuropathic pain, including paclitaxel-induced neuropathy and sciatic nerve ligation, Ketamir-2 demonstrated superior efficacy compared with ketamine and established neuropathic pain agents, including pregabalin and gabapentin. The drug did not induce hyperlocomotor or psychotomimetic-like behaviors in animal models.

Phase 2a Development Plan

The planned proof-of-concept study is being designed with rigorous methodological standards intended to generate safety and preliminary efficacy data in patients with moderate to severe CIPN.

The Company expects the trial to incorporate clearly defined endpoints, validated neuropathic pain assessment instruments, appropriate statistical powering, and design elements intended to minimize bias and variability. MIRA's objective is to generate a well-controlled dataset suitable for regulatory advancement and potential peer-reviewed scientific publication.

Management Commentary

Erez Aminov, Chairman and CEO of MIRA, stated:

"Completion dosing of Phase 1 marks an important inflection point for MIRA as we advance Ketamir-2 into patient studies. Our objective has been to create a selective oral NMDA modulator with a differentiated safety profile suitable for chronic use. With favorable Phase 1 findings and a clear regulatory path forward, we are now focused on generating clinical efficacy data in a high-unmet-need indication."

Dr. Itzchak Angel, Chief Scientific Advisor of MIRA, added:

"Ketamir-2 was rationally engineered to achieve selective NMDA modulation with a pharmacokinetic and CNS profile distinct from ketamine. The Phase 1 program provides a translational foundation for patient studies. As we move into Phase 2a, our priority is executing a scientifically rigorous trial capable of producing high-quality data that can withstand regulatory and academic scrutiny."

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
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

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MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2