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

MIRA (NASDAQ:MIRA) initiated dosing in the final cohort of its Phase 1 multiple ascending dose study of Ketamir-2, an oral NMDA receptor antagonist.

Rhea-AI Summary

MIRA (NASDAQ:MIRA) initiated dosing in the final cohort of its Phase 1 multiple ascending dose study of Ketamir-2, an oral NMDA receptor antagonist. To date, 50 healthy volunteers have been dosed and 6 subjects remain.

The company expects to complete Phase 1 by end of Q1 2026, plans to submit a Phase 2a protocol for chemotherapy-induced peripheral neuropathy (CIPN) to the FDA, and anticipates initiating Phase 2a in Q2 2026, subject to regulatory feedback. MIRA will seek Fast Track designation and present Phase 1 data at AACR April 17-22, 2026.

Positive

• 50 healthy volunteers dosed in Phase 1 to date
• No serious adverse events reported to date
• Company plans Phase 2a initiation in Q2 2026 (subject to FDA)

Negative

• Phase 1 completion and Phase 2a timing remain contingent on FDA feedback
• Final cohort still has 6 subjects remaining before Phase 1 completion
• No patient efficacy data yet—Phase 1 conducted in healthy volunteers

Argus Feb 3 session

-1.65% close to close Open Argus

Details

News Market Reaction – MIRA

On Feb 3, the day this news came out, MIRA closed 1.65% below the previous close.

Data tracked by StockTitan Argus for the Feb 3 session.

Key Figures

Phase 1 volunteers: 50 healthy volunteers Final cohort subjects: 6 subjects Phase 1 completion target: End of Q1 2026 +4 more

Phase 1 volunteers

50 healthy volunteers

Dosed to date in Ketamir-2 Phase 1 MAD trial

Final cohort subjects

6 subjects

Remaining in final Phase 1 Ketamir-2 MAD cohort

Phase 1 completion target

End of Q1 2026

Expected completion of Ketamir-2 Phase 1 program

Phase 2a start target

Q2 2026

Anticipated initiation of Phase 2a CIPN study, subject to FDA feedback

AACR presentation dates

April 17-22, 2026

Planned presentation of Ketamir-2 Phase 1 data at AACR

BIO Summit dates

March 2-3, 2026

BIO Partnering Investment & Growth Summit attendance for partnering

IND-enabling goal

Year-end 2026

Target for SKNY-1 and MIRA-55 to reach IND-enabling status

Previous Clinical trial Reports

5 past events · Latest: Oct 24

Same Type 5 events

1. Oct 24

   Phase 1 MAD start

   24h Move

   -3.2%

   Initiated MAD Phase 1 Ketamir-2 and chose CIPN as lead Phase 2a indication.

2. Sep 22

   Phase 1 SAD results

   24h Move

   +6.4%

   Reported favorable Phase 1 SAD topline data with no serious adverse events.

3. Aug 19

   SAD completion

   24h Move

   -4.0%

   Completed SAD stage for Ketamir-2 and advanced to MAD dosing cohorts.

4. Apr 16

   Animal model data

   24h Move

   +19.3%

   Positive Ketamir-2 data in diabetic neuropathy animal model with strong efficacy.

5. Apr 01

   Phase 1 enrollment

   24h Move

   -2.5%

   Enrolled first subjects into Phase 1 clinical trial of Ketamir-2 for neuropathic pain.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

multiple ascending dose (mad), pharmacokinetics, nmda receptor antagonist, chemotherapy-induced peripheral neuropathy (cipn), +4 more

8 terms

multiple ascending dose (mad) clinical

"final cohort of its Phase 1 multiple ascending dose (MAD) clinical trial evaluating"

Multiple ascending dose (MAD) is a research process used to test how a new medicine affects the body when given in increasing amounts over several doses. It helps researchers find the safest and most effective dose before the drug is widely used. For investors, understanding MAD studies is important because successful results can signal progress toward new treatments and potential future profits.

pharmacokinetics clinical

"designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

nmda receptor antagonist medical

"Ketamir-2, its lead oral NMDA receptor antagonist."

A NMDA receptor antagonist is a type of drug that blocks a specific receptor in the brain involved in passing electrical signals between nerve cells; think of it as dimming an over-bright lamp to calm an overstimulated room. It matters to investors because these drugs can treat conditions from pain and anesthesia to certain psychiatric and neurological disorders, so clinical results, safety profiles, and regulatory decisions strongly affect a company’s market value and future sales potential.

chemotherapy-induced peripheral neuropathy (cipn) medical

"Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy (CIPN),"

Chemotherapy-induced peripheral neuropathy (CIPN) is nerve damage caused by certain cancer drugs that can produce numbness, tingling, burning pain or weakness in the hands and feet; think of nerves like electrical wiring that becomes frayed by treatment. It matters to investors because CIPN can limit a drug’s dose or use, reduce patient quality of life, drive demand for supportive therapies, affect clinical trial outcomes and regulatory approval, and create ongoing treatment costs and market opportunities.

fda fast track designation regulatory

"The Company intends to pursue FDA Fast Track designation for Ketamir-2 as the"

FDA Fast Track designation is a U.S. regulatory status that gives a drug or treatment a faster, more interactive path through development and review because it targets a serious condition with unmet medical need. Think of it as a “fast lane” at the agency that can speed up testing and paperwork, potentially shortening the time to market; for investors, that can lower development risk and accelerate potential revenue, though it does not guarantee approval.

cmc optimization technical

"SKNY-1 and MIRA-55, both of which are currently undergoing CMC optimization,"

CMC optimization is the process of improving a drug’s chemistry, manufacturing and controls so the product can be made consistently, safely and at scale—like refining a kitchen recipe so it yields the same result every time. For investors, it matters because better CMC work cuts production costs, lowers the chance of regulatory delays, supply problems or recalls, and increases the odds a medicine can reach patients and generate revenue.

ind-enabling regulatory

"with the objective of advancing each program into IND-enabling status by year-end 2026."

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.

american association for cancer research (aacr) medical

"data on Ketamir-2 at the American Association for Cancer Research (AACR) Annual Meeting 2026,"

AACR is a professional organization that supports and shares scientific work on cancer biology, treatments and prevention through conferences, publications and research funding. For investors, AACR gatherings and papers act like a clearinghouse where new drug ideas, early clinical results and research partnerships are revealed; those signals can affect biotech valuations because they help show which approaches are gaining scientific traction or may reach patients first.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research (AACR)Annual Meeting

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
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How many participants has MIRA (MIRA) dosed in the Ketamir-2 Phase 1 trial as of February 3, 2026?

MIRA has dosed 50 healthy volunteers so far, with dosing in the final cohort underway. According to the company, 6 subjects remain before Phase 1 completion expected by end of Q1 2026.

When does MIRA expect to complete the Ketamir-2 Phase 1 program and start Phase 2a for CIPN?

The company expects Phase 1 completion by end of Q1 2026 and anticipates starting Phase 2a in Q2 2026, subject to regulatory feedback. According to the company, submission of the Phase 2a protocol to FDA follows Phase 1 completion.

Will MIRA seek any regulatory designation for Ketamir-2 for chemotherapy-induced peripheral neuropathy (CIPN)?

Yes. MIRA intends to pursue FDA Fast Track designation for Ketamir-2 as the program advances into later-stage development. According to the company, this reflects CIPN's unmet medical need and oncology-related nature.

What safety information has MIRA reported from the Ketamir-2 Phase 1 trial?

To date, MIRA reports no serious adverse events in the Phase 1 trial and ongoing review supports program advancement. According to the company, the study is evaluating safety, tolerability, and pharmacokinetics in healthy volunteers.

When and where will MIRA present Ketamir-2 Phase 1 data and pursue partnering opportunities?

MIRA will present Phase 1 data at AACR Annual Meeting, April 17-22, 2026, and will attend the BIO Partnering Summit, March 2-3, 2026 in Miami. According to the company, these events support partnering and strategic discussions.