MIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling Studies
Rhea-AI Summary
MIRA Pharmaceuticals (NASDAQ: MIRA) reported advancement of its two lead preclinical programs, MIRA-55 for chronic inflammatory pain and SKNY-1 for obesity and addiction-related disorders, toward the next phase of IND-enabling development. Recent work includes formulation optimization, chemistry, manufacturing and controls (CMC), manufacturing development, and exploratory non-GLP 7‑day repeated-dose toxicology and toxicokinetic studies in Sprague Dawley rats and Beagle dogs, with sample analysis and histopathology ongoing.
According to MIRA, these coordinated activities are intended to inform design of future GLP-compliant toxicology studies and support clinical development. The company highlights prior preclinical data showing MIRA-55 normalized pain and reduced inflammation in a validated model, and SKNY-1 produced dose-dependent weight loss, lipid normalization, and reduced compulsive feeding and nicotine-seeking behaviors. MIRA also notes that MIRA-55, SKNY-1 and Ketamir-2 are not classified as controlled substances by the U.S. DEA.
Positive
- Completion of 7-day tox/PK dosing in rats and dogs for MIRA-55 and SKNY-1
- Parallel CMC, formulation and manufacturing work to support future GLP toxicology and clinical studies
- MIRA-55 preclinical data normalized pain and reduced inflammation, outperforming injected morphine in a validated model
- SKNY-1 preclinical data showed dose-dependent weight loss, lipid normalization and reduced compulsive feeding and nicotine-seeking
- DEA determined MIRA-55, SKNY-1, and Ketamir-2 are not classified as controlled substances
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 10 | Formulation results | Positive | +0.5% | Lead MIRA-55 oral formulation showed favorable bioavailability and tissue distribution. |
| Jul 06 | Formulation results | Positive | +1.1% | Optimized SKNY-1 formulation supported brain penetration and potential once-daily dosing. |
| Jun 25 | Preclinical mechanism data | Positive | -0.3% | MIRA-55 showed a mechanism distinct from THC and anxiolytic activity. |
| Jun 17 | Phase 2a protocol | Positive | +3.0% | MIRA submitted a Phase 2a Ketamir-2 protocol to the FDA. |
| Jun 04 | Exclusive license agreement | Positive | +5.0% | MIRA secured worldwide exclusive rights to MIRA-55 and SKNY-1. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
MIRA's recent news reactions were mostly positive, although one positive preclinical update produced a negative reaction.
Key Terms
pharmacokinetic medical
toxicokinetic medical
chemistry, manufacturing and controls technical
ind-enabling regulatory
glp-compliant regulatory
histopathology medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Completion of 7-Day Toxicology and Pharmacokinetic Studies Advances Non-Opioid Pain Therapy and Obesity Candidate Development
MIAMI, July 30, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced continued advancement of its two lead preclinical programs, MIRA-55, an investigational oral non-opioid drug candidate for chronic inflammatory pain, and SKNY-1, an investigational oral drug candidate for obesity and addiction-related disorders.
Over the past several weeks, the Company has advanced both programs through multiple coordinated development activities, including formulation optimization, chemistry, manufacturing and controls (CMC) activities, manufacturing development, and exploratory non-GLP toxicology and toxicokinetic studies. Collectively, these milestones support the continued progression of both programs toward the next phase of IND-enabling development.
Following previously announced formulation optimization for both candidates, MIRA has continued advancing pharmaceutical development activities designed to support future nonclinical and regulatory development. Current CMC efforts include analytical, formulation, and manufacturing development activities intended to support future GLP-compliant toxicology studies and subsequent clinical development.
In parallel, the Company has completed the in-life dosing and scheduled necropsy phases of exploratory, non-GLP, 7-day repeated-dose toxicology and toxicokinetic studies evaluating MIRA-55 and SKNY-1 in both Sprague Dawley rats and Beagle dogs.
These exploratory studies are designed to provide information regarding tolerability, systemic exposure and dose selection to help inform the design of future GLP-compliant IND-enabling toxicology studies. Sample analysis, toxicokinetic evaluation and histopathology remain ongoing.
"Our objective is to systematically advance differentiated oral therapeutics that address significant unmet medical needs," said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals. "MIRA-55 and SKNY-1 continue to make meaningful progress across the key development activities required before entering IND-enabling studies. Advancing formulation, CMC, manufacturing and exploratory toxicology in parallel reflects the disciplined execution of our development strategy and our commitment to efficiently moving both programs toward clinical development."
Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA Pharmaceuticals, added, "Successful drug development requires the integration of pharmaceutical development, manufacturing, pharmacology and nonclinical safety into a comprehensive development program. The exploratory studies currently undergoing analysis are intended to provide important information that will support the design of appropriately structured GLP toxicology studies, while our continued CMC and manufacturing activities strengthen the overall development foundation for both MIRA-55 and SKNY-1."
The Company believes these milestones further strengthen the development packages for both programs and reflect continued execution across its pipeline as it advances differentiated oral therapeutics toward future clinical development.
About MIRA-55
MIRA-55 is an investigational oral small-molecule drug candidate being developed as a potential non-opioid therapy for chronic inflammatory pain.
In previously reported preclinical studies, oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model, outperforming injected morphine. The compound demonstrated direct CB2 receptor-mediated anti-inflammatory activity. Additional mechanistic studies showed that MIRA-55 acts through a pharmacological mechanism distinct from THC, produces anxiolytic effects, and does not produce the central nervous system effects associated with THC. A lead oral formulation demonstrated favorable bioavailability with reproducible distribution to brain and liver tissue.
MIRA-55 was designed to selectively modulate cannabinoid receptor pathways associated with inflammation and pain.
About SKNY-1
SKNY-1 is an investigational oral small-molecule drug candidate being developed for obesity and addiction-related disorders.
In peer-reviewed preclinical studies published in the International Journal of Molecular Sciences, oral SKNY-1 demonstrated dose-dependent reductions in body weight, lipid normalization, and reduced hepatic triglyceride accumulation. The compound attenuated compulsive feeding and nicotine-seeking behaviors in validated experimental models. In separate behavioral studies, SKNY-1 was devoid of anxiety-related effects despite engaging central cannabinoid pathways, distinguishing it from earlier CB1-targeting therapies. A lead oral formulation demonstrated favorable bioavailability with robust brain penetration and substantial liver exposure, supporting once-daily oral dosing potential.
About MIRA Pharmaceuticals, Inc.
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics for neurologic, inflammatory, metabolic and neuropsychiatric disorders. The Company's pipeline includes Ketamir-2, an investigational oral therapy that has completed a Phase 1 clinical trial and is advancing toward a Phase 2a clinical study under its active U.S. Investigational New Drug (IND) application for chemotherapy-induced peripheral neuropathy; MIRA-55, an investigational oral drug candidate for chronic inflammatory pain; and SKNY-1, an investigational oral drug candidate for obesity and addiction-related disorders. Following scientific review, the U.S. Drug Enforcement Administration (DEA) has determined that MIRA-55, SKNY-1, and Ketamir-2 are not classified as controlled substances.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally may be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans, regulatory pathway, safety profile, efficacy, anticipated clinical development, commercialization prospects, market opportunity, and future development of MIRA-55, SKNY-1, Ketamir-2, and the Company's other product candidates.
These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's current beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's subsequent filings with the U.S. Securities and Exchange Commission (“SEC”).
Forward-looking statements contained in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.
Investors are cautioned not to place undue reliance on these forward-looking statements. Additional information regarding these and other risks and uncertainties is contained in the Company's filings with the SEC, including its Annual Report on Form 10-K and subsequent filings, available at www.sec.gov and in the Investors section of the Company's website at www.mirapharmaceuticals.com. Forward-looking statements should be considered in light of these risks and uncertainties.
Contact:
Krystina Quintana
MIRA Pharmaceuticals, Inc.
info@mirapharma.com
(786) 432-9792
