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Item 8.01 Other Events
MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog
Study demonstrated that Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption and a favorable duration of action supporting once-daily dosing.
On September 22, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy volunteers.
The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and pharmacokinetic (PK) characterization.
Pharmacokinetic Results
| ● | Dose-proportional increases in exposure (Cmax and AUC) were observed across all dose levels tested. | |
| ● | Median time to maximum plasma concentration (Tmax) was reached within 1–2 hours, consistent across cohorts. | |
| ● | Terminal half-life (t½) of Ketamir-2 ranged from 2 to 5 hours. | |
| ● | The primary active metabolite, nor-Ketamir, demonstrated a half-life of 6.5 to 8.5 hours. |
Safety and Tolerability Results
| ● | Ketamir-2 was generally safe and well tolerated across all four cohorts. | |
| ● | No dose-limiting toxicities or serious adverse events were observed. | |
| ● | Reported treatment-emergent adverse events were transient and resolved without intervention. | |
| ● | Central nervous system (CNS) safety was monitored using validated tools (C-SSRS, Bowdle VAS, KSET). Across all SAD cohorts, no clinically significant adverse effects of Ketamir-2 observed. |
Next Steps
Based on the data, the Company is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed by a Phase 2a trial in patients with neuropathic pain.
Additional Information
The U.S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Dated: September 22, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |