Business
MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site
Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment MIAMI, FL / ACCESSWIRE / November 20, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025. The Phase IIa study, planned to start in Q4 2025, will focus on diabetic neuropathy patients, with initial human efficacy results anticipated in the first half of 2026.The trial leverages CHDR's proprietary PainCart® technology, a validated tool for measuring pain response. This advanced technology allows MIRA to assess early signs of efficacy in healthy subjects during Phase I, a capability that is typically unavailable at this stage of development. Psychoactivity assessments will also be conducted separately as part of an independent evaluation. The unique capabilities of PainCart® was a key reason for selecting CHDR as the trial site, allowing MIRA to gain valuable insights into Ketamir-2's potential for pain management earlier in the clinical process together with information about safety and pharmacokinetics.Innovative Study Design Focused on Early Proof-of-Concept DataThe Phase I/IIa trial is structured as a randomized, double-blind, placebo-controlled study conducted in two parts:Phase I: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts in healthy subjects will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. PainCart will be used to measure pain response, providing robust early efficacy data, while psychoactivity will be assessed separately through dedicated testing.Phase IIa: The Proof of Concept (POC) study, planned to begin in the last quarter of 2025, will focus on diabetic neuropathy patients, generating efficacy data in a patient population to validate the Phase I findings.\"This innovative protocol is designed to deliver early, robust proof-of-concept data, advancing Ketamir-2's clinical development and positioning us for st...