MIRA Pharmaceuticals Completes Phase 1 SAD for Ketamir-2, No Safety Concerns

MIRA Pharmaceuticals has completed the Single Ascending Dose (SAD) phase of its Phase 1 clinical trial for Ketamir-2, encountering no severe adverse effects. Conducted at the Hadassah Clinical Research Center in Israel, the study showed a favorable safety profile, paving the way for the Multiple Ascending Dose (MAD) stage. This trial aims to determine the safety and pharmacokinetics of Ketamir-2, designed for neurologic and neuropsychiatric conditions.

The SAD phase included 32 participants and assessed doses ranging from 50 mg to 600 mg, accompanied by comprehensive CNS safety evaluations. The MAD phase will examine daily doses over five days in 24 participants.

MIRA is also advancing towards a Phase 2a trial scheduled for late 2025, focusing on Ketamir-2 as a potential treatment for neuropathic pain, a significant market driven by rising cases of diabetes and aging populations.