Achieving a long-awaited milestone, MIRA prepares to become a clinical-stage company in early 2025.

On December 19, 2024, MIRA Pharmaceuticals announced the filing of its first investigational new drug (IND) application with the FDA for Ketamir-2, its oral ketamine analog, for the treatment of neuropathic pain.

The IND application includes data from preclinical pharmacology, pharmacokinetics, and toxicology studies of Ketamir-2 along with results from in vitro and in vivo studies, including neuropathic pain models. In parallel with the submission, MIRA is preparing to conduct a complementary neurotoxicity study, as required by the FDA's written feedback to the company’s pre-IND documentation.

Preclinical studies using Ketamir-2 have shown full pain reversal in animals, including the normalization of pain thresholds invalidated neuropathic pain models, along with an encouraging safety profile. Ketamir-2 was designed to address the limitations of existing neuropathic pain treatments through its selective targeting of the N-methyl-D-aspartate (NMDA) receptor, an ion channel in the central nervous system that plays a key role in synaptic function and is involved in many neurological and psychiatric disorders.

Unlike ketamine, Ketamir-2 does not cause sedation or hyperactivity side effects often associated with psychiatric conditions such as schizophrenia, bipolar disorder, and attention deficit hyperactivity disorder (ADHD).

Ketamir-2 is being developed as a non-addictive, non opioid pain therapy. MIRA now enters a 30-day waiting period, during which the FDA examines the IND filing for safety guidelines to ensure that research subjects are not at an unreasonable risk, before it can initiate its Phase I clinical trial in healthy human volunteers. The IND application will go into effect on January 18, 2025, unless the FDA notifies MIRA otherwise.

We anticipate results from MIRA’s Phase I trial will be available by mid-2025 and will give investors an initial indication whether the safety, tolerability, pharmacokinetics, and pharmacodynamics signals observed in animals may translate to humans.

Beyond neuropathic pain, MIRA is targeting major depressive disorder (MDD), major depressive disorder with suicidal ideation (MDD-SI), treatment resistant depression (TDI), and post-traumatic stress disorder (PTSD) as potential additional indications for Ketamir-2.

We reiterate our BUY rating and 12-month price target of $7.50.