January 14, 2022
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FDA accepts IND for phase 2 study of ketamine to treat ALS

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PharmaTher Holdings Ltd., a specialty ketamine prescription-based product development company, announced the FDA has accepted an investigational new drug application for proceeding with a phase 2 clinical trial to examine ketamine for ALS.

The study will take place at the University of Missouri. The FDA first granted orphan drug designation for ketamine as an ALS treatment to PharmaTher prior to it accepting the IND.

If the study produces positive results, PharmaTher will request to meet with the FDA to discuss its plan and reach agreement on a phase 3 clinical study and accelerated marketing approval, the company said in a press release.

In the phase 2 clinical trial, researchers will use a prospective, double-blind, randomized controlled design to examine multiple ascending doses of ketamine among 36 participants with ALS in three sequential cohorts, with 12 participants in each. The proportion of participants at each ketamine dose with dose-limiting toxicities at 12 weeks and 24 weeks represents the primary endpoint.

As secondary endpoints, researchers will use changes from baseline in participant plasma neurofilament light change; change in slope of the ALS Functional Rating Scale-Revised; changes from baseline in percentage of participants with depression measured via the Patient Health Questionnaire-9; change in slope of manual muscle strength testing; and change in slope of forced vital capacity.

“ALS is a devastating neurodegenerative disease with limited treatment options, and ketamine, based on preclinical research, has the potential to have a positive impact on ALS patients,” Fabio Chianelli, CEO of PharmaTher, said in the release.