PharmaTher Holdings (CSE: PHRM) has seen the US FDA approve the firms application for an investigational new drug. The approval relates to a phase 2 clinical trial to evaluate the use of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.
With the approval now in hand, the company currently anticipates that it will begin enrolling patients in the phase two trial in the third quarter of 2021. From here, if results prove positive, the company will then request a meeting with the FDA to obtain an agreement to move ahead with phase 3 studies under the 505(b)(2) regulatory pathway next year.
The trial, entitled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” is expected to involve up to eight clinical sites in the US. The company will look to randomize a total of up to 36 patients to either ketamine or midazolam, the active control under the study.
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Patients are to be monitored for a period of eight weeks, and graded on the Unified Dyskinesia Rating Scale, with the ultimate goal of determining the improvement in the patients quality of life.
“The FDA’s acceptance of our IND application for ketamine to treat Parkinson’s disease is a significant milestone for us. The FDA IND is our first of many we will aim to obtain, and we are one of the few psychedelics-focused biotech companies that have an IND approved by the FDA for a recognized psychedelic drug.”
Fabio Chianelli, Chief Executive Officer of PharmaTher
PharmaTher Holdings last traded at $0.19 on the CSE.
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