PharmaTher Submits For Phase 2 Clinical Trial With FDA
PharmaTher Holdings (CSE: PHRM) is looked to complete a phase two clinical trial. The company this morning announced the submittal of an investigational new drug application with the US FDA for its drug focused on levodopa-induced dyskinesia in patients with Parkinson’s disease.
The phase two clinical trial will look to evaluate the safety, efficacy, and pharmacokinetics in the use of what is referred to as low-dose ketamine for the stated indication. More specifically, the trial is titled as, “A Multi-Center, Phase IIA, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.”
The company will look to conduct the clinical trials across up to eight sites across the US, with an initial 36 test subjects. The main item focused on by the company is what is known as the “Unified Dyskinesia Rating Scale,” which the company will look to raise to a score of “Week 8” from “Baseline”. Ketamine is currently an FDA-approved drug that is used most commonly as an anesthetic agent.
“The submission of our IND application with the FDA is an important milestone as it provides us with a solid foundation to advance our ambition in commercializing ketamine and unlocking its therapeutic potential through novel uses, formulations and delivery methods in the treatment of neurodegenerative diseases (ie. Parkinson’s disease and Lou Gehrig’s disease), mental illness (ie. Depression and PTSD) and chronic pain.”
Fabio Chianelli, CEO of PharmaTher
Assuming positive results are received from the clinical trial, the company has indicated that it will request a meeting with the FDA. That meeting is set to discuss a plan and reach an agreement to move to a phae 3 clinical trial.
PharmaTher last traded at $0.245 on the CSE.
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