Biotech pharmaceutical Company
PharmaTher Inc. (CSE: PHRM, OTCQB: PHRRF, Forum) announced on Tuesday that it had filed an application with the US Food and Drug Administration to receive Orphan Drug Designation for ketamine to treat amyotrophic lateral sclerosis, also known as Lou Gehrig's disease.
Ketamine is crucial to advancing the clinical development of the Company’s product pipeline and PharmaTher Inc.’s Chief Executive Officer, Fabio Chianelli stated in a news release that it has tremendous potential for not only mental illness and pain disorders but also for neurodegenerative diseases such as ALS.
“Our FDA orphan drug application for ketamine to treat this life-threatening disease complements our patent portfolio that aims to protect the proposed method of use and dosage claims of ketamine for ALS. Although patent protection or market exclusivity could last beyond 2040, our intention to seek orphan drug designation is to leverage the expedited regulatory and clinical development incentives offered by the FDA for repurposed drugs in treating rare diseases. We are working with our clinical and regulatory advisors in preparing our clinical development plan and study protocol while leveraging our recent investigational new drug application approved by the FDA for Parkinson’s disease to proceed with a potential phase 2 clinical study in ALS patients this year.”
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Earlier this month, the FDA had approved PharmaTher’s
Investigational New Drug application to proceed with the Phase 2 clinical trial of ketamine. This approval allowed PharmaTher to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of Ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.
PharmaTher expects to begin enrolling patients for the Phase 2 clinical trial in Q3 2021. Assuming the Phase 2 clinical trial is positive, the company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study next year.
FULL DISCLOSURE: PharmaTher Inc. is a client of Stockhouse Publishing.