PharmaTher Files FDA Pre-IND Meeting Request for Ketamine in Parkinson’s Disease
(Press Release) — PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCMKTS: PHRRF) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that it has filed its pre-Investigational New Drug (“pre-IND”) meeting request and complete pre-IND briefing documents with the U.S. Food and Drug Administration (“FDA”) to support the clinical development of ketamine in Parkinson’s disease and to evaluate the proposed Phase 2 clinical study for ketamine in the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (“LID-PD”).
“We are pleased to have taken this important step in advancing our ketamine program for Parkinson’s disease via the FDA regulatory pathway, which is part of our overall strategy of progressing our novel ketamine prescription-based therapies to treat neurological disorders for FDA approval,” said Fabio Chianelli, CEO of PharmaTher. “We look forward to finalizing our Phase 2 clinical study for ketamine in Parkinson’s disease and leveraging the pre-IND meeting to unlock additional value in our exclusive FDA-based ketamine programs in depression and pain.”
PharmaTher is progressing its patent portfolio of novel ketamine therapies for Parkinson’s disease, depression and pain via the FDA regulatory pathway. The pre-IND meeting will provide valuable information to pave the way for the Company to conduct a Phase 2 clinical study in the U.S.
Results from preclinical data and case studies in Parkinson’s disease patients have shown that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety and the potential of long-term therapeutic benefit to reduce levodopa-induced dyskinesia, improve on time, and reduce depression. 1–5
Ketamine is an FDA-approved drug with a known safety profile. PharmaTher entered into an exclusive license agreement with the University of Arizona to develop and commercialize ketamine in the treatment of Parkinson’s disease and has filed with the FDA to receive orphan drug designation for ketamine in the treatment of LID-PD.
The Company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease, including Dr. Scott Sherman and Dr. Torsten Falk from the University of Arizona, Dr. Alberto Espay from the University of Cincinnati and Dr. Robert Hauser from the University of South Florida.
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