PharmaTher Provides Research and Development Update and Milestones
Channel: RICH TV LIVE
Date: 2021-06-10

PharmaTher Provides Research and Development Update and Milestones - RICH TV LIVE - June 10, 2021 -  PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to provide an update on the research and development initiatives of its psychedelic product programs and upcoming milestones for 2021.
“We are well-positioned, both financially and operationally, to execute on our remaining milestones for 2021, which includes completing a Phase 2 study with ketamine to treat Parkinson’s disease, a Phase 2 study with KETABET™ for treatment-resistant depression, and the development of our novel microneedle patches for delivering psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD,” said Fabio Chianelli, CEO of PharmaTher.  “The recent FDA acceptance of our IND to proceed to a Phase 2 study in Parkinson’s disease will pave the way for us to confidently submit future IND’s and advance clinical studies evaluating novel uses, formulations and delivery forms of psychedelics to treat various mental health, neurological and pain disorders.”

FDA Phase 2 Clinical Studies

For the rest of 2021, PharmaTher will focus on advancing three promising developments through clinical studies:

Ketamine for Parkinson’s Disease

Following the FDA acceptance of the Company’s investigational new drug application 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, the Company has begun clinical trial start-up activities to begin enrolling patients in Q3-2021 and to announce clinical results in Q4-2021.

KETABET™ for Treatment-Resistant Depression

The Company is preparing a pre-IND meeting request and briefing documents to submit to the FDA to support the clinical development of KETABET™ and the Phase 2 study for treatment-resistant depression.  The Company intends to file the pre-IND meeting request this month, obtain FDA feedback on its clinical study design, and file the IND in Q3-2021.

With the overlap of the clinical operations from the Parkinson’s disease study, the Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 study in Q3/Q4-2021.  The aim is to share clinical results by the end of this year.

Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s Disease”)

Following the Company’s recent submission to receive orphan drug designation for ketamine to treat ALS, the Company is working with its clinical advisors in finalizing a proposed Phase 2 study design. The objective is to request a pre-IND meeting with the FDA in Q3-2021 and submit the IND in Q4-2021.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS, which was discovered by Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O.  Preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

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