Pharmather Inc (CSE: PHRM) is successfully progressing on the development of its proposed phase 2 clinical study on ketamine in the use of levodopa-induced dyskinesia in patients with Parkinson’s disease. The company this morning announced that it has successfully completed a Type B pre-investigational new drug meeting with US FDA.
The agreement was marked successful as a result of the feedback received by the US Food and Drug Administration. Effectively, the written response from the agency confirmed that the investigational new drug regulatory pathway was acceptable for use, enabling the potential for accelerated clinical development for drug approval.
The FDA as such is regarded as having been supportive of the proposed phase 2 clinical study on ketamine, and the measures by which the company intends to determine the success of the study. The agency also recommended the use of certain efficacy and safety parameters and endpoints, which would support future pivotal clinical trials of the drug.
“We were very pleased with the outcome of our pre-IND meeting with the FDA as it provided positive guidance to support our clinical development program for ketamine to treat Parkinson’s disease patients while also outlining the various safety and efficacy endpoints to be used in the Phase 2 study to support a potential Phase 3 clinical study in the future.”
Fabio Chianelli, CEO of PharmaTher
The company will now focus on completing the IND application, with the firm currently targeting the second quarter of 2021 to initiate the phase 2 clinical study.
PharmaTher last traded at $0.495 on the CSE.
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