Policy & Regulation
InMed Pharmaceuticals granted Clinical Trial Application approval for INM-755 phase one trial
10 December 2019 -

InMed Pharmaceuticals Inc (TSX: IN)(OTCQX: IMLFF), a clinical stage biopharmaceutical company developing cannabinoid-based medications targeting diseases with high unmet medical needs, has received regulatory and ethics board approval for its Clinical Trial Application to conduct a phase one trial of INM-755, a cannabinoid-based topical cream, in the Netherlands.

It was reported yesterday that the company aims to start patient recruitment immediately.

The initial clinical trial study 755-101-HV is a randomised, double-blind, vehicle-controlled, Phase 1 study that is intended to assess the local and systemic safety, tolerability, and pharmacokinetics of INM-755 applied daily on intact skin in healthy volunteers. Two strengths of INM-755 cream, plus vehicle-only, will be evaluated in 22 adult patients over a 14-day treatment period. The product is a single-cannabinoid topical cream under development for the treatment of symptoms associated with epidermolysis bullosa. It is also likely to address the underlying disease by improving skin integrity in a subset of epidermolysis bullosa patients.

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