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Inmed Pharmaceuticals Inc
Symbol IN
Shares Issued 172,283,633
Close 2019-12-09 C$ 0.275
Market Cap C$ 47,377,999
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Inmed receives regulatory nod for INM-755 trial

2019-12-09 08:22 ET - News Release

Mr. Eric Adams reports

INMED RECEIVES CLINICAL TRIAL APPLICATION APPROVAL FOR INM-755, A RARE CANNABINOID FORMULATION UNDER DEVELOPMENT FOR THE TREATMENT OF EPIDERMOLYSIS BULLOSA

Inmed Pharmaceuticals Inc. has received regulatory and ethics board approval of its clinical trial application (CTA) to conduct a phase 1 trial in the Netherlands for INM-755, a cannabinoid-based topical cream. The company intends to initiate subject recruitment immediately.

The initial clinical trial, study 755-101-HV, is a randomized, double-blind, vehicle-controlled, phase 1 study designed to evaluate 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 subjects over a 14-day treatment period.

INM-755, the company's lead product candidate, is a single-cannabinoid topical cream under development for the treatment of symptoms associated with epidermolysis bullosa (EB), a rare genetic skin disease characterized by fragile skin that can lead to extensive blistering and wounding. It may also address the underlying disease by enhancing skin integrity in a subset of EB patients.

"INM-755 is the first rare cannabinoid formulation for the treatment and symptomatic relief of EB to advance to clinical trials," commented Eric A. Adams, president and chief executive officer of Inmed Pharmaceuticals. "Initiating this phase 1 trial of INM-755 was one of our key corporate objectives for 2019. It represents a significant step in bringing forward a potential new treatment option for EB patients who are in significant need of new and more effective treatment options. The extensive preclinical safety, toxicology and chemistry, manufacturing and controls (CMC) data included in the CTA is reflective of the strength of our development program and the company's team."

About Inmed Pharmaceuticals Inc.

Inmed Pharmaceuticals is a clinical-stage biopharmaceutical company developing a proprietary biosynthesis system for the manufacturing of pharmaceutical-grade cannabinoids, as well as a pipeline of cannabinoid-based medications that target diseases with high unmet medical needs. The company is dedicated to delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines.

About epidermolysis bullosa (EB)

EB is the collective name of a group of genetic disorders of connective tissues affecting individuals from birth and is characterized by fragile skin that is easily damaged, leading to extensive blistering and wounding. The blisters may appear in response to minor injury, even from heat, rubbing, scratching or adhesive tape. The disease has no definitive cure and all current treatments are directed toward symptom relief.

About INM-755

INM-755 is a proprietary, topical, single-cannabinoid cream product candidate intended as a therapy in epidermolysis bullosa (EB) and potentially other dermatological indications. It has been specifically designed with the intent of increasing skin integrity in certain EB Simplex patients (the most common form of EB) while treating the major symptoms of the disease in all patients with EB. Preclinical data demonstrate that INM-755 may have a significant impact on certain symptoms of EB (which may include reduction in pain, itch and inflammation). These disease hallmarks are key therapeutic targets for the effective treatment of EB as well as several other dermatological conditions. Additionally, the company's data indicate that INM-755 may have an impact on skin integrity by increasing the production of certain proteins, called keratins, in the skin.

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