InMed Pharma Advances Clinical Trials with CRO Deal
June 14th, 2017
News, Top News
The widespread potential for cannabinoids is quickly being recognized by the pharmaceutical industry as companies rush to develop therapeutics targeting many medical conditions. While GW Pharmaceuticals plc (NASDAQ: GWPH) is the most well-known company in the space, investors should consider many other companies that are rapidly advancing therapeutics that could become the next blockbuster drugs.
In this article, we will look at InMed Pharmaceuticals Inc. (CSE: IN) (OTCQB: IMLFF) and the progress it is making in advancing its lead clinical trial candidate.
Innovative Clinical Program
InMed Pharma is a pre-clinical stage biopharmaceutical company that specializes in the development of cannabinoid-based prescription drug therapies that leverage its novel drug delivery systems. Using a proprietary bioinformatics database, the company rapidly identifies cannabinoid compounds with the potential to address serious medical conditions. This process enables the company to efficiently develop highly-specialized therapies across many conditions.
The company’s proprietary Bioinformatics platform uses algorithms to assess the different active sites on cannabinoids and screen them against approved drug structures, disease site receptors, genetic profiles of diseases, and the involvement of proteins and chemical metabolites in disease pathways. The goal is to select specific cannabinoids – or combinations of cannabinoids – that may play a role in regulating diseases, with a higher likelihood of success.
InMed’s Biosynthesis process then takes over, differing from many large competitors such as GW Pharmaceuticals, in that the company can access minor cannabinoids that are currently economically unfeasible to develop into drugs. InMed quickly and economically replicates niche cannabinoids by injecting their DNA into an E. coli cell that rapidly divides – a process similar to the way insulin is produced on a massive scale to help millions of diabetics around the world.
Beginning Pre-Clinical Trials
InMed Pharma’s lead clinical program is INM-750 targeting epidermolysis bullosa (EB), which is a condition affecting about 50,000 patients across North America, Europe, and Japan. While the condition has no approved treatments, Scioderm was recently acquired by Amicus in September 2015 for $847 million with its Phase III Zorblisa™ program. JP Morgan and Cowen research reports estimated peak sales of $900 million to $1.2 billion for the drug. Zorblisa™ is being evaluated as a therapy for the treatment of lesions and blistering, two symptoms associated with EB.
The company’s INM-750 has several mechanisms of action in the skin to deliver symptomatic relief, including accelerated wound healing, pain reduction, itch reduction, reduced inflammation, and antimicrobial activity. In addition, the therapeutic may re-establish the epidermal-dermal junction by upregulating specific keratins in the skin, which could essentially reverse the disease.
On June 13th, the company announced an agreement with Pharmaseed Ltd., Israel’s largest GLP-certified pre-clinical contract research organization, to develop a final formulation of INM-750 for continued R&D, including IND-enabling pharmacology and toxicology studies and subsequent clinical studies. The move marks the first step on the pathway to approval status, which management anticipates sometime in the next 4-5 years.
Completing this important phase is a major step forward in InMed’s development program. Not only will it enable the EB study, but completing the toxicology and formulation processes could make those steps much more efficient for future potential trials in other wound healing applications.
InMed Pharmaceuticals Inc. (CSE: IN) (OTCQB: IMLFF) represents a compelling investment opportunity in the cannabinoid therapeutics space. In addition to INM-750, the company has two other R&D programs targeting glaucoma and pain management. The early clinical results from these programs could generate significant catalysts for investors over the coming years and help propel shares significantly higher over the long-term.
With a market capitalization of just about $20 million, the company trades at a fraction of its potential if successful in commercializing its clinical pipeline. Management’s engagement of a reputably CRO represents an important next step in preparing for the clinical trial process that could generate significant catalysts for the company.
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