In a positive step for the treatment of the rare genetic dermatological condition known as epidermolysis bullosa (EB), InMed Pharmaceuticals Inc. INM has published top-line data from its INM-755 Phase II study. The data gleaned from the research strongly supports a pathway for further development of the innovative cannabinol (CBN)-based topical skin cream, INM-755, designed to alleviate EB-associated symptoms.
Following the news, Water Tower Research's Robert Sassoon published an update note looking into the results.
The Analyst Note
The INM-755 study observed 18 out of the 19 enrolled participants, providing key takeaways that lend credibility to the therapy's potential. With chronic non-wound itch relief as the main focus due to challenges in patient recruitment, the study showed that a significant 67% of the trial population experienced a clinically meaningful improvement in itch severity. While not statistically significant—a common occurrence in small-scale clinical trials—these outcomes were evaluated as crucial in addressing chronic non-wound itch.
Following this positive data, InMed looks to the future, exploring options for a commercial partnership to further develop and distribute the INM-755 CBN cream. While InMed is open to potential early monetization opportunities through the sale or out-licensing of the program, the company's intent leans toward fostering a commercial partnership rather than independently proceeding with development. This move promises to ease the financial burden on InMed and allow more resources to be allocated to advancing programs on ocular and neurodegenerative diseases.
Originally developed to address the symptoms associated with EB, a condition characterized by skin fragility that causes extensive blistering and wounding, INM-755 has successfully undergone a series of pre-clinical safety pharmacology, toxicology studies, and three Phase I safety and tolerability studies in healthy volunteers. The progression of this unique topical skin cream to patient treatment in a Phase II clinical trial for EB in December 2021 was an impressive feat.
However, there were a number of obstacles in conducting an international multi-site clinical trial for such a rare disease, the greatest being patient recruitment. Despite these challenges, InMed harnessed a wide-lens approach for the trial, welcoming all four subtypes of inherited EB and incorporating multiple endpoints in the study.
With the positive results of the Phase II data now available, InMed plans to re-engage with potential partners in the second half of the year to evaluate their interest in acquiring or licensing the program or partnering in its continued development as an anti-itch cream. If successful, the INM-755 development program is expected to extend beyond EB into broader indications involving itch, promising larger target populations and greater commercial opportunities.
Photo by Hal Gatewood on Unsplash
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