INM-755 for the Treatment of Epidermolysis Bullosa
INM-755 is a cannabinol topical cream under development for the treatment of epidermolysis bullosa. INM-755 cream for EB is the first, and currently the only, cannabinol formulation being tested in clinical trials as a therapeutic product.
InMed’s INM-755 for epidermolysis bullosa (EB) has completed two Phase 1 clinical trials
InMed has filed Clinical Trial Applications in several countries as part of a Phase 2 clinical trial of INM-755 (cannabinol) cream in Epidermolysis Bullosa (“EB”). Responses from the National Competent Authorities (“NCAs”) and Ethics Committees (“ECs”) are expected throughout July and August 2021; timing will vary slightly by country due to differences in local procedures and results are expected in the second half of 2022.
The Phase 2 study, 755-201-EB, is designed to enroll up to 20 patients, conservatively within 10-12 months, and will take place at 10 pre-qualified clinical sites in several countries. All four subtypes of inherited EB, being EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome, are eligible for this study in which InMed will evaluate the safety of INM-755 (cannabinol) cream and its preliminary efficacy in treating symptoms and healing wounds over a 28-day period. The study will use a within-patient, double-blind design whereby matched index areas will be randomized to INM-755 (cannabinol) cream or vehicle cream as a control. To learn more about this EB study, view the detailed study description on the National Institutes of Health (NIH) clinicaltrials.gov website.
InMed has completed two Phase 1 studies of INM-755 (cannabinol) cream, including treatment on intact skin and treatment on wounded skin, both in healthy volunteers.
In these Phase 1 clinical trials in healthy volunteers, INM-755 (cannabinol) cream was demonstrated to be well-tolerated on both normal, intact skin as well as on open epidermal wounds and caused no delay in wound healing. The Phase 1 studies provide a strong body of evidence demonstrating the overall safety and tolerability of INM-755 cream. These data support moving forward into Phase 2 studies in patients with EB.
Preclinical studies show CBN potential in managing symptoms of EB as well as improving skin integrity in a subset of EB patients
InMed completed extensive safety pharmacology and toxicology studies of CBN and INM-755 cream that demonstrated promising results and supported advancing the compound into clinical trials.
In preclinical pharmacology studies, CBN demonstrated activity in reducing markers of inflammation and pain. It also upregulated expression of a type of keratin (keratin 15, or K15), which might lead to improved skin integrity and reduced blister formation in EB simplex (EBS) patients with mutations of another keratin (keratin 14, or K14). Its anti-inflammatory activity may be beneficial in healing chronic wounds where healing has been prevented by prolonged inflammation.
Source: Marinkovich Medicine EB Subtypes
CBN demonstrates an excellent safety profile
InMed conducted several preclinical safety pharmacology and toxicology studies using CBN at very high doses that achieved systemic exposure (blood levels) hundreds of times higher than what is expected to occur with topical dosing in humans. No adverse events were seen on central nervous system (CNS) function in a rigorous and extensive evaluation of CNS effects; 108 aspects of behavior posture, gait, and movement were assessed. In that study, the blood levels were more than 10,000 times what is expected to occur with topical dosing in humans. No adverse effects were observed in preclinical studies where the drug was applied either as a cream (for local effects) or injected under the skin (for systemic effects) daily for 28 days, even at the highest doses.
Results from two Phase 1 clinical studies of INM-755 cream in healthy volunteers treated for 14 days indicated that INM-755 cream was safe and well-tolerated on intact skin as well as open epidermal wounds, caused no systemic or serious adverse effects, and there were no subject withdrawals due to adverse events.
INM-755 cream is the first, and currently the only, cannabinol formulation under therapeutic development in clinical trials
There are more than 100 rare cannabinoids present in the Cannabis plant, albeit at very low levels. The active pharmaceutical ingredient (API) in INM-755 cream is cannabinol (CBN), a rare cannabinoid. INM-755 cream is the first, and currently the only, CBN formulation being studied in clinical trials as a potential therapeutic to treat disease.
There are slight differences in cannabinoid structures that can result in profound differences in activity, safety and potential therapeutic effect in the human body.
In preclinical studies, InMed investigated the safety and therapeutic potential of a number of different cannabinoids. Of the cannabinoids tested, which included widely known cannabidiol (CBD), only cannabinol (CBN) up-regulated keratin 15, which might lead to reduced blister formation in EB simplex (EBS) patients with mutations in another keratin (keratin 14, or K14). Additionally, CBN was a strong candidate to regulate a number of symptoms that EB patients face on a daily basis, such as reducing inflammation and pain.
InMed Attends 2020 EB World Congress
View our EB World Congress scientific posters
What is epidermolysis bullosa?
Epidermolysis bullosa, or EB, is a rare genetic skin disease characterized by fragile skin that can lead to extensive blistering and wounding. It is a painful and often debilitating disease that affects skin and mucous membranes, particularly of the gastrointestinal tract, genitourinary and respiratory systems. According to debra of America, a non-profit organization supporting the EB community, EB affects 1 out of 20,000 births in the United States – approximately 200 children a year are born with EB. The disease has no cure and all current treatments are directed towards symptom relief.