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 cannabinol formulation to reach clinical trials as a therapeutic product.
InMed’s INM-755 for epidermolysis bullosa (EB) in Phase 1 clinical trials
InMed has conducted two Phase 1 studies of INM-755 cream, including treatment on intact skin and treatment on wounded skin, both in healthy volunteers. The active pharmaceutical ingredient (API) in INM-755 cream is cannabinol (CBN), a rare cannabinoid.
The initial clinical trial, Study 755-101-HV, was a randomized, vehicle-controlled, double-blind, Phase 1 trial that examined the safety and tolerability of two strengths of INM-755 cream on intact skin in 22 healthy adult volunteers over a 14-day treatment period. Results of Study 101 indicated that INM-755 cream was safe and well-tolerated on intact skin, caused no systemic or serious adverse effects, and there were no subject withdrawals due to adverse events. Drug concentrations in the blood were very low, as expected.
Study 755-102-HV was a randomized, double-blind, vehicle-controlled study in 8 healthy adult volunteers to test the tolerability of 14 days of application of the cream on epidermal wounds under treatment procedures designed to simulate wound care for epidermolysis bullosa (“EB”) patients with open wounds. Results of Study 102 indicated that INM-755 cream was safe and well-tolerated on induced open epidermal wounds, caused no systemic or serious adverse effects, and there were no subject withdrawals due to adverse events.
A Phase 2 global, multi-center trial in EB patients is being planned, with anticipated regulatory filings in several countries in the first half of 2021.
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 cannabinol formulation under therapeutic development to advance to 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 cannabinol formulation under therapeutic development to advance to clinical trials.
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.