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 for EB is the first cannabinol formulation to reach clinical trials as a therapeutic product.
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InMed’s INM-755 for Epidermolysis Bullosa (EB) in Phase 1 clinical trials
InMed is conducting two Phase 1 studies of INM-755 cream, including treatment on intact skin and treatment on wounded skin, both in healthy volunteers. The first Phase 1 trial has completed and a Clinical Trial Application (CTA) has been filed to begin its second Phase 1 clinical trial in healthy volunteers. The active pharmaceutical ingredient (API) in INM-755 is cannabinol (CBN), a rare cannabinoid.
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, was being evaluated in 22 adult subjects over a 14-day treatment period.
The second Phase 1 clinical trial, Study 755-102-HV, will involve 8 healthy volunteers. The study involves testing INM-755 cream on open wounds of the 8 subjects.
A Phase 1-2 global, multi-center trial in EB patients is planned after Phase 1 safety studies, with anticipated regulatory filings seeking permission to conduct this trial at the end of 2020.
INM-755 preclinical studies show 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 INM-755 that demonstrated promising results and supported advancing the compound into clinical trials.
In preclinical pharmacology studies, INM-755 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
INM-755 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.
In summary, the toxicology studies conducted to date support the initial clinical investigations in healthy volunteers with up to 14 days of topical application on the skin and will support a subsequent study in patients with EB in which creams will be applied for up to 28 days.
INM-755 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 is cannabinol (CBN), a rare cannabinoid. INM-755 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, INM-755 was a strong candidate to regulate a number of symptoms that EB patients face on a daily basis, such as reducing inflammation and pain.
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.