The global atopic dermatitis market is poised for exceptional growth at approximately 24.1% CAGR during the projection period (2020-2027). Millions of people continue to be affected by debilitating skin ailments which in turn escalates the development of new pharmaceutical drugs. Fact.MR projects the revenue pool of atopic dermatitis market to exceed US$ 19 Bn by 2027 (GLOBE NEWSWIRE, April 06, 2020).
Atopic dermatitis, is a disease of unknown origin that usually starts in early infancy and is typified by pruritis, eczematous lesions, xerosis (dry skin) and lichenifcation of the skin (thickening of the skin and increase in skin marking. It is also knowsn a eczema and atopic eczema. AD is a serious chronic, relapsing skin disease affecting between 10 and 20% of infants and young children, up to 10% of adults and with a lifetime prevalence of 7%.
Current treatments for atopic dermatitis (AD) include first line emolients, then second line corticosteroids and third line immunosupressants (calcineurin inhibitors). PDE4 inhibitors and biologics drugs account for leading share in more severe atopic dermatitis market. All of these medications carry significant safety liabilities, which limit their use. Antihistamines also appear to be useful agents for AD. The two topical immunosupressants pimecrolimus (Novartis’ Elidel) and tacrolimus (Astellas’ Protopic) are the leading branded products fot AD. Protopic was approved in 2000 and Elidel was approved in 2001. In 2005, a “black box” warning for potential cancer risk was added to the labelling of Novartis’ Elidel and Astellas/Fujisawa’s Protopic , causing a decline in both drugs. Therefore, there is an unmet medical need for a safe efficacious medicine that treats mild to moderate AD, particularly in infants and young children, with the opportunity to expand into severe AD. In addition, new therapies will need to have an improved safety profile compared to current standards of care that allows them to be deployed for long term treatment in mild to moderate disease and be used in the treatments of infants and young children. Carocell Bio aims to take JEL0305 through to phase IIb clinical proof of concept as a treatment for atopic dermatitis. Our aim is to progress our AD program through to human Phase IIb clinical proof of concept within 5 years from funding then outlicense to a pharma partner (AZ has first rights as part of the original licensing deal).
There is much interest in atopic dermatitis in both large and medium sized pharmaceutical companies. There are currently over 40 clinical and preclinical R&D programs aimed at addressing this unmet medical need. However, of all the clinical and preclinical programs we are aware of, only our approach targets more than one aspect of the disease and so has any hope of breaking the progress of inflammation–itch–infection. Carocell Bio ’s chosen compound, JEL0305, in combination with Nanocin, a nanoparticle-based delivery system with inherent bactericidal qualities, will address both the inflammation and bacterial infestation found in atopic dermatitis. With a relevant safety profile and excipient, we may also be able to support skin barrier function with continued dosing until natural barrier function returns.
It is now recognised that inflammation is the cause of senescence. It is hypothesised that chronic therapy with topical JEL0305, permitted because of safety as well as efficacy, could firstly prevent the recurrence of the disease and eventually lead to a delay in aging of the skin to which it is applied. Clinical trials will help prove this exciting prospect.
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