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atopic dermatitis - eczema

Atopic dermatitis (eczema) – JEL0305

Carocell Bio is more than just a name - it’s an evolution in skin care

Spearheading a movement, we are harnessing peptide-based anti-inflammatory technology to more safely treat skin-related conditions. Our peptides are a potent weapon against skin-related inflammation.

Our lead peptide, JEL0305, has been formulated for topical application, making it a powerful ally against the skin diseases such as atopic dermatitis, AD (eczema).

As a bridge between innovating science and unmet patient needs, we are set to alter the course of treatments available, delivering tangible benefits demonstrated in both cellular and human biopsy studies.

Introduction

Eczema (atopic dermatitis) is a disease of unknown origin that usually starts in early infancy and is typified by pruritis (itch), eczematous lesions, xerosis (dry skin) and lichenification of the skin (thickening of the skin and increase in skin marking).

It is the most common skin disease in children, affecting approximately 15% to 20% of children and 1% to 3% of adults(2,3). Population-based studies in the United States suggest that prevalence is about 10.7% for children and 7.2% for adults (4,5).

Onset of disease commonly presents by 5 years of age, with the highest incidence occurring between the ages of 3 and 6 months, but it can occur at any age (3,6).

Early diagnosis and treatment are essential to avoid complications of eczema and improve quality of life (3). Approximately 60% of patients develop disease in the first year of life and 90% within the first 5 years of life (3).

Twenty percent of children who develop eczema before 2 years of age will have persisting symptoms of disease and 17% will have intermittent symptoms by 7 years of age. Only 16.8% of adults with eczema experience onset after adolescence (7,8,9).

Eczema commonly resolves by the time a child reaches adulthood; however, approximately 10% to 30% of patients will unfortunately continue to suffer symptoms of disease throughout the rest of their lives (10).

Common presentations of Atopic Dermatitis. Left: atopic dermatitis affecting face of an infant; Right: affecting popliteal fossa (back of knee).

Current Treatment Options

Current treatments for eczema include first line topical emollients, then second line topical or oral corticosteroids and third line topical immunosuppressants (calcineurin inhibitors). Antihistamines also appear to be useful agents for eczema as they help with the itch.

Phosphodiesterase (PDE)-4 inhibitors, Janus kinase (JAK) inhibitors and biologics drugs account for a leading share in more severe atopic dermatitis market. All of these medications carry significant safety liabilities, which limit their use to a smaller moderate-severe eczema group.

The two topical immunosuppressants pimecrolimus (Novartis’ Elidel) and tacrolimus (Astellas’ Protopic) are the leading branded products for eczema. 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 sales of both drugs.

Topical PDE-4 inhibitors have now entered the mild-moderate arena in an effort to fill the gap. Unfortunately, the PDE-inhibitors, such as crisborole (Eucrisa), roflumilast (Zoryve) and difamilast (Adquey) can only be prescribed for short-term use and have intolerable side effects such as headache, nausea, application site pain, diarrhea, vomiting, and upper respiratory tract infections. They are the least effective with only 17% efficacy after 4 weeks dosing.

Topical JAK inhibitors, such as ruxolitinib (Opzelura), delgocitinib and tofacitinib have also entered the mild-moderate arena as they do relieve the itch of atopic dermatitis. However, systemic exposure leads to side effects, and they have been black boxed in USA because of serious infections, blood clots, low blood cell counts, diarrhea, itching and redness at application site. They cannot be applied to more than 20% of the body surface area but show a 43% efficacy after 8 weeks dosing.

Therefore, there is an unmet medical need for a safe efficacious medicine that treats mild to moderate eczema, particularly in infants and young children, with the opportunity to expand into severe eczema. In addition, new therapies will need to have a significantly improved safety profile compared to current standards of care and which allows them to be deployed for long term treatment in mild to moderate disease.

Carocell Bio’s Lead Candidate Treatment

JEL0305 as a topical formulation (cream) is expected to overcome the first line treatment for eczema because of safety and efficacy. Carocell Bio’s novel peptide technology will revolutionise the management of mild-moderate eczema.

Carocell Bio has shown, in human cellar models, that our lead peptide, JEL0305, can significantly reduce markers of inflammation such as TNF-a, IL-1b and IL-6 (Figures 1 and 2). We have also shown similar effects in human AD biopsy studies similar, if not better than, a comparative steroid (Figure 3). In addition, histological (microscope) studies after 3 treatments show significant improvement in skin architecture better than the comparative steroid (Figure 3).

AD1
Figure 1: Cells were dosed with JEL0305, left for 6 hours and then stimulated with LPS. TNF-⍺ is a pro-inflammatory cytokine that is a recognized marker of inflammation
Figure 2: JEL0305 not only “switches off” inflammation (as measured by TNF-⍺ levels) it also prevents the reaction of inflammation by blocking the positive feedback
AD3
Figure 3: Human AD biopsies dosed for 3 consecutive days with JEL0305 (or steroid or placebo)

A Clear Market Opportunity

The global eczema market is poised for exceptional growth at approximately 24.1% CAGR during the projection period (2025-2030) (1). Tens of millions of people continue to be affected by this debilitating skin ailment which in turn escalates the development of new pharmaceutical drugs. The current treatments for atopic dermatitis carry significant safety risks, which limit their application to mainly moderate-to-severe patients.

sales

Market research projects that the revenue pool of eczema market will exceed US$ 30 billion by 2030 (1)

References

  1. Globe Newswire, 2020
  2. Nutten S, 2015
  3. Eichenfield LF et al, 2014
  4. Shaw TE et al, 2011;
  5. Silverberg JI et al, 2015
  6. Hanifin JM et al, 2007
  7. Illi S, 2004
  8. Williams HC et al, 1998
  9. Ozkaya E, 2005
  10. Ellis CN et al, 2012
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OUR RESEARCH

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