The Clinical Need and Market Opportunity in Atopic Dermatitis

Certain aspects of Brilacidin’s Mechanism of Action (MOA) as a defensin-mimetic may make it well-suited to treat Atopic Dermatitis (AD) (eczema) as a topical medication (formulation planning is underway), including its anti-bacterial properties as well as how it may also function to help restore balance in the skin microbiome.

Staph Aureus and Atopic Dermatitis

The first-in-class immunomodulatory drug candidate, which is modeled on the body’s natural Host Defense response, is potent in killing infection-causing "bad" bacteria, such as Staphylococcus aureus (S. aureus), including Methicillin-resistant Staphylococcus aureus (MRSA). Brilacidin compared favorably to Daptomycin in a completed Phase 2b clinical trial in Acute Bacterial Skin and Skin Structure Infection (ABSSSI). S. aureus colonization of the skin is highly over-expressed in AD, present in up to 70 percent of active lesions, and 39 percent of nonlesional skin, according to a July 2016 study published in the British Journal of Dermatology.

The paper’s conclusion:

[T]his systematic review and meta-analysis demonstrates that patients with AD are more frequently colonized with S. aureus than healthy controls and that colonization is increased in more severe AD. These results provide an indication of the importance of colonization as a factor in the pathogenesis of AD and encourage evaluation of targeted antistaphylococcal therapy for the skin (and nose) […]

Modulating the Skin's Host Defense

Brilacidin may also work to modify the skin's native microbiome in a beneficial way, helping to maintain a more natural skin homeostasis, particularly in conditions where there may be defective antimicrobial peptide (AMP) production and dysfunctional Host Defense response. Clinical research in this area, independent of Brilacidin, is being conducted by Dr. Richard Gallo and his lab at the University of California San Diego, with their work recently profiled in the New York Times. Dr. Gallo is a leading expert in innate immunity in the skin and how antimicrobial peptides play a key role in skin disease (pdf).

Eczema Market Opportunity

Eczema represents a large market opportunity, affecting up to a combined 50 million people in the U.S. and major European markets, detrimentally impacting AD sufferers quality of life and workplace productivity. Like in psoriasis, AD patients experience high rates of anxiety, depression and sleep disorders. An article in the June 2017 Journal of the American Academy of Dermatology concluded: "AD is associated with a substantial humanistic burden that is similar in magnitude to that of psoriasis, which is also recognized for its debilitating symptoms, indicating the need for more effective treatments for AD."

Sanofi’s and Regeneron’s Dupixent (dupilumab), which was approved by the Food and Drug Administration (FDA) in March 2017 (label, pdf), is estimated to achieve peak annual sales of $4 billion. Pfizer’s Eucrisa (crisaborole), which was acquired for $5.2 billion in a merger with Anacor and approved by the FDA in December 2016, is estimated to achieve peak annual sales of $2 billion. The majority of its target market is expected to comprise mild-to-moderate cases, with up to ~60 percent pediatric and adolescent patients.

Building on promising interim results of Brilacidin in treating Inflammatory Bowel Disease and in preventing Oral Mucositis, Innovation Pharma continues to research Brilacidin's potential application in various dermatological indications given the important role defensins play in regulating skin micro-environments.

Source: http://www.mdpi.com/1422-0067/15/5/8753/htm

Source: http://www.mdpi.com/1422-0067/15/5/8753/htm

Source: http://www.jaad.org/article/S0190-9622(17)30506-6/fulltext

In patients with AD, recurrent infections with S. aureus are a significant problem contributing to disease flare, driving both tissue damage and inflammation. Current therapy is reactive, but management should include early and proactive intervention with effective, continuous control of S. aureus colonization.
— Source: “The complex biology and contribution of Staphylococcus aureus in atopic dermatitis, current and future therapies.” Review Article. British Journal of Dermatology. Volume 177, Issue 1 July 2017 Pages 63–71. http://onlinelibrary.wiley.com/doi/10.1111/bjd.15139/full