Innovation Sparks Advancement of New Treatments for Atopic Dermatitis
Published Thursday, January 07, 2016 by Fred Zucker
Even though the root cause of atopic dermatitis (AD), or eczema, remains a mystery, this is an exciting time in the dermatology space with innovation driving substantial advancements for the first time in decades.  As Peter Lio, MD, assistant professor of clinical dermatology and pediatrics-dermatology at Northwestern University Feinberg School of Medicine, explained in the October edition of The Dermatologist, part of the challenge rests in the fact that a range of factors play a role in the immunopathogenesis of AD, a chronic, itchy inflammation of the skin that can range from mild to severe.

Addressing the dynamics and prominence of AD is a prime initiative of companies like Oculus Innovative Sciences (NASDAQ: OCLS) and Vitae Pharmaceuticals (NASDAQ: VTAE).  The AD business is forecast to experience significant growth in the next 10 years and a company with safe and effective products could be part and parcel to the expansion.  Aquinox Pharmaceuticals (NASDAQ: AQXP) was hoping to capitalize on the opportunity, but last month disclosed that its Phase 2 trial of AQX-1125 in AD patients missed its primary endpoint, resulting in Aquinox deciding to discontinue the program.

AD, which most often presents in infants and children, accounts for up to 20 percent of all referrals to dermatologists.  More than 10 percent of all infants and young children are affected by AD and about 60 percent of those people continue to have some symptom of AD in adulthood, equating to in excess of 15 million people in the U.S. feeling some symptom of the disease.

According to research and consulting firm GlobalData, the global atopic dermatitis treatment market will more than double in value from $3.6 billion in 2014 to an estimated $7.3 billion by 2024.  In line with comments of Dr. Lio, GlobalData sees new drugs coming to market as one of the catalysts for the growth as better alternatives in a saturated generics market.

Oculus Innovative Sciences was also mentioned in the October edition of The Dermatologist because of its recent FDA approvals of Alevicyn Antipruritic Gel and Alevicyn Antipruritic SG (spray gel).  Antipruritics, which can include antihistamines and corticosteroids, have been difficult for the industry to successfully advance due in part to side effects, especially with corticosteroids.  Oculus broke through this problem with topical solutions that were approved as non-steroidal, antipruritic products utilizing the company’s Microcyn Technology to manage and relieve the burning, itching and pain experienced with several types of dermatoses, including atopic dermatitis and radiation dermatitis.

The efficacy and safety of the Microcyn-based technologies is centered on the principles of hypochlorous acid, an antimicrobial solution produced by the body to fight invading pathogens.  The scope of hypochlorous acid activity is wide, as it is also known to rapidly destroy many resistant pathogens, including MRSA, E.coli, HIV, and the avian influenza virus, to name a few.

Employing a patented electrochemical manufacturing process, Oculus creates a pH neutral solution of hypochlorous acid and its sodium salt called hypochlorite.  The recently approved Alevicyn products for dermatoses join a portfolio of Microcyn-based products used in advanced wound management and animal healthcare.  Because Alevicyn products are water-based, they create a moist environment to treat the skin barrier function and rehydrate the skin.  Importantly, across more than 30 clinical trials and thousands of applications, there are zero known serious adverse events and no interactions or contraindications with the Microcyn-based products.

The most recent Alevicyn AD products were launched in the third quarter.  Oculus didn’t break down sales of their products during the recent quarter, but total product sales in the U.S. were up a strong 233 percent year-over-year to $1.2 million for the quarter.  Look for rising sales figures in coming quarters as the company’s sales team continues to ramp introduction to dermatologists.

Vitae Pharmaceuticals announced recently that it began dosing patients in a Phase 2a clinical study evaluating the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of VTP-38543, a topical LXR (liver X receptor) selective agonist, in patients with mild to moderate AD.  The four-week, approximately 100 patient study is a jump in developmental pathway, as Vitae originally was planning to start clinical work on VTP-38543, which has yet to be tested on a human, for the indication in a Phase 1 trial.  Top-line results from this trial are expected in the second half of 2016.

Vitae, who is pre-revenue and most advanced product is in a Phase 2 trial for Type 2 diabetes, is looking to assess the ability of its compound to activate LXR in skin keratinocytes, the predominant cell type in the outer layer of the skin, constituting about 90 percent of the cells in the epidermis.  Activating these cells in lab studies showed increase formation of corneocytes (which comprise most of the stratum corneum, or portion of the skin that touches the environment) and lamellar lipids (another unique and essential component of the stratum corneum).  LXR activation has also been shown to reduce inflammation in the skin to a similar level as a high potency corticosteroid.  By repairing damage and reducing inflammation, two key components of AD, Vitae hopes to improve outcomes in AD patients.

Vanda Pharmaceuticals (NASDAQ:VNDA) is also worth mentioning in the AD drug development space.  The company is generating revenue with other products, but hit a setback in the first quarter this year in development of tradipitant, a neurokinin 1 receptor antagonist being developed for chronic pruritus in patients with AD.  A meaningful improvement on the 100mm unit Visual Analog Scale for itch was shown, but a large placebo effect was too, resulting in no statistically significant improvement for the drug compared to placebo.  Additional pharmacokinetic analysis showed a strong correlation between outcomes and patients with higher exposure to tradipitant, leaving interested parties as to what the developmental path holds for tradipitant going forward.

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