Therapeutics Update

Cerave Introduces Three New Products

Cerave rolled out three new products during the American Academy of Dermatology’s annual meeting in San Diego. The brand’s new Hydrating Micellar Water cleanses and hydrates the skin while removing makeup‚with no rinsing necessary. It features niacinamide to help calm skin and hyaluronic acid to help skin retain its natural moisture and even carries the National Eczema Association Seal of Acceptance. Cerave also launched a new Psoriasis Moisturizing Cream and Cleanser, both with joint-friendly applicators. The gentle cream features salicylic acid that helps relieve skin itching, redness, flaking, and irritation, plus niacinamide to help calm skin. The cleanser boasts salicylic acid that helps relieve skin itching, redness, flaking, and irritation plus lactic acid. Cerave.com

Eau Thermale Avène Mineral Light Mattifying Sunscreen Lotion SPF 50+

May is Skin Cancer Awareness month, which often heralds a host of new products designed to protect the skin from the sun’s damaging rays. One of the first out of the gate in 2018 is the New Eau Thermale Avène Mineral Light Mattifying Sunscreen Lotion SPF 50+. The lotion offers 100% mineral broad-spectrum sun protection with titanium oxide and zinc oxide, while delivering oil control and providing a natural mattifying finish for oily and acne-prone skin. It’s lightweight, won’t clog pores, and contains powerful antioxidants to shield against damaging free radicals. Eau Thermale Avène Mineral Light Mattifying Sunscreen Lotion SPF 50+ is available at Aveneusa.com, and through dispensing physicians and authorized retailers nationwide. Aveneusa.com

Ducray Anacaps Activ+ Dietary Supplement

Ducray Anacaps Activ+ Dietary Supplement targets factors that trigger sudden hair loss, including seasonal changes, stress, diet, and post-pregnancy, and chronic hair loss, such as genetic, hormonal, and vascular causes, and weak or devitalized nails. Replete with zinc to nourish and revitalize hair follicles, molybdenum to strengthen hair’s keratin and provide antioxidant benefits, iron plus selenium and vitamin complex (Vitamins B2, B3, B5, B6 and B8 [Biotin], B9 and C & E), the supplement works synergistically to protect and optimize the functioning of the hair follicle. It’s recommended for use with other Ducray products and available via dispensing physicians. Ducray.com/en-us

Glytone Night Renewal Cream

Glytone’s newest product—Glytone Night Renewal Cream—is formulated for hyperpigmented and/or aging skin. Ingredients such as glycolic acid exfoliate dead cells as 05% Retinaldehyde, a non-irritating form of Vitamin A, helps to boost collagen production and improve elasticity of the skin for a more even skin tone. Glytone Night Renewal Cream is available at physician’s offices. Glytone-usa.com

Therapeutics Focus: Atopic Dermatitis

First Patient Dosed in Proof-of-Concept Trial of Topical by Design JAK Inhibitor SNA-125 for Atopic Dermatitis

The first patient has been dosed in Sienna Biopharmaceuticals, Inc.’s Phase 1/2 proof-of-concept clinical trial of topical product candidate SNA-125 in the treatment of atopic dermatitis and the associated pruritus. SNA-125 is designed to inhibit Janus kinase 3, or JAK3, and tropomyosin receptor kinase A, or TrkA, with minimal to no systemic exposure. JAK3 is a validated target in atopic dermatitis, psoriasis, and pruritus. JAK3 is required for immune cell development, and inhibiting JAK3 blocks the signaling of key cytokines, such as interleukin-4, or IL-4, IL-2 and tumor necrosis factor-alpha, or TNF-α, which results in a reduction in the severity of autoimmune and inflammatory diseases in which those cytokines play a pivotal role. TrkA is the high affinity receptor for nerve growth factor, or NGF, a known mediator of neurogenic inflammation and itch. This multicenter, randomized, double-blind, placebo- and comparator-controlled, intra-individual trial will evaluate the safety, tolerability and efficacy of SNA-125 compared to vehicle and other reference formulations in approximately 30 patients with atopic dermatitis.

“We are pleased to announce that we have now started our SNA-125 proof-of-concept trial for atopic dermatitis,” says Frederick C. Beddingfield III, MD, PhD, President and Chief Executive Officer of Sienna. “This is an important milestone for Sienna, firstly because we have executed on our plan to have five development programs in the clinic within the first half of this year, but also because we have entered an important phase of development for SNA-125, the second product candidate from our Topical by Design platform. Because SNA-125 comes from the Topical by Design™ platform, it is designed for highly localized delivery of the drug in the affected skin, with minimal to no systemic exposure. We believe SNA-125 has the potential to be a best-in-class, safe and effective, chronic topical treatment option for atopic dermatitis and look forward to the results from this trial, which we expect to report in the fourth quarter of 2018.”

“Atopic dermatitis is highly prevalent in the United States, dramatically more so than psoriasis,” said Emma Guttman, MD, PhD, Sol and Clara Kest professor of dermatology, vice chair, department of dermatology, Icahn School of Medicine at Mount Sinai and inaugural member of Sienna’s Corporate Advisory Board. “The vast majority of atopic dermatitis patients are children, and parents are highly concerned about side effects from steroid use. Despite new products coming to market for atopic dermatitis, there remains a significant unmet medical need for well-tolerated, safe and effective, non-steroidal treatment options for this population.”

“In this proof-of-concept trial, we are using the validated bilateral atopic dermatitis lesion assay to gain early clinical insight into the safety, tolerability and efficacy of SNA-125 as a topical treatment for atopic dermatitis,” said Paul F. Lizzul, MD, PhD, Chief Medical Officer of Sienna. “There is clear evidence that JAK3 inhibition can significantly reduce the severity of atopic dermatitis and the associated itch. We have demonstrated nonclinically that SNA-125 can meaningfully inhibit JAK3 and other important inflammatory signaling mediators. Now, we are eager to learn and understand how SNA-125 may impact atopic dermatitis patients clinically.”

YouTube AD Videos Unreliable

Perhaps no surprise to dermatologists, new research reveals that one-third of YouTube videos about atopic dermatitis contain misleading information. That’s according to researchers from the University of Texas Health Science Center in Houston who reviewed 128 YouTube videos about atopic dermatitis.

The majority of misleading videos were uploaded by advertisers, for-profit companies, and individuals who were not health care providers. On the bright side: Universities/professional organizations, government/news agencies and health care providers did not upload any misleading videos.

Findings from the cross-sectional study appear in the March edition of the Journal of the American Academy of Dermatology.

Newborn Skin May Pave the Way Toward New Eczema Lotion

Newborns emerge from the womb covered with a waxy substance called the vernix, which protects their skin from drying, and researchers have begun to realize that the vernix also helps babies adapt to life outside the womb by stimulating cells in the skin to make water-resistant lipid molecules.

Scientists at Leiden University in the Netherlands, led by Joke Bouwstra, a professor of Drug Delivery, Skin Research Group, at the Division of Drug Delivery Technology, thought it might be possible to harness the vernix to treat adults with skin problems. They formulated a lotion based on lipids found in the vernix and tested it on the skin of healthy volunteers.

In a study in the Journal of Lipid Research, the researchers showed that disrupting the water barrier on healthy volunteers’ arms using tape caused a change in the lipids that make up the barrier. With the new, shorter-chain lipids, more water could escape through the damaged skin. Applying the lotion sped up recovery by returning the lipid profile to normal. The researchers found changes to the synthesis of lipids that were not included in the lotion, suggesting that the lotion could mimic the vernix by changing how the skin makes lipids.

The researchers have not yet determined which ingredient drives the changes, but the lotion, or one similar to it, might someday help treat itchy skin rashes like eczema that are driven by irritants crossing a broken skin barrier.

Research Shines Light on Why People Experience AD in Winter

New research shows that the skin barrier is affected by climatic and seasonal changes.

In tests of skin on 80 adults, the levels of breakdown products of filaggrin changed between winter and summer on the cheeks and hands. Changes were also seen regarding the texture of corneocytes, the study showed.

“Both children and adults suffer from red cheeks in the winter in northern latitudes and some may even develop more permanent skin conditions such as atopic eczema and rosacea,” said senior author Jacob Thyssen, MD, PhD, DmSci of the University of Copenhagen in Denmark. “By the use of high magnification we show that the skin cells suffer from shrinkage and therefore change their surface. The clinical message to individuals are that they should protect their skin with emollients in the winter and sunscreen in the summer.

The findings appear in The British Journal of Dermatology.

WATCH THIS NOW

Combatting Steroid Phobia When Treating AD

“While corticosteroids are one of our most important options, there is a lot of baggage with these and there’s a lot of fear. So this term ‘corticosteroid phobia’ is a very real issue and unfortunately I think it is increasing...Families sometimes come in and say ‘We have this skin condition but don’t you dare prescribe steroids—we’re not going to use them.’ And that’s really difficult for us because, as we said, this is one of our most important treatments. So trying to teach around that and explain a couple of different things to the patient, one thing I like to say is ‘We’re going to use this very carefully. We’re going to really monitor closely the amount of time we’re going to be using it, and the duration and the body areas. we’re going to carefully keep an eye on that to make sure it’s not being misused.’ The other peice is using some of these nonsteroidal options...” explains Peter A. Lio, MD.

Menlo Therapeutics Announces Results from a Phase 2 Trial of Serlopitant for Pruritus Associated with AD

Menlo Therapeutics Inc., a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus associated with various underlying dermatologic conditions and for the treatment of refractory chronic cough, shared top-line results from MTI-103 (ATOMIK), the Phase 2 clinical trial of serlopitant for the treatment of pruritus in adults and adolescents with a history of atopic dermatitis (AD). The study did not meet its primary or key secondary efficacy endpoints with no statistically significant difference demonstrated between the serlopitant treated groups and the placebo treated group. Numerical differences favoring the serlopitant treated group were evident at all timepoints. Serlopitant was well-tolerated in this study.

“While we are disappointed that the results in this Phase 2 trial of pruritus associated with atopic dermatitis did not reach statistical significance and did not show the same magnitude of treatment effect as in our prior pruritus studies, we do see in the results a pattern that shows numerical improvement in each serlopitant treatment group above the placebo group at every timepoint. This is our third pruritus study of serlopitant. Reduction of pruritus has been demonstrated in two prior Phase 2 studies, one trial in patients with chronic pruritus and one trial in patients with prurigo nodularis,” stated Steve Basta, Chief Executive Officer of Menlo Therapeutics. “We are initiating Phase 3 studies in prurigo nodularis this quarter, and we are looking forward to the Phase 2 results in refractory chronic cough in the fourth quarter of this year, and the Phase 2 results in pruritus associated with psoriasis by late 2018 or early 2019.”

Serlopitant was well-tolerated in this study. No serious adverse events were assessed as likely related to serlopitant.

The ATOMIK, MTI-103 study, was a multi-center, randomized, placebo-controlled Phase 2 clinical trial conducted at 52 US sites to assess the efficacy, safety and tolerability of serlopitant. The study enrolled 484 subjects ages 13 years of age and older with a past or present diagnosis of atopic dermatitis, pruritus for at least six weeks, and an average weekly worst-itch numeric rating scale, or WI-NRS score ≥ 6 for each of the two weeks of the screening period, as recorded in the eDiary. Patients were randomized into one of three treatment arms: once-daily doses of placebo, 1mg serlopitant, or 5mg serlopitant. The trial included a two-week screening period, a six-week treatment period and a four-week follow-up period. This trial was intended to evaluate if treatment with either 5mg or 1mg serlopitant daily for six weeks could reduce pruritus associated with atopic dermatitis compared with placebo. The primary efficacy analysis compared the difference between serlopitant and placebo in the mean change in WI-NRS from baseline to week six. A key secondary endpoint was a responder-rate analysis of a 4-point WI-NRS improvement at week six.