Recent Developments

Eating Grapes May Protect Skin From UV Damage

Consuming grapes can protect against ultraviolet (UV) damage to the skin, according to a new study in Antioxidants. Study participants showed increased resistance to sunburn after consuming 2.25 cups of grapes every day for 2 weeks. Additionally, subjects displaying UV resistance demonstrated unique microbiomic and metabolomic profiles, suggesting a correlation between the gut and skin.

Polyphenols found in grapes are thought to be responsible for these beneficial effects, the study authors conclude.

In the study of 29 people, researchers examined the impact of consuming whole grape powder—equivalent to 2.25 cups of grapes per day—for 14 days against photodamage from UV light. Subjects’ skin response to UV light was measured before and after consuming grapes for 2 weeks by determining the threshold dose of UV radiation that induced visible reddening after 24 hours—the Minimal Erythema Dose (MED). Additionally, metabolomic analysis of the gut microbiome, blood, and urinary samples was undertaken.

One-third of the subjects demonstrated UV resistance following grape consumption, and these same subjects displayed significant differences in the microbiome and metabolome compared with the non-responders. The same three urinary metabolites were depressed in the UV-resistant group, the study showed. One metabolite (2’-deoxyribose) is a strong indicator of reduced photodamage and suggests unique genetic profiles of relevance for personalized medicine.

Three of the UV resistant subjects showed a durable response where UV protection remained after reverting back to no grape consumption for 4 more weeks. This work suggests that a segment of the population is capable of resisting sunburn following grape consumption, and that there is a correlation between the gut-skin axis and UV resistance.

EBRP Presents Third Annual Venture Into Cures

EB Research Partnership (EBRP) presented the third annual Venture Into Cures, an inspiring virtual event featuring moving stories about individuals and families living with Epidermolysis Bullosa (EB). Co-founders Eddie and Jill Vedder, along with their daughters Olivia and Harper Vedder, were joined by a lineup of celebrity friends and guests to raise more than $1.3 million for EBRP, bringing the 3-year total raised via Venture Into Cures to more than $6 million, moving the organization closer to finding a cure for EB and leading the way for other rare diseases.

More than 75,000 people tuned in from over 70 countries to watch the special that included appearances and performances by Jonathan Brown, Dana Carvey, Billie Eilish, Will Ferrell, FINNEAS, Jack Harlow, Tom Holland, Joe Jonas, Kermit the Frog, John Legend, Macklemore, Lamorne Morris, Joy Oladokun, Red Hot Chili Peppers, Chris Pratt, Keanu Reeves, Olivia Rodrigo, Broken Social Scene, Molly Shannon, Hannah Simone, David Spade, Lauren Spencer-Smith, The Vedder Family, Emma Watson, Venus Willams, and more.

The 1-hour virtual show was produced by EBRP and Door Knocker Media, with artist booking by one twenty eight. Watch the replay stream of Venture Into Cures at https://www.youtube.com/watch?v=6DPxsVlofwA

“With our third annual Venture Into Cures event wrapped, we cannot begin to express our gratitude for those involved in this incredible show,” says Jill Vedder, EBRP co-founder, in a news release. “From the exceptional talent who offered their time and voice, through to the generous donors that continue to show up for the EB community, we are immensely grateful as we move closer to finding a cure for EB.”

“Through the ongoing support of the Venture Into Cures’ audience, donors and the patient and medical communities, we will continue to fund the most innovative and impactful global research. Over the last 10 years, EBRP has made incredible strides in research and clinical trials. From the resiliency of the families and the commitment of scientists, together our ambitious goal is to cure EB in this decade,” adds Eddie Vedder, musician and EBRP co-founder.

Co-Founded by a dedicated group of parents, along with Jill and Eddie Vedder, as the largest global organization supporting EB research, EBRP has funded more than 120 projects through their innovative model, directly impacting the clinical landscape. Through EBRP’s work, clinical trials for EB have increased by nearly 20 times, from two to nearly 40, including four Phase 3 clinical trials, the final phase before the FDA considers approval for a new therapy.

Bimekizumab Demonstrated Sustained Clinical Responses to Week 52

Bimekizumab demonstrated sustained clinical responses to Week 52 in Phase 3 studies in psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

The findings were presented at the ACR Convergence 2022 in Philadelphia, November 10–14, 2022.

In BE OPTIMAL, clinical joint and skin clearance responses in psoriatic arthritis were sustained to week 52 with bimekizumab treatment. In BE MOBILE 1 and BE MOBILE 2, treatment with bimekizumab resulted in sustained clinical responses to week 52, including suppression of inflammation and improvements in function and quality of life across the full spectrum of axial spondyloarthritis

The adverse event profile of bimekizumab to week 52 in psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis is consistent with previous observations with no new safety signals, the study showed.

The safety and efficacy of bimekizumab in PsA, nr-axSpA and AS have not been established, and it is not approved for use in PsA, nr-axSpA or AS by any regulatory authority worldwide.

Data from BE OPTIMAL showed that clinical joint and skin clearance responses in patients with active psoriatic arthritis were sustained to week 52 with bimekizumab treatment. In addition, data from BE MOBILE 1 and BE MOBILE 2, showed that across the full spectrum of axSpA, encompassing nr-axSpA and AS, treatment with bimekizumab resulted in sustained improvement in the signs and symptoms of disease, including suppression of inflammation and improvements in physical function and quality of life, to week 52. These outcomes were consistent across both TNF-inhibitor (TNFi) naïve and TNFi-inadequate responder populations. In all three studies, the adverse event profile of bimekizumab was consistent with data seen in previous studies with no new observed signals.

“The 52-week data shared today demonstrate the high thresholds of disease control that were achieved by the majority of patients across these three studies. The results build on the previously announced 24-week data and show that bimekizumab sustained a clinically meaningful impact for patients through one year,” says Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB, in a news release.

Dermavant Launches First Commercial for VTAMA

Dermavant Sciences launched its first commercial as part of a national, multimedia, direct-to-consumer advertising campaign for Vtama (tapinarof) cream 1%.

Inspired by the stories of real patients, the “Topical Uprising” campaign focuses on the patient journey—tapping into the frustrations of living with plaque psoriasis and helping to empower adult patients to demand more from their topical prescription medications.

“When developing this campaign, we felt it was critical to show the daily trials and tribulations of plaque psoriasis patients, many of whom have struggled with managing their symptoms and the emotional burden that comes with it,” says Todd Zavodnick, Chief Executive Officer of Dermavant, in a news release. “Living with plaque psoriasis can unfortunately be frustrating. In this campaign, we wanted to convey how the condition really feels—a predicament we have the utmost empathy for—while highlighting to patients that they’re not alone, and finally giving them the tools they need to help feel empowered in their treatment journey. Many have been waiting a long time for a different plaque psoriasis treatment like VTAMA cream.”

The campaign follows the FDA’s approval of VTAMA cream in May 2022 for adults with mild, moderate, and severe plaque psoriasis with no label restrictions on duration of use or body surface area. The approval made VTAMA cream the first topical novel chemical entity launched for psoriasis in the US in 25 years.

Alphyn Biologics Completes First Cohort of Phase 2a Clinical Trial of Topical Therapy for AD

Alphyn Biologics completed the first cohort of its Phase 2a clinical trial of AB-101a, a topical therapeutic candidate for mild to moderate atopic dermatitis (AD) in adults and children as young as 2 years old.

The first cohort enrolled AD patients without bacterial infection, which is sometimes associated with the disease.

Top-line results are expected in approximately 8 weeks.

AB-101a was developed using Alphyn’s proprietary AB-101 platform. The platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to potentially address multiple problems of any target disease. Alphyn began its clinical trial program in Phase 2 due to the strong safety profile of its AB-101 platform.

The randomized, vehicle-controlled, double-blind trial is evaluating the treatment protocol of AB-101a across multiple sites using standard scales for assessing AD. Enrollment is ongoing in a second cohort of the trial, which uniquely is investigating the treatment in AD patients who are also suffering from bacterial infections, including Staphylococcus aureus, or Staph, and MRSA, the antibiotic-resistant Staph. Alphyn anticipates AB-101a will be effective against non-infected AD and infected AD and expects it will offer patients and physicians a comprehensive, safe, and convenient treatment option.

Phase 3 Results: Reistone Biopharma’s Oral Ivarmacitinib Meets Primary Endpoint for AD

Reistone Biopharma’s once daily Ivarmacitinib as monotherapy relieves skin inflammation and itchiness in adults and adolescents with moderate to severe atopic dermatitis, according to a results from the Phase 3 QUARTZ3 study.

The study evaluated the efficacy and safety of once daily Ivarmacitinib as monotherapy in adults and adolescents with moderate to severe atopic dermatitis (AD). Two doses (8mg QD or 4mg QD) met the co-primary endpoints, demonstrating significantly improved IGA 0/1 response rate and EASI 75 response rate versus placebo at week 16. Ivarmacitinib was well-tolerated at both doses without new safety findings.

Ivarmacitinib tablet is highly selective Janus kinase type 1 (JAK1) inhibitor developed by Reistone and Jiangsu Hengrui for oral use. Several late-stage clinical studies are on-going with both oral and topical dosage forms for several immune-inflammatory diseases including Ulcerative Colitis, Alopecia Areata, Crohn’s Disease, etc. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors. Ivarmacitinib tablet is the first National Class A new drug for atopic dermatitis designed and developed in China. In January 2021, based on its Phase 2 results in the patients of atopic dermatitis, Ivarmacitinib was designated as Breakthrough Therapeutic Drug (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). Ivarmacitinib is the first domestically developed JAK1 inhibitor to successfully achieve a pivotal Phase 3 study in atopic dermatitis.

Reistone Biopharma plans to communicate with the national regulatory authority about the new drug marketing application (NDA) as soon as possible. Ivarmacitinib is expected to be marketed first in China, providing an innovative drug choice for the Chinese patients with atopic dermatitis.

Close Up with Shane Sakamaki-Ching and Prue Talbot

The dangers of first- and second-hand tobacco smoke are well known, but less is understood about the hazards of third-hand smoke, especially on the skin. This is why Shane Sakamaki-Ching, a former graduate student, and Prue Talbot, a professor of cell biology at the University of California (UC)-Riverside, took a deeper dive into the matter. They found that dermal thirdhand smoke exposure can kickstart the inflammatory process seen in skin diseases, such as contact dermatitis and psoriasis. They chatted with Practical Dermatology® magazine about the results of their recent study whoosh appeared in the October 2022 issue of eBioMedicine.

Why is this topic important to study?

Shane Sakamaki-Ching and Prue Talbot: Thirdhand smoke (THS), which is the residual chemical contamination from cigarette smoke that settles on indoor surfaces once smoking has stopped, is harmful to human health. There are currently more than 1 billion cigarette users in the world, and they may not be aware of the health effects of THS. For example, if they lived with smokers, bought a used car owned by a previous smoker, or visited a casino, they are putting their health at risk. We need more information on human health effects produced by THS to protect non-smokers and enact better regulatory policies.

Describe the research and your findings.

Sakamaki-Ching and Talbot: This was a collaborative research project between UC Riverside, UC San Francisco, and UC Davis, in which a clinical research investigation was performed using healthy human participants who were dermally exposed to THS while wearing cotton clothing that was exposed to either filtered clean air or cigarette smoke for up to 6 months. The healthy participants wore the cotton clothing and exercised on a treadmill for 15 mins/hour for a total of 3 hours, then 20-30 days later repeated the exposure wearing the opposite clothing. Urine and blood, from which plasma was isolated, were collected at specific times up to 22 hours. Biomarkers of harm and proteomics analysis were performed to determine the biological responses to dermal THS exposure.

For the first time, we demonstrated that dermal THS exposure can initiate the molecular biomarkers of inflammatory skin diseases, such as contact dermatitis and psoriasis. Also, dermal thirdhand smoke exposure elevated oxidative stress, which can lead to diseases such as cancer, heart disease, and atherosclerosis. These findings demonstrate that dermal exposure to thirdhand smoke is potentially harmful to humans and can initiate the mechanisms of diseases, even after acute exposure.

What is your next step?

Sakamaki-Ching and Talbot: Future studies will evaluate larger human populations for longer periods of exposure to further characterize chronic human health responses to dermal THS exposure. Electronic cigarette residue that deposits on indoor surfaces and comes into contact with human skin will also be studied.