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Marie Bosslett is the assistant editor of 

 and joined the MJH Life Sciences team in October 2024. She attended Loyola University Maryland in Baltimore and earned a Bachelor of Arts in Communication with minors in marketing and writing. When she’s not writing, Marie enjoys going to concerts, reading on the beach, and spending time with friends and family.

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In case you missed it, this week we had news about Clinuvel's phase III trial enrollment for vitiligo, Sun Pharma's BLU-U device for actinic keratosis, a botanical-based nutraceutical for acne patients and more.

The Weekly Roundup: May 12-16

Maddi Hebebrand is an associate editor of 

and joined the MJH Life Sciences team in May 2024. She attended Baldwin Wallace University, studying Media Production and Film, and received her Masters in Digital Media from Ohio University. When she's not writing, Maddi loves to read, attend concerts and spend time with her family. 

This week, we feature top articles from our sister publications on regulatory updates, clinical trial insights, and more.

The Rx Recap: May 11-17

and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

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A presentation from the 2021 virtual American Academy of Pediatrics Conference & Exhibition urges including examination of the scalp and nails during any skin exam.

Looking at the scalp and nails during a skin exam is key

Final Thoughts: The Importance of Comparative Studies in AD

Panelists offer concluding insights and emphasize the critical role of comparative studies in advancing atopic dermatitis treatment strategies.

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Hyperhidrosis is not rare. According to the 

, approximately 385 million people worldwide live with hyperhidrosis.

In fact, they note that the amount of people living with chronic, excessive sweating is even higher than the amount of people living with other dermatologic conditions like psoriasis.

Just how common is hyperhidrosis in real-world comparisons?

The prevalence of hyperhidrosis is much higher in younger populations than in the general population, with 8.8% of individuals between the ages of 18 to 39 years old living with the condition. 

When comparing these statistics to everyday, common occurrences like hair color, the number of people with hyperhidrosis is greater than the 1% of individuals with natural red hair and 2% of individuals with natural blond hair. 

Despite how common hyperhidrosis is, it is estimated that 27% of those with the condition never receive a diagnosis.

 wants to hear from you. What percentage of the global population is estimated to have hyperhidrosis?

 to share your hyperhidrosis insights or research.

Albert. Fact check: Hyperhidrosis - International Hyperhidrosis Society: Official site. Home - International Hyperhidrosis Society. October 24, 1970. Accessed November 16, 2023. 

https://www.sweathelp.org/home/news-blog/542-fact-check-hyperhidrosis.html

Hyperhidrosis affects approximately 385 million people globally, surpassing the prevalence of other dermatologic conditions like psoriasis. It is notably more common in younger populations, with 8.8% of individuals aged 18 to 39 experiencing the condition. Comparatively, hyperhidrosis is more prevalent than natural red or blond hair, which affects 1% and 2% of the population, respectively. Despite its prevalence, 27% of those with hyperhidrosis remain undiagnosed. The article encourages engagement during Hyperhidrosis Awareness Month to share insights and research on the condition.

Click here to answer this week's poll for Hyperhidrosis Awareness Month.

Polls 

POLL: What Percent of the Global Population is Estimated to Have Hyperhidrosis?

At the recent Society for Investigative Dermatology Annual Meeting, researchers shared new data demonstrating that TRIV-509, a novel monoclonal antibody targeting the serine proteases KLK5 and KLK7, may offer a rapid and effective therapeutic approach for atopic dermatitis (AD).

 The findings, presented in a poster highlight a promising avenue for restoring skin barrier integrity and reducing inflammation in patients.

Increasing evidence links dysregulation of epidermal serine proteases to the pathogenesis of AD, with KLK5 and KLK7, or kallikrein-related peptidases, playing pivotal roles.

 These enzymes are typically involved in skin desquamation but are overexpressed and hyperactive in atopic skin, leading to excessive degradation of critical barrier proteins such as desmoglein-1 (DSG1) and other structural components.

 Furthermore, variations that lead to increased KLK activity correlate with heightened susceptibility to AD and asthma.

The investigation involved collecting skin biopsies from 3 patients with clinically diagnosed AD, characterized by an Investigator Global Assessment (IGA) score greater than 2, indicative of moderate to severe disease activity. The experimental setup involved treating these biopsies with TRIV-509 or control IgG ex vivo.

The biopsies underwent treatment with 25 µg/mL of TRIV-509 for a period of 72 hours, with media changed at 48 hours and treatment renewed for an additional 24 hours. Subsequently, the tissues were processed for various analyses, including histological staining and immunohistochemistry, to assess changes in epidermal thickness, keratinocyte proliferation, and the expression of key structural proteins like DSG1.

One of the primary outcomes was a significant decrease in epidermal hyperplasia. In 2 patients, treatment with TRIV-509 resulted in a 14% to 28% reduction in epidermal thickness compared to control IgG. 

This reduction correlated with diminished keratinocyte proliferation, demonstrated by an approximately 80% decrease in Ki-67 positive basal layer cells, highlighting a substantial decrease in epidermal hyperproliferation.

TRIV-509 effectively mitigated parakeratosis, reducing abnormal nuclei layers in the stratum corneum by 31% in 1 of the patients. Additionally, histological evaluation revealed that the treatment restored the distribution and expression of DSG1 with a notable increase of up to 313% in DSG1+ cell counts in treated specimens. This suggests a rapid reestablishment of cell-cell adhesion and barrier function.

Further analyses demonstrated that TRIV-509 increased DSG1 expression in the epidermis, aligning it more closely with non-lesional skin. The treatment also reduced epidermal thickness and parakeratosis substantially, indicating improved epidermal differentiation and barrier integrity.

The findings presented at SID suggest that targeting KLK5 and KLK7 with an antibody such as TRIV-509 can rapidly reverse key features of the atopic epidermal phenotype. The therapy not only reduced hyperproliferation and keratinocyte turnover but also directly improves barrier integrity by restoring DSG1 levels.

Moving forward, researchers plan to evaluate TRIV-509 in clinical trials, with a focus on skin barrier improvements, symptom alleviation, and quality-of-life outcomes for patients with AD. The data also encourage further exploration into protease-targeted therapies for other barrier-related skin conditions.

Mateer E, Asp E, e Sousa MS, et al. TRIV-509, a dual inhibitor of KLK5 and KLK7, rapidly improves barrier integrity and markers of epidermal differentiation in atopic dermatitis skin explants. Poster presented at: Society for Investigative Dermatology Annual Meeting; May 7-10; San Diego, California.

Kishibe M. Physiological and pathological roles of kallikrein-related peptidases in the epidermis. 

Elias PM. Therapeutic implications of a barrier-based pathogenesis of atopic dermatitis. 

TRIV-509, a novel monoclonal antibody targeting serine proteases KLK5 and KLK7, shows promise as a rapid and effective treatment for atopic dermatitis (AD). By inhibiting these enzymes, TRIV-509 reduces epidermal hyperplasia, keratinocyte proliferation, and parakeratosis, while restoring DSG1 expression and skin barrier integrity. The study involved ex vivo treatment of skin biopsies from AD patients, demonstrating significant improvements in epidermal structure and function. Future clinical trials will focus on evaluating TRIV-509's impact on skin barrier improvements, symptom relief, and quality of life for AD patients.

Researchers reveal TRIV-509, a novel monoclonal antibody, shows promise in rapidly improving atopic dermatitis by restoring skin barrier integrity and reducing inflammation.

Dual Inhibitor TRIV-509 Shows Promise for Rapid Improvement in Atopic Dermatitis

Extended oral corticosteroid (OCS) therapy in patients with atopic dermatitis (AD)  is linked to heightened cardiovascular and thrombotic risks, including major adverse cardiovascular events (MACE) and venous thromboembolism (VTE), versus patients on short-term OCS therapy, according to a new study.

The study, presented in a poster at the Society for Investigative Dermatology Annual Meeting, May 7-10, 2025, in San Diego, California, suggests clinicians should critically evaluate the risk-benefit profile before prescribing long-term corticosteroids for AD management.

Historically, guidelines for OCS have advised caution due to potential adverse effects, including cardiovascular events and VTE.

 Yet, most evidence focused on populations with other immune-mediated diseases like rheumatoid arthritis or lupus,

leaving a significant knowledge gap about the safety profile in patients with AD specifically.

Recognizing this gap, researchers aimed to investigate the relationship between prolonged OCS use and MACE and VTE in individuals diagnosed with AD. The investigation employed a retrospective, observational cohort design utilizing the Optum Clinformatics Data Mart, a comprehensive US database that aggregates de-identified health claims data. The study population consisted of over 52,000 patients with a documented diagnosis of AD, aged 12 years and older, who initiated oral corticosteroid therapy during the study period.

Patients were categorized based on corticosteroid use patterns, including short-term use (a single prescription with a supply of ≤30 days or 2 prescriptions within 1 month) and prolonged use (1 or more prescriptions exceeding 30 days or multiple prescriptions with longer supply durations).

The study used a "clone-censor-weight" approach to emulate a hypothetical "per-protocol" trial, comparing the risks of MACE and VTE between the 2 groups over a 2-year follow-up.

The data revealed significant risks associated with long-term OCS therapy. 

The crude incidence of MACE was 3.07 events per 100 person-years in the prolonged-use group, compared to 2.62 in the short-term group. For VTE, the rates were 0.43 versus 0.16 per 100 person-years, respectively.

The cumulative probability of experiencing a vascular event over 2 years was higher in the prolonged group, with estimates around 4% versus 3% in the short-term group.

The cumulative risk for VTE markedly increased, with probabilities approximately 0.6% in prolonged users against 0.3% in short-term users.

After adjusting for baseline characteristics, prolonged corticosteroid use was associated with an 81% increase in VTE risk and a 24% higher risk of MACE.

Kaplan-Meier survival curves emphasized the divergence in event-free survival over time, reinforcing that extended steroid therapy correlates with a higher burden of cardiovascular and thrombotic events.

These findings align with guidelines cautioning against routine long-term steroid use but provide quantitative risk estimates specific to the AD population, according to poster authors Lebwohl et al.

Potential limitations to consider include the study's observational nature and residual confounding and a focus on a US population limiting potential generalizability, among other factors.

"Characterizing prolonged oral CS use and the associated cardiovascular and thrombotic risk among patients with AD may help inform treatment benefit-risk assessments," wrote Lebwohl et al.

Lebwohl M, Bunick C, Vleugels RA, et al. Cardiovascular and thrombosis risks of prolonged versus short-term use of oral corticosteroids among atopic dermatitis patients in the United States. Poster presented at: Society for Investigative Dermatology Annual Meeting; May 7-10; San Diego, California.

Yasir M, Goyal A, Sonthalia S. Corticosteroid Adverse Effects. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; July 3, 2023. 

https://www.ncbi.nlm.nih.gov/books/NBK531462/

Extended oral corticosteroid therapy in atopic dermatitis patients is linked to increased cardiovascular and thrombotic risks, including major adverse cardiovascular events (MACE) and venous thromboembolism (VTE), compared to short-term therapy. A study using a US health claims database found that prolonged corticosteroid use significantly raises the risk of these events. The study emphasizes the need for clinicians to carefully assess the risk-benefit profile of long-term corticosteroid use in atopic dermatitis management, considering the heightened risk of cardiovascular and thrombotic events.

Extended oral corticosteroid therapy in patients with atopic dermatitis significantly increases cardiovascular and thrombotic risks, urging careful treatment evaluations. 

Prolonged Use of Oral Corticosteroids in Atopic Dermatitis Linked to Increased Cardiovascular Risks

Corvus Pharmaceuticals recently announced

 new interim data for its randomized, double-blind, placebo-controlled phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis (AD) who have failed one prior topical or systemic therapy. The newest data demonstrated a favorable safety and efficacy profile, including earlier and deeper response in patients who received soquelitinib 200 mg twice daily (cohort 3), compared with patients who received soquelitinib 100 mg twice daily (cohort 1) and 200 mg once daily (cohort 2). According to the data, all 3 cohorts had significant responses among the groups treated with soquelitinib compared with placebo when evaluating end points of EASI 75 and IGA 0/1.

Soquelitinib is an investigational, small molecule oral therapeutic designed to selectively inhibit IL-2-inducible T cell kinase (ITK), an enzyme predominantly expressed in T cells and involved in T cell and natural killer (NK) cell immune function. According to initial data, soqeulitinib has demonstrated its ability to affect T cell differentiation and induce Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Corvus “believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases.”

Enrollment for all 3 cohorts concluded as of May 6, 2025, and included 48 total patients. The interim phase 1 data highlights 32 patients receiving soquelitinib and 12 patients receiving placebo with a 28-day follow-up, and 4 patients receiving soquelitinib with a 15-day follow-up from cohort 3. The 4 patients in cohort 3 have not completed their 28-day treatment.

“We continue to be encouraged by the results from our phase 1 trial of soquelitinib in patients with atopic dermatitis, which show a favorable safety and efficacy profile with a convenient oral tablet. We believe the results are particularly exciting given the relatively short treatment duration of 28 days and durable post-treatment results, both of which we associate with the novel mechanism of action provided by ITK inhibition,” said Richard A. Miller, MD, co-founder, president, and chief executive officer of Corvus Pharmaceuticals, in the news release.1

Miller continued, “This is supported by biomarker studies from the trial, which show evidence of multiple effects derived from the selective blockade of ITK including the reduction of various inflammatory cytokines and the potential induction of T regulatory cells, further amplifying the disease-modifying effects of soquelitinib. Based on these results, we have amended the trial protocol to evaluate an additional 24 patients at the 200 mg twice per day dose, randomized one-to-one with placebo for an extended treatment period of 8 weeks. This amendment gives us the opportunity to evaluate the potential for even stronger efficacy with longer treatment duration. This additional experience is intended to help optimize the design of a phase 2 trial, which we are on track to initiate before the end of the year.”

Current primary end points include safety and tolerability. Secondary end points include improvements in EASI scores and IGA to measure efficacy. Reduction in itch and various cytokine biomarkers are exploratory end points.

Patients in cohort 3 (n=16) had more severe disease with higher mean baseline EASI scores compared with patients in cohorts 1 (n=16) and 2 (n=16). A higher proportion of patients failed prior systemic therapies. Across the 3 cohorts, the mean EASI scores are 22.3 and 21.1 for active and placebo.

The percent reduction in mean EASI scores at 28 days for cohorts 1 and 2 combined was 54.6% for patients receiving soquelitinib and 30.6% for patients receiving placebo. In cohort 3, the percent reduction in mean EASI score at 28 days was 71.1% for patients receiving soquelitinib and 42.1% for patients receiving placebo.

In cohort 1, 25% of soquelitinib-treated patients achieved IGA 0/1 and 25% achieved EASI 75 after 28 days of treatment. In cohort 2, 17% of soquelitinib-treated patients achieved IGA 0/1 and 33% achieved EASI 75. In cohort 3, 35% of soquelitinib-treated patients achieved IGA 0/1 and 63% achieved EASI 75. No patient receiving placebo achieved IGA 0/1 or EASI 75.

Corvus’ data also revealed relationships between reductions in specific cytokines with improvements in EASI scores. Reductions in serum cytokines were observed in IL-5, IL-9, IL-17, IL-31, IL-33, TSLP, and TARC. According to the announcement, “increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib.”

From the interim phase 1 data, soquelitinib was well-tolerated with no dose-limiting toxicities and no clinically significant laboratory abnormalities in any of the cohorts. Additionally, there were no drug dosing interruptions. Treatment-related and unrelated grade 1/2 adverse events were observed in 32.3% of patients receiving soquelitinib and 25% receiving placebo. One treatment-related adverse event of nausea (grade 1) was reported with soquelitinib treatment.

“We believe the data highlights soquelitinib’s potential as a new treatment option for atopic dermatitis and the broader opportunity for ITK inhibition for other immune related diseases. In addition to blocking the production of multiple inflammatory cytokines, soquelitinib may have persistent direct effects on immune cell function that act to regulate aberrant immune responses. We look forward to completing the Phase 1 trial and initiating other trials with soquelitinib for immune diseases,” Miller said in a 

In-depth discussions of the data will be presented at the Society for Investigative Dermatology 2025 Annual Meeting in San Diego, May 8 from 4:30-6:00 pm PT and May 10 from 9:50-10:00 am PT.

Corvus Pharmaceuticals announces data from cohorts 1-3 of placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. Corvus Pharmaceuticals. News release. May 8, 2025. Accessed May 8, 2025. 

https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-data-cohorts-1-3-placebo

Corvus Pharmaceuticals announces interim data from placebo-controlled phase 1 clinical trial of soquelitinib for atopic dermatitis. Corvus Pharmacetuicals. News release. December 18, 2024. Accessed May 8, 2025. 

https://investor.corvuspharma.com/news-releases/news-release-details/corvus-pharmaceuticals-announces-interim-data-placebo-controlled

Corvus Pharmaceuticals has released interim data from a phase 1 trial of soquelitinib for atopic dermatitis, showing promising safety and efficacy. The trial involved 48 patients across three cohorts, with the highest dose cohort (200 mg twice daily) demonstrating the most significant improvements in EASI and IGA scores. Soquelitinib, an ITK inhibitor, showed potential in modulating immune responses by reducing inflammatory cytokines and increasing T regulatory cells. The trial's success has led to an amendment for extended treatment evaluation, with plans for a phase 2 trial initiation by year-end.

Selective ITK inhibition with oral soquelitinib led to early and durable clinical responses, cytokine reduction, and increased T regulatory cells.

Corvus Pharmaceuticals’ Soquelitinib Shows Rapid, Dose-Dependent Efficacy in Phase 1 AD Trial 

, causes the hardening of skin and connective tissues. Often, the disease harms other organs, such as the heart, kidneys, lungs, and gastrointestinal tract, and it can lead to death.

Within the population of people who have systemic sclerosis, those who have diffuse cutaneous systemic sclerosis often have a worse prognosis and higher mortality rate compared to patients with limited cutaneous systemic sclerosis. Early diagnosis and treatment could slow disease progression, but, currently, there is no clinical biomarker to identify patients at risk for worse outcomes.

, at Yale School of Medicine (YSM) and Francesco Del Galdo, MD, PhD, at Chapel Allerton Hospital in the United Kingdom, showed for the first time that a signature of type 1 interferons (IFNs)—a group of proteins involved in cell signaling—can be used as a blood biomarker for patients with diffuse cutaneous systemic sclerosis.

The findings are an important step toward early identification of this high-risk group of patients.

While scleroderma is rare, affecting around 300,000 people in the United States, it can be very serious.

“It has the highest case fatality rate of all the autoimmune rheumatic diseases—worse than rheumatoid arthritis and lupus,” says Hinchcliff, associate professor of medicine (rheumatology, allergy, and immunology) at YSM.

Doctors usually classify patients with suspected systemic sclerosis based on their disease presentation: Those with skin fibrosis below the elbows and knees are considered to have limited cutaneous scleroderma. These patients usually have less severe outcomes than those with the diffuse subtype, where the skin fibrosis spreads above the knees and elbows, and to other parts of the body.

Some patients with the diffuse subtype can become disabled or can develop progressive and debilitating conditions.

“If we catch patients early and treat them more aggressively, we can often prevent bad outcomes,” says Hinchcliff.

To find a reliable marker that can help doctors predict poor outcomes in diffuse cutaneous scleroderma patients, Hinchcliff and clinician scientists from 11 academic centers in the United States partnered to recruit patients with early diffuse cutaneous systemic sclerosis. In 2012, the scientists teamed up to create the U.S. Prospective Registry of Early Systemic Sclerosis (PRESS). The registry consists of patients with early diffuse cutaneous systemic sclerosis who fulfill specific criteria. The new study included 110 PRESS patients.

Around the same time, a group of scientists in the U.K. led by Del Galdo began recruiting another cohort of 32 healthy individuals and 72 patients diagnosed with diffuse cutaneous systemic sclerosis. This cohort was called the Stratification for Risk of Progression in Scleroderma (STRIKE).

High levels of type 1 IFNs are linked to worse outcomes in individuals with autoimmune diseases such as rheumatoid arthritis and lupus. But blood serum levels of type 1 IFNs are difficult to measure. To overcome that challenge, the scientists measured the concentrations of several molecules that appear in response to type 1 IFNs and are abundant enough to measure, thus serving as an indirect measure of type 1 IFNs.

They found that individuals in the PRESS cohort who had high IFN serum scores tended to have worse lung function and disability, such as chronic joint pain, at the beginning of the study and worse lung function during follow-up compared to patients with low IFN serum scores. In the STRIKE cohort, patients with high IFN serum scores had worse lung function than those with low scores, and the differences persisted during follow-up. Across both cohorts, those with high IFN scores also had higher mortality rates than those with lower scores.

Given that scleroderma-related lung disease is the leading cause of death in the scleroderma patient population, the identification of a blood biomarker that may be able to identify patients at heightened risk for lung disease is an important finding.

Hinchcliff believes that the high serum IFN score may one day be useful in predicting which patients in the early stages of their disease are at risk for ultimately developing severe disease, allowing for more personalized and effective treatments.

“These are people at high risk, and we really need to be focused on monitoring them closely and treating them aggressively before lung damage occurs,” Hinchcliff says.

“Our results suggest that measuring type I IFN activity is akin to assessing the fuel driving autoimmune processes in systemic sclerosis patients,” she adds. While additional validation and testing are necessary, “the ability to possibly discriminate between high-risk and low-risk patients with diffuse cutaneous systemic sclerosis using a blood test represents a large step forward for the community.”

 was supported by the National Institute of Arthritis Musculoskeletal and Skin Diseases (awards P30AR061271, R01AR073270,

Systemic sclerosis, particularly the diffuse cutaneous subtype, poses significant health risks, including organ damage and high mortality. Recent research has identified type 1 interferons (IFNs) as a potential blood biomarker for early detection of high-risk patients. This discovery could enable more personalized treatment strategies, potentially improving outcomes by identifying patients at risk for severe disease progression, especially lung-related complications. The study, supported by various health institutes, highlights the importance of early diagnosis and aggressive treatment to mitigate the disease's impact.

Researchers identify a blood biomarker linked to worse outcomes in diffuse cutaneous systemic sclerosis, paving the way for early detection and treatment.

Neha Kinariwalla

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