Dermavant Announces First Patient Dosed in Phase 2a Clinical Trial

Dermavant Sciences recently announced that the first patient has been dosed in its Phase 2a vitiligo clinical trial for topical cerdulatinib. Cerdulatinib is a dual inhibitor of the Janus kinase (JAK) and spleen tyrosine kinase (Syk) pathways, which Dermavant is evaluating as a differentiated topical treatment option for vitiligo and other inflammatory skin conditions such as atopic dermatitis.

“With vitiligo affecting an estimated 65-95 million people worldwide, including approximately 2.4 million people in the US, I am excited to announce that the first vitiligo patient has been dosed with topical cerdulatinib in this Phase 2a clinical trial,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Physicians and patients want transformative approaches in dermatology. Based on preclinical data observed to date, we believe cerdulatinib has the potential to be an important treatment option for vitiligo, a chronic skin disease which has no FDA-approved treatment currently available.”

“Vitiligo can be an incredibly stigmatizing, devastating disease for my patients,” said John Harris, MD, PhD, Director of the Vitiligo Clinic and Research Center at the University of Massachusetts Medical School. “I am grateful to see a medical dermatology company like Dermavant focus its research and development efforts on therapies to address this debilitating condition and offer patients hope for better treatments.”

The Phase 2a study is a multi-center, randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, and systemic exposure of cerdulatinib gel 0.37%, dosed twice daily for six weeks versus vehicle in 30 adult patients aged 18-70 years diagnosed with vitiligo.

The primary endpoints of the study will be the safety and tolerability of topical administration of cerdulatinib gel 0.37% in adult subjects with vitiligo assessed by: frequency, duration, and severity of adverse events (local and systemic); vital signs; laboratory values; and local tolerability scale (LTS) scores.

Vitiligo is a chronic skin disease characterized by smooth, white patches of skin due to the loss of natural skin color. Vitiligo can also affect other parts of the body, including hair, eyes, and the inside of the mouth. It is caused by immune system damage of the cells that provide color to the skin and hair, called melanocytes. Vitiligo can severely impact quality of life and psychological wellbeing due to its appearance and visibility. The psychological impact of vitiligo commonly manifests as depression, anxiety, and low self-esteem and may be associated with social isolation.

Vitiligo is the most common skin depigmentation disorder, with the average prevalence estimated to be between 0.5% to 2% of the global population. An estimated 65-95 million people of all ages, sexes, and ethnicities worldwide suffer from vitiligo, including approximately 2.4 million people in the U.S. The majority (70–80%) of patients with vitiligo experience disease onset before age 30. Approximately 30% have childhood-onset vitiligo before age 12. Most patients have vitiligo for the rest of their lives, during which they will experience cycles of flare-ups, stabilization, and spontaneous re-coloration of affected areas. There are no FDA-approved treatments for vitiligo. Dermatologists typically prescribe topical corticosteroids, topical calcineurin inhibitors and/or phototherapy.

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology. Dermavant leverages the Roivant platform to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The Company’s robust medical dermatology pipeline includes both late-stage and early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, psoriasis and atopic dermatitis, as well as other large markets, including vitiligo, primary focal hyperhidrosis, and acne. Dermavant is developing its lead product candidate, tapinarof (DMVT-505), as a differentiated therapeutic aryl hydrocarbon receptor modulating agent (TAMA) topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 7.5 million and 28 million people in the United States, respectively. For more information, visit www.dermavant.com.

Roivant Sciences aims to improve health by rapidly delivering innovative medicines and technologies to patients. It does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, visit www.roivant.com.