GlaxoSmithKline (GSK) said today that it has sold mostly-global rights to its Phase III-bound psoriasis and atopic dermatitis candidate tapinarof (GSK2894512) to Dermavant Sciences for up to £250 million ($330 million).
Dermavant, a Roivant Sciences company focused on dermatology treatments, bought rights to tapinarof that cover all countries except China. However, Dermavant bought global rights to a preclinical topical backup program to tapinarof, and has agreed to be responsible for all development milestones owed to third parties, GSK said.
GSK, Roivant, and Dermavant also agreed to enter into agreements covering tapinarof’s Phase III program and commercial supply.
Tapinarof is a therapeutic aryl hydrocarbon receptor modulating agent (TAMA) that according to a 2017 study binds and activates the aryl hydrocarbon receptor in multiple cell types, including cells of the target tissue-human skin. That study also showed tapinarof to moderate proinflammatory cytokine expression in stimulated peripheral blood CD4+ T cells and ex vivo human skin, and impact barrier gene expression in primary human keratinocytes.
Tapinarof met its primary endpoint in a global Phase IIb placebo-controlled dose-ranging study that enrolled 227 adults with plaque psoriasis (NCT02564042) by showing clinically meaningful, dose-dependent improvements over vehicle in the proportion of treated patients who achieved Physician Global Assessment (PGA) scores of clear or almost clear (0 or 1) following 12 weeks of treatment, with a minimum of 2-grade improvement in 5-point PGA score from baseline.
According to GSK, 56% of patients in the tapinarof 1% once-daily group, and 46% of patients in the tapinarof 0.5% once-daily group, achieved 75% or greater improvement in Psoriasis Area and Severity Index scores (PASI 75) after 12 weeks of treatment, compared to 5% in the placebo once-daily group.
In a separate double-blind, placebo-controlled global Phase IIb dose-ranging study that enrolled 247 patients with atopic dermatitis (NCT02564055), tapinarof demonstrated clinically meaningful, dose-dependent improvements over vehicle on the primary endpoint of the study, the proportion of patients with Investigator Global Assessment (IGA) scores of clear or almost clear (0 or 1) after 12 weeks of treatment with a minimum of 2-grade improvement in 5-point IGA score from baseline.
Tapinarof has been assessed as a topical therapy in Phase I and Phase II studies involving over 800 participants.
“This will be the cornerstone of Dermavant’s pipeline, and we are grateful for the opportunity to advance its development,” Dermavant Executive Chair Jackie Fouse, Ph.D., said in a statement.
Dermavant agreed to pay GSK £150 million ($198 million) upfront and up to £100 million ($132 million) in payments tied to achieving milestones. The deal is expected to be completed later this year, subject to antitrust clearance and other regulatory approvals.
For GSK, the sell-off of tapinarof continues the pharma giant’s overhaul of its R&D effort under CEO Emma Walmsley, who succeeded Sir Andrew Witty as of March 31, 2017.
GSK has overhauled its R&D pipeline, last year terminating more than 30 clinical and preclinical programs deemed by the company as “unlikely to generate sufficient returns.” GSK also named a new CSO and president, R&D, Hal Barron, M.D., who previously served as president of R&D at Calico (California Life Sciences LLC), a Google-backed company launched in 2013.
“We have taken a strategic decision to divest or partner medicines in our R&D portfolio that are a better fit for other companies allowing us to concentrate our resources on other promising assets,” states John Lepore, M.D., senior vp, R&D pipeline, GSK.
“Tapinarof has the potential to be a first-in-class therapy and a convenient, once-daily topical agent that postpones or potentially eliminates the need for systemic treatment in two of the most common dermatological conditions, psoriasis and atopic dermatitis,” Dr. Lepore adds. “We are confident that Dermavant is well positioned to progress rapidly with the tapinarof development program into Phase III and registration.”
As a result of the GSK deal, tapinarof is one of 31 investigational drugs in 11 therapeutic areas being tested in more than 50 clinical trials by Dermavant and the rest of Roivant’s family of companies.
That family includes Myovant (women’s health), Axovant (neurology), Urovant (urology), Enzyvant (rare diseases), Genevant (RNA therapeutics), Metavant (cardiometabolic diseases), Immunovant (immunology), Altavant (next-generation drug development), Datavant (healthcare data), and Arbutus (hepatitis B).