Dermavant Sciences is set to recruit 30 patients in its Phase IIa proof-of-concept trial investigating DMVT-502 (cerdulatinib) in vitiligo, with the first patient expected to be dosed this month, CEO Todd Zavodnick said.

The primary efficacy endpoint will use a blister model approach, where topical cerdulatinib will be tested to determine whether it can reduce relevant disease mediators, Zavodnick added. Vitiligo is a long-term condition where pale white patches develop on the skin.

The Phase IIa trial is not yet listed on Previously, Dermavant only announced the Phase IIa trial to start in 2019, with top-line results expected in the second half of 2020, according to a May 2019 Securities and Exchange Commission (SEC) filing.

Based in both Basel, Switzerland and Phoenix, Arizona, Dermavant has signalled its intention to go public and is preparing a US$100m initial public offering, according to a 10 June SEC filing.

Dermavant has given itself 12 months to run the Phase IIa trial, with the target to recruit at least one patient every two months, Zavodnick said. This recruitment pace is set by the overall challenge in enrolling vitiligo patients, he added. It would be possible to speed up enrolment by engaging with patient support groups, or having speciality vitiligo sites at the University of Massachusetts and Harvard University in the Phase IIa trial, he said. Zavodnick declined to name the trial CRO.

The Phase IIa trial will collect liquid from blisters to investigate whether cerdulatinib can reduce Chemokine (C-X-C motif) ligand 9 (CXCL9) and CXCL10, which are upregulated during pigmentation abnormality in vitiligo patients, Zavodnick added.

Cerdulatinib is a dual inhibitor of Janus kinase (JAK) and spleen tyrosine kinase (SYK), where inhibiting the former impacts inflammation and the latter is relevant to where inflammation starts in the Langerhans cells, he explained.

Tapinarof nonsteroidal approach and price an edge

On 14 August, this news service reported Dermavant’s lead asset tapinarof, which is indicated for mild-to-moderate plaque psoriasis, drew expert enthusiasm for Phase III success; however, there could be an efficacy obstacle because the trial enrols patients with a psoriasis body surface area (BSA) of ≤20%, which is too large an area for a topical approach.

While Zavodnick acknowledged dermatologists would typically switch to an oral or injectable administration in patients with a BSA of 10%, these clinicians have never had a nonsteroidal approach in psoriasis, which means tapinarof could be an exception. Tapinarof could be used as an alternative to topical corticosteroids, which need breaks to maintain their efficacy and reduce adverse event risks, this news service previously reported. Long-term continuous use of corticosteroids could also cause adrenal gland suppression and the risk of Cushing’s syndrome.

Tapinarof will not have an extravagant price, and could be priced in the same range as Bausch Health’s topical Duobrii (halobetasol propionate and tazarotene), Zavodnick added. Duobrii, which was approved by the US Food and Drug Administration (FDA) on 25 April for psoriasis, costs US$871 for a 100g supply, public information shows.

The 500-patient, vehicle-controlled Phase III trials PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980) investigating tapinarof are identical, with a primary endpoint of proportion of patients achieving a Physician Global Assessment (PGA) score of clear (0) or almost clear (1), with a minimum 2-grade improvement from baseline at week 12. The aryl hydrocarbon receptor modulating agent has top-line data expected 1H20, as per a 5 June media release.

by Reynald Castaneda in London
Reynald Castaneda is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.