1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Arcutis’s Phase III AD Win Bodes Well For Soon-To-Report Second Study

 
• By Alaric DeArment

One analyst said efficacy data for roflumilast in INTEGUMENT-1 suggest limited competitiveness against Incyte’s topical JAK inhibitor, Opzelura, while others were more optimistic.

Arcutis announced Phase III results for roflumilast in atopic dermatitis • Source: Shutterstock

Arcutis Biotherapeutics, Inc.’s Phase III study for roflumilast cream in mild-to-moderate atopic dermatitis (AD) hit its primary endpoint, raising hopes of a second Phase III win before the year is up and, with that, boosting chances for US Food and Drug Administration approval. But how roflumilast will fare in a crowded market for topical AD treatments – especially against existing players like Incyte Corporation’s Opzelura (ruxolitinib) and Pfizer Inc.’s Eucrisa (crisaborole) – remains to be seen.

Arcutis announced positive topline results from the pivotal INTEGUMENT-1 trial of roflumilast cream 0.15% on 15 November. The drug is...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Argenx Powers Ahead With Vyvgart’s Prefilled Syringe Launch

 
• By Andrew McConaghie

The Netherlands-headquartered company is enjoying huge success with Vyvgart in two autoimmune conditions, with a new prefilled syringe version reaching more patient groups.

Sanofi CFO Says Direct Sales To Patients ‘Certainly Worth Considering’

 
• By Kevin Grogan

François Roger believes fixing inefficiencies is more important than playing with pricing.

Vyne Seeks Partner For Repibresib After Phase IIb Vitiligo Fail

 
• By Alaric DeArment

The Phase IIb study failed its primary and a key secondary endpoint, but showed activity on another key secondary and an exploratory endpoint.

Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 
• By Andrew McConaghie

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

More from R&D

Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 
• By Andrew McConaghie

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

PTC To Challenge BioMarin In PKU With Oral Sephience

 
• By Joseph Haas

PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.

Lilly’s Jaypirca Threatens Imbruvica’s CLL Position After Phase III Results

 
• By Alaric DeArment

The BRUIN CLL-314 trial was designed to show noninferiority, but the p-value indicated a favorable result for Jaypirca in both the pre-treated and intent-to-treat populations.