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

Arcutis Enjoys Seborrheic Dermatitis Win But Experts Itching For Psoriasis Approval

 
• By Ayisha Sharma

The firm is planning a US NDA filing after its roflumilast formulation succeeded in a pivotal seborrheic dermatitis study but analysts are keener on a ‘make or break’ approval in psoriasis.  

Roflumilast Has An Oral, Cream And Foam Formulation • Source: Shutterstock

Arcutis Biotherapeutics, Inc.’ roflumilast foam product has passed an advanced seborrheic dermatitis study prompting filing plans but experts are more invested in a potentially “transformational” psoriasis approval expected in July.

The Westlake Village, CA-headquartered biotech unveiled topline data from the Phase III STRATUM study of 457 seborrheic dermatitis patients on 6 June. Roflumilast foam 0.3% met the primary endpoint with 80.1% of treated participants achieving investigator’s global assessment scale (IGA) success at eight weeks versus 59.2% of vehicle control patients (p<0

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

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor Into For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

More from R&D

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.