Hyperkeratosis

LEO Pharma Announces Positive Phase 3 Topline Results From DELTA 1 Trial With Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (CHE)

Retrieved on: 
Tuesday, December 6, 2022

LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 1 trial.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 1 trial.
  • DELTA 1 is the first of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).
  • In addition to the DELTA 1 trial, delgocitinib cream is also being investigated in the second pivotal trial DELTA 2, which is still ongoing.
  • LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults.

Timber Pharmaceuticals Announces Positive End-of-Phase 2 Meeting with FDA for TMB-001 in Moderate to Severe Congenital Ichthyosis

Retrieved on: 
Thursday, February 3, 2022

BASKING RIDGE, NJ, Feb. 03, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) that resulted in a clear path to progress to a pivotal Phase 3 study for its lead asset, TMB-001, a topical isotretinoin formulated using the company’s patented IPEG™ delivery system.

Key Points: 
  • Timber completed the Phase 2b CONTROL study evaluating TMB-001 in moderate to severe congenital ichthyosis (CI) in September 2021 and announced that topline data demonstrated clinically meaningful efficacy with a favorable safety profile.
  • Based on FDA feedback at the End-of-Phase 2 meeting, Timber intends to initiate a pivotal Phase 3 study of TMB-001 in the second quarter of 2022.
  • Patients with moderate to severe subtypes of CI, including X-linked ichthyosis (XLRI) and autosomal recessive congenital ichthyosis (ARCI), which includes lamellar ichthyosis (LI), often have considerable hyperkeratosis and skin scaling.
  • Treatment of moderate to severe CI represents a clear unmet need in dermatology as there are currently no approved FDA treatments for these conditions.