A potential best-in-class treatment for immunological skin diseases

Orismilast MR (modified release) is a next-generation phosphodiesterase type-4 (“PDE4”) inhibitor with high potency for the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade to induce a broad range of anti-inflammatory effects. 

Orismilast has been selected as lead molecule based on its attractive therapeutic window (i.e., the combination of improved efficacy and tolerability) and because of its potential to inhibit many inflammatory pathways involved in immunologic diseases due to the broad range of anti-inflammatory effects.

Over the course of Phase 1 and Phase 2 trials, orismilast has been demonstrated to be safe in both oral and topical dosage forms and the PDE4 mode-of-action has been verified as an effective, well-tolerated approach to treatment of patients across multiple diseases, with no need for monitoring.

UNION is developing orismilast MR as an oral formulation.

Mild-to-Moderate

+ 0 M

13,4M suffers from Psoriasis in the US, EU5 and Japan

PDE4 inhibitor

Dermatology market and include
topical roflumilast cream

PDE4 Market and include
topical roflumilast cream

Moderate-to-servere

= 0 M

People in the US suffer from Psoriasis

TNF-Q + 11-17

Plaque psoriasis and atopic
dermatitis

Acim quam ratem eos dis ma
doluptatist

Checkpoint-for Psoriasis

= 0 M

People in EU5 suffer from Psoriasis

Keratinoc

Exerting anti-inflammatory effect
reducing psoriasis scale formation

PDE4 Market and include
topical roflumilast cream

Orismilast development programs

The current development status of orismilast MR is the following:

  • Psoriasis: UNION has initiated IASOS, a Phase 2b study with orismilast MR tablet in psoriasis patients. In November 2020, the US Food and Drug Administration (FDA) approved UNION’s Investigational New Drug Program (IND) for advancing orismilast MR into a Phase 2b trial in patients with moderate to severe psoriasis. ClinicalTrials.gov Identifier: NCT05190419
  • AD: The FDA has granted Fast Track designation to orismilast MR for the treatment of moderate to severe AD, and UNION initiated a Phase 2b dose finding study in July 2022. The ClinicalTrials.gov Identifier is NCT05469464
  • HS: In the Fall of 2021, OSIRIS, an investigator sponsored Phase 2a, open label, proof-of-concept study in patients with mild to severe hidradenitis suppurativa (HS) was initiated with support from UNION. ClinicalTrials.gov Identifier: NCT04982432 
 

UNION has also tested orismilast as a topical formulation in a Phase 2a study. In the Phase 2a proof-of-concept study in AD topical orismilast demonstrated statistically significant efficacy compared to placebo with no stinging, burning or pain at the application site.