UNION Therapeutics Presents Positive Results for Orismilast
UNION Therapeutics Presents Groundbreaking Results for Orismilast
Today, UNION therapeutics A/S, a leading clinical-stage pharmaceutical company focused on immunology, shared exciting results from their ADESOS Phase 2b study, which evaluated the effectiveness of orismilast for treating atopic dermatitis (AD). Presented by Prof. Dr. Eric Simpson, these results were unveiled during the European Academy of Dermatology and Venerology (EADV) Congress 2024, demonstrating the potential of orismilast as a first-in-class oral therapy.
Study Overview and Significant Findings
This study involved 233 patients with moderate to severe AD, divided across several groups receiving different dosages of orismilast—20mg, 30mg, and 40mg—compared against a placebo. Remarkably, results indicated that a significantly higher percentage of patients on orismilast achieved the Investigator Global Assessment (IGA) scores of 0/1 at the 16-week mark, highlighting the treatment's efficacy: 26.3% in the 20mg group, 24.3% for the 30mg group, and 30.9% in the 40mg group versus 9.5% for placebo, all providing statistically significant outcomes (p <0.05).
Rapid Reduction of Itch and Skin Biomarkers
Leading the charge of impressive findings, orismilast showed a notable fast onset in itch reduction; all dosage arms saw significant improvements at the two-week mark. This was measured through the Numerical Rating Scale (NRS), confirming the importance of quick relief for patients suffering from itch, a common and distressing symptom of AD. Skin biomarkers exhibited a similar positive trend, with TARC levels significantly improved across all active treatments in comparison with placebo.
Safety and Tolerability of Orismilast
In alignment with previous studies, the safety profile of orismilast remained consistent, showing no new safety signals. Common Treatment-Emergent Adverse Events (TEAEs) reported included diarrhea, nausea, and headache, primarily observed within the initial month, with most cases being mild. This reassuring data provides further credence to the tolerability of orismilast as an oral treatment option.
Future Plans for Orismilast Development
Following an optimistic End-of-Phase 2 meeting with regulatory bodies, UNION therapeutics is gearing up to advance orismilast into Phase 3 clinical trials, specifically targeting its application in atopic dermatitis. Kim Kjøller, Co-CEO of UNION, expressed enthusiasm about the results presented and highlighted the focus on developing safe and effective treatment options for patients suffering from AD.
Orismilast: A Promising New Treatment
Orismilast, a potent PDE4 inhibitor, has previously demonstrated efficacy not only in AD but also in conditions like psoriasis and hidradenitis suppurativa. This dual-action treatment targets specific pathways linked to inflammation, set apart from previously marketed PDE4 inhibitors, thus holding great potential in addressing various immunological diseases.
Impacts of Atopic Dermatitis
Atopic dermatitis is a chronic skin condition affecting a significant proportion of the population, attributed to substantial psychosocial challenges including anxiety, depression, and disruption to sleep among patients. The introduction of orismilast as an efficacious oral treatment could play a pivotal role in enhancing the quality of life for those afflicted with AD.
Frequently Asked Questions
What is the ADESOS Phase 2b study about?
The ADESOS Phase 2b study aimed to evaluate the efficacy and safety of orismilast in patients with moderate to severe atopic dermatitis.
What were the main findings from the study?
The study found significant efficacy in reducing symptoms of atopic dermatitis in patients treated with orismilast, demonstrating notable overall improvement compared to a placebo.
Who presented the results at the EADV Congress 2024?
The results were presented by Prof. Dr. Eric Simpson, showcasing the potential of orismilast as a treatment option in dermatology.
What are the next steps for orismilast development?
UNION therapeutics plans to proceed with Phase 3 development of orismilast for treating atopic dermatitis following positive meetings with regulatory authorities.
How does orismilast compare to existing treatments?
Orismilast is distinguished for its high potency and selectivity, potentially offering a safer oral treatment option compared to existing PDE4 inhibitors, making it an exciting new choice for patients and healthcare providers.
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