HELLERUP, Denmark, Aug. 4, 2022 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, announces that the first patient has been enrolled in ADESOS, a Phase 2b dose-finding study evaluating the safety and efficacy of orismilast MR tablet in adult patients with moderate to severe AD. The purpose of the study is to identify the appropriate dose regimen for Phase 3 studies.
In November 2021, the US Food and Drug Administration (FDA) granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD. The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. This underscores the need for new treatment options with potential to fulfil the unmet medical needs for people affected by AD.
UNION has recently investigated the inhibitory effect of orismilast on the secretion of various inflammatory cytokines in human peripheral blood mononuclear cells in vitro. Orismilast underlined its potential in AD, psoriasis, and HS by demonstrating broad anti-inflammatory properties with potent inhibition of the main cytokines involved in these indications1). Data from the study will be presented at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-11 September 2022.
Kim Kjller, Chief Executive Officer of UNION therapeutics said:"Orismilast modified release tablet holds the potential to become a first-in-class treatment and become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis. The initiation of the ADESOS study marks an important advancement of UNION's pipeline."
Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS adds: "AD is one of the most common chronic skin diseases worldwide. Despite recent advancements in the treatment of AD, there are still many unmet needs for safe and effective oral treatments. Orismilast modified release tablet has the potential to be an effective and patient-friendly treatment option in AD."
About the ADESOS Phase 2b studyThe Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of orismilast MR tablet in patients with moderate to severe AD. The study will target 210 patients who will be randomized to three active doses (20mg, 30mg, and 40 mg) of orismilast relative to placebo administered twice daily. The study will be conducted in centers in Europe and the US.
About orismilastUNION is developing orismilast, which is a potent next-generation phosphodiesterase type-4 (PDE4) inhibitor operating early in the inflammation cascade to induce a broad spectrum of downstream anti-inflammatory effects. Orismilast has the potential to inhibit many inflammatory pathways involved in dermatological and immunological diseases and holds potential to become a safe and efficacious treatment option in various dermatological and immunological diseases.
UNION has two product candidates with orismilast in its clinical stage pipeline: Orismilast MR tablet currently investigated for the treatment of psoriasis, AD and HS; and topical orismilast with clinical proof of concept established in AD. UNION is progressing orismilast as a modified release tablet to minimize the occurrence of gastrointestinal side effects typically associated with PDE4-inhibition.
In November 2020, the FDA cleared UNION's Investigational New Drug (IND) application for orismilast MR tablet, and in November 2021, the FDA granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD.
In September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologic for orismilast in Mainland China, Hong Kong, Macau and Taiwan2).
About atopic dermatitisAD is a chronic inflammatory skin disease affecting approximately 3% of the adult population worldwide and is the most common skin disease among children, with the disease commonly occurring by five years of age3). There was approximately 26 million diagnosed cases of AD in 2021 in the Seven Major Markets (US, France, Germany, Italy, Spain, UK, and Japan)4). Disease symptoms are characterized by recurrent eczematous skin lesions and intense itch. AD has a substantial psychosocial impact on patients and relatives5). During disease flares, approximately 80% of patients may experience disturbed sleep, which may also disrupt the sleep of family members6). The disease also appears to impact the mood and patients have an increased risk of anxiety and depression7).
Sources
1. In vitro study to assess the effect of orismilast on cytokine production in human PBMCs. Study number: DSK0001
3. https://pubmed.ncbi.nlm.nih.gov/25925336/
4. Decision Resources Group (2020): Atopic Dermatitis Disease Landscape & Forecast. Published November 12, 2020
5. https://pubmed.ncbi.nlm.nih.gov/33006135/
6. https://pubmed.ncbi.nlm.nih.gov/24290431/
7. https://pubmed.ncbi.nlm.nih.gov/27616422/
ContactsMorten Boesen, Chief Financial Officer, UNION therapeutics A/S+45 2381 5487morten.boesen@uniontherapeutics.com
Sarah Toft-Jrgensen, Director of Communications and IR, UNION therapeutics A/S+45 5385 3044stj@uniontherapeutics.com
About UNION therapeuticsUNION therapeutics is a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with multiple candidates in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and seasoned pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at http://www.uniontherapeutics.com
This information was brought to you by Cision http://news.cision.com
SOURCE UNION therapeutics
Go here to see the original:
UNION therapeutics announces enrollment of the first patient in ADESOS Phase 2b study of orismilast MR tablet in patients with atopic dermatitis -...
- Guselkumab Demonstrates Significant Improvement in Psoriasis Symptoms and HRQoL, Reduces Sexual Impairment ... - Dermatology Times - April 18th, 2024 [April 18th, 2024]
- Psoriasis Patients with Arthralgia At Increased Risk of Psoriatic Arthritis Development - MD Magazine - April 18th, 2024 [April 18th, 2024]
- Diagnosing Psoriatic Arthritis for the Dermatologist: Guidance From the Experts - Medscape - April 18th, 2024 [April 18th, 2024]
- Secukinumab 300 mg May Improve PsA or Active Psoriasis More Than 150 mg - MD Magazine - April 18th, 2024 [April 18th, 2024]
- The Impact of Pediatric Plaque Psoriasis on Children and Caregivers - HMP Global Learning Network - April 18th, 2024 [April 18th, 2024]
- Guselkumab Led to Improvements Over Several Psoriatic Arthritis Disease Domains - MD Magazine - April 18th, 2024 [April 18th, 2024]
- Dual Diagnosing and Managing Psoriasis and Psoriatic Arthritis - The Dermatologist - April 18th, 2024 [April 18th, 2024]
- Etanercept Effective for Psoriasis, Rheumatic Disease Among Patients Extending Treatment After 12-Weeks - MD Magazine - February 9th, 2024 [February 9th, 2024]
- High Response Rates in Psoriasis With Oral IL-23 Inhibitor - Medpage Today - February 9th, 2024 [February 9th, 2024]
- Psoriasis and eczema have complex causes and consequences that researchers are seeking to uncover - Medical Xpress - February 9th, 2024 [February 9th, 2024]
- New Hope in Treatment of Plaque Psoriasis: Study Shows Promising Results - Medriva - February 9th, 2024 [February 9th, 2024]
- No Difference in Psoriasis Immune Response Despite Switch Between AVT02, Adalimumab - MD Magazine - February 9th, 2024 [February 9th, 2024]
- Oral IL-23 Receptor Antagonist Peptide Effective in PASI Reduction for Psoriasis - MD Magazine - February 9th, 2024 [February 9th, 2024]
- Breakthrough in Psoriasis Treatment: JNJ-77242113 Shows Promising Results - Medriva - February 9th, 2024 [February 9th, 2024]
- Promising Results from Phase II Trial of Oral Interleukin Inhibitor for Psoriasis Treatment - Medriva - February 9th, 2024 [February 9th, 2024]
- Promising Results from the FRONTIER 1 Trial - An Exploration of JNJ-77242113 in the Treatment of Moderate-to ... - Medriva - February 9th, 2024 [February 9th, 2024]
- Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva - February 9th, 2024 [February 9th, 2024]
- Rising Cost of Stelara: Impact on Patients and Johnson & Johnson's Market Performance - Medriva - February 9th, 2024 [February 9th, 2024]
- Global Psoriatic Arthritis (PsA) Treatment Market to achieve a remarkable US$ 15.6 Billion by 2028, - PharmiWeb.com - February 9th, 2024 [February 9th, 2024]
- Tremfya potential highlighted by industry analyst GlobalData - The Pharma Letter - May 31st, 2023 [May 31st, 2023]
- Stress Leads to Increased Risk of Depression, Anxiety for Psoriasis ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- Janssen Announces Positive Results From Guselkumab Psoriatic ... - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- Early Intervention with Secukinumab May Be Effective for Patients ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- VEGF-A Inhibition Downregulates Blood Vessel Area in Psoriasis - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- Scratching the itch, Lynk Pharmaceuticals trialling ointment for ... - OutSourcing-Pharma.com - May 31st, 2023 [May 31st, 2023]
- Brepocitinib More Efficacious Than Placebo in Long-Term Psoriatic ... - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- For Patients With Birthmarks, Psychosocial Interventions Improved ... - Dermatology Times - May 31st, 2023 [May 31st, 2023]
- Robert Hariri, MD: Natural Killer Cell Therapy Shows Remarkable ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- Nalbuphine ER Tablets Show Promise as Cough Therapy in ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- Benefit of Empagliflozin in HFpEF Consistent Regardless of Diuretic ... - MD Magazine - May 31st, 2023 [May 31st, 2023]
- selectION reports results from SAD stage of si-544 Phase Ib trial - Clinical Trials Arena - May 31st, 2023 [May 31st, 2023]
- No Link Observed Between Gastrointestinal Tract Surgery and New ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- Lynk doses first cohort in Phase Ib trial of psoriasis therapy - Clinical Trials Arena - May 30th, 2023 [May 30th, 2023]
- Metabolic Inflammation Contributes to Depression in Psoriatic Disease - Dermatology Times - May 30th, 2023 [May 30th, 2023]
- Encouraging Diversity and Inclusion for Patients With Psoriatic ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- The Weekly Roundup: May 22-26 - Dermatology Times - May 30th, 2023 [May 30th, 2023]
- Pediatric Psoriasis Market: A Study of the Industry's Key Applications ... - The Navajo Post - May 30th, 2023 [May 30th, 2023]
- Phototherapy Lamps Market are set to witness a CAGR of 5.8 ... - Digital Journal - May 30th, 2023 [May 30th, 2023]
- Celltrion seeks approval for Stelara biosimilar in EU - The Investor - May 30th, 2023 [May 30th, 2023]
- Peter Marinkovich, MD: FDA Approval of B-VEC Gene Therapy for ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- Nick Stucky, MD, Phd: Implications for Media Influence on Minoxidil ... - MD Magazine - May 30th, 2023 [May 30th, 2023]
- Tildrakizumab Linked With HRQOL Improvement in Psoriasis in a Real-World Setting - AJMC.com Managed Markets Network - May 18th, 2023 [May 18th, 2023]
- Clinical Utility of Deucravacitinib for the Management of Moderate to ... - Dove Medical Press - May 18th, 2023 [May 18th, 2023]
- Covid-19 and Psoriasis: Is there a link? - Dunya News - May 18th, 2023 [May 18th, 2023]
- Improvement Needed in Study Interventions to Better Skin Self ... - AJMC.com Managed Markets Network - May 18th, 2023 [May 18th, 2023]
- Reviva Pharmaceuticals Announces Intent to File an IND for Brilaroxazine in Psoriasis After Promising Preclinical Data - Marketscreener.com - May 18th, 2023 [May 18th, 2023]
- Adam Friedman, MD: Addressing Disparities in Care for Patients ... - MD Magazine - May 18th, 2023 [May 18th, 2023]
- Early-Infancy Meningitis Infection Linked With Increased Risk of ... - AJMC.com Managed Markets Network - May 18th, 2023 [May 18th, 2023]
- NOVN: Counting Down to PDUFA - Yahoo Finance - May 18th, 2023 [May 18th, 2023]
- Psoriatic Arthritis (PsA) Treatment Market is likely to register CAGR ... - Future Market Insights - May 18th, 2023 [May 18th, 2023]
- New campaign raises awareness of topical steroid withdrawal - Professional Beauty - May 18th, 2023 [May 18th, 2023]
- MoonLake Immunotherapeutics completes patient enrollment and randomization ahead of schedule in a Phase 2 trial of the Nanobody sonelokimab in... - February 2nd, 2023 [February 2nd, 2023]
- EVELO BIOSCIENCES, INC. : Costs Associated with Exit or Disposal Activities, Change in Directors or Principal Officers, Other Events (form 8-K) -... - February 2nd, 2023 [February 2nd, 2023]
- 12 Ways to Treat Psoriasis at Home - Healthline - January 22nd, 2023 [January 22nd, 2023]
- DTC Advertising Of Prescription Drugs In The U.S. Often Promotes Products With Comparatively Low Therapeutic Value - Forbes - January 19th, 2023 [January 19th, 2023]
- Types of Psoriasis: Pictures, Symptoms and Treatments - Healthline - December 18th, 2022 [December 18th, 2022]
- Psoriasis Pathogenesis and Treatment - PMC - PubMed Central (PMC) - November 23rd, 2022 [November 23rd, 2022]
- Drug-Provoked Psoriasis: Is It Drug Induced or Drug Aggravated? - November 23rd, 2022 [November 23rd, 2022]
- Im a Dermatologist and These 7 Things Could Be Making Your Psoriasis Worse - Well+Good - October 19th, 2022 [October 19th, 2022]
- 'Worst time of the year for me to be covered in scabs': Amber Heard's Alleged Ex Cara Delevingne Revealed Her Psoriasis Struggle Made Kate Moss Scream... - October 19th, 2022 [October 19th, 2022]
- Psoriasis: What It Is, Symptoms, Causes, Types & Treatment - October 17th, 2022 [October 17th, 2022]
- What is psoriasis and which foods ease symptoms? - Evening Standard - October 17th, 2022 [October 17th, 2022]
- Chronic inflammatory diseases: what they are - Emergency Live International - October 17th, 2022 [October 17th, 2022]
- How remote care can deliver a step change in treatment for inflammatory skin conditions - PoliticsHome - October 17th, 2022 [October 17th, 2022]
- Probiotics Supplementation may Improve Symptoms of Hyperuricemia and Gout - Rheumatology Network - October 15th, 2022 [October 15th, 2022]
- Psoriasis Pathogenesis and Treatment - PubMed - October 2nd, 2022 [October 2nd, 2022]
- Best and Worst Drinks for Psoriasis - Everyday Health - October 2nd, 2022 [October 2nd, 2022]
- These Are the 10 Most Common Chronic Skin Conditionsand the Most Important Facts to Know About Them - Parade Magazine - October 2nd, 2022 [October 2nd, 2022]
- Survey Addresses Concerns Regarding Reproductive Healthcare Communication in Women with RA, PsA - Rheumatology Network - October 2nd, 2022 [October 2nd, 2022]
- Psoriasis Types, Symptoms & Causes | NIAMS - September 29th, 2022 [September 29th, 2022]
- What Is Psoriasis And Can It Be Treated? - Forbes - September 29th, 2022 [September 29th, 2022]
- Plaque Psoriasis Treated With Tildrakizumab Shown to be Effective in Real-World Settings - MD Magazine - September 29th, 2022 [September 29th, 2022]
- Alumis Announces Initiation of Patient Dosing in Phase 2 Clinical Trial of ESK-001 for the Treatment of Plaque Psoriasis - Business Wire - September 29th, 2022 [September 29th, 2022]
- 15 Items That Will Make Your Life With Psoriatic Arthritis Easier - BlackDoctor.Org - September 29th, 2022 [September 29th, 2022]
- Types of Psoriasis and Their Effects on the Immune System - Cureus - September 27th, 2022 [September 27th, 2022]
- MoonLake Immunotherapeutics to initiate global Phase 2 study of the Nanobody sonelokimab in patients with active psoriatic arthritis - BioSpace - September 27th, 2022 [September 27th, 2022]
- How diversity and inclusion continues to be incorporated in dermatology - PMLiVE - September 27th, 2022 [September 27th, 2022]
- Arcutis Announces Topline Results From ARRECTOR Pivotal Phase 3 Trial Of Roflumilast Foam 0.3% In Scalp A - Benzinga - September 27th, 2022 [September 27th, 2022]
- Psoriasis Treatment Market Size to Hit USD 51.24 Bn by 2030 - GlobeNewswire - August 15th, 2022 [August 15th, 2022]
- Ventyx Sees Initiation Of Mid-Stage Psoriasis Study In Q4 2022 Following Positive Data From Initial-Stage - Benzinga - August 15th, 2022 [August 15th, 2022]