PDE4

FDA Accepts Arcutis’ Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6

Retrieved on: 
Wednesday, November 29, 2023
Atopic dermatitis, Food, Adolescence, Shanda, FDA, PDUFA, Success, Prevalence, Disease, Pediatrics, Atopy, PDE4, Patient, Safety, Skin, Pharmaceutical industry

The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.

Key Points: 
  • The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.
  • “Atopic dermatitis is a chronic and recurring inflammatory skin condition that requires therapy that is effective, tolerable, and suitable for long-term use by both adults and children.
  • INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.
  • The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Palisade Bio Reports Third Quarter 2023 Financial Results and Provides Business Outlook

Retrieved on: 
Friday, November 10, 2023
Ulcerative colitis, Doctor of Philosophy, Therapy, Safety, IBD, PDE4, UC, Palisade

Carlsbad, CA, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today reported its financial results for the third quarter 2023 and provided a business outlook.

Key Points: 
  • Carlsbad, CA, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today reported its financial results for the third quarter 2023 and provided a business outlook.
  • “The past quarter was marked by a transformative transaction for Palisade.
  • We believe that novel therapeutics which demonstrate safety and efficacy have the potential to gain significant market share.
  • Palisade has the only PDE4 inhibitor prodrug under development for the treatment of ulcerative colitis, our lead indication,” commented J.D.

Arcutis Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, November 3, 2023
Janus, FDA, Psoriasis, Research, JAK1, Patent, ESG, GTN, SG, Human, Acquisition, Environmental, social, and corporate governance, Biophysical environment, United States Patent and Trademark Office, Inflammation, Hair, R, Senior, Growth, Prescription, Marketing, Shanda, Webcast, SLR, New Drug Application, Scalp, PDE4, NDA, Atopic dermatitis, Patient, Dermatitis, Acceleration, Alopecia areata, Video game, Pharmaceutical industry, Security (finance), Fine chemical, Vaccine, Cosmetics

The Company anticipates further GTN improvement in the fourth quarter of 2023.

Key Points: 
  • The Company anticipates further GTN improvement in the fourth quarter of 2023.
  • In October 2023, Arcutis received FDA approval for ZORYVE for an expanded indication for the treatment of plaque psoriasis in children down to 6 years of age.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR Pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Arcutis management will host a conference call and webcast today at 8:30am ET to discuss the financial results for the quarter and provide a business update.

Cerevel Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Wednesday, November 1, 2023
FDA, Research, Psychiatry, PIN, Hallucination, Tavapadon, PAM, DSM-IV codes, Conference, Exercise, Volunteering, Pharmacokinetics, GABAA, Panic disorder, Schizophrenia, Disorder, KORA, ADAPT, Delusion, PDE4, Brain, Safety, Epilepsy, Total, Therapy, Conference call, Broadcasting, Pharmaceutical industry, Cryptocurrency, Airline

CAMBRIDGE, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics, (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the third quarter ended September 30, 2023 and provided key pipeline and business updates.

Key Points: 
  • ET
    CAMBRIDGE, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics , (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the third quarter ended September 30, 2023 and provided key pipeline and business updates.
  • Leveraging its deep understanding of neurocircuitry and targeted receptor subtype selectivity, Cerevel is advancing its broad and diverse pipeline of novel neuroscience product candidates.
  • Cerevel is conducting the REALIZE trial, a Phase 2 proof-of-concept trial in focal epilepsy, and a corresponding open-label safety extension trial.
  • ET to discuss its third quarter 2023 financial results and key pipeline and business updates.

Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Friday, October 13, 2023
Congress, Pain, Scalp, PSD, Week, PDE4, Patient, Face, Pharmaceutical industry

The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.

Key Points: 
  • The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.
  • New data presented in Berlin demonstrate improvements in both scalp and body itch.
  • Importantly, a rapid and significant improvement in scalp itch was observed 24 hours following first application as measured by SI-NRS (P=0.0164).
  • Overall, the most common adverse events in the study population (≥2%) included headache (4.6%), diarrhea (3.2%), COVID-19 (2.8%), and nausea (2.1%).

Meiji Seika Pharma Presents Positive Findings from Phase II Study of ME3183, Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Plaque Psoriasis at EADV Congress 2023

Retrieved on: 
Friday, October 13, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Congress, European Association for the Study of the Liver, PASI, Meiji, BID, Outline, Safety, Psoriasis, Psoriasis Area and Severity Index, PDE4, QD, Traffic barrier, Patient, Pharmaceutical industry, Dermatology, Venereology

In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27).

Key Points: 
  • In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27).
  • Mean Psoriasis Area and Severity Index (PASI) score at baseline was 15.9–17.6 and 16.8 in the ME3183 and placebo groups, respectively.
  • In conclusion, ME3183 administered orally was effective in the treatment of plaque psoriasis and had an acceptable safety profile.
  • Meiji strives to provide efficacious and safe treatment for unmet medical needs, such as psoriasis and other autoimmune diseases.

UNION therapeutics announces presentation of new data on orismilast at the EADV Congress 2023

Retrieved on: 
Friday, October 6, 2023
Congress, Journal of the European Academy of Dermatology and Venereology, Biomarker, POC, A/S, Zealand University Hospital, Roskilde, MD, Therapy, Atopic dermatitis, Infection, Safety, Psoriasis, UNION, Patient, OSIRIS, PDE4, Hidradenitis suppurativa, Skin, IIT, HS, Pharmaceutical industry, Management, Doctor of Philosophy, Dermatology

New data from the OSIRIS investigator-initiated (IIT) proof of concept open label, single center study of oral orismilast in HS will be presented by the investigator Professor, Dr. Gregor Jemec.

Key Points: 
  • New data from the OSIRIS investigator-initiated (IIT) proof of concept open label, single center study of oral orismilast in HS will be presented by the investigator Professor, Dr. Gregor Jemec.
  • Additionally, two e-posters from the IASOS Phase 2b study will be presented at the EADV Congress 2023, describing the clinical efficacy and safety of orismilast and its impact on biomarkers measured in the skin of moderate-to-severe psoriasis patients.
  • Kim Kjøller, Chief Executive Officer of UNION therapeutics adds:
    "We are pleased that results from the OSIRIS IIT PoC study have been selected as a late-breaking presentation at the EADV Congress 2023.
  • Additionally, we are super excited about presenting two posters with new data on orismilast at the Congress.

UNION therapeutics announces presentation of new data on orismilast at the EADV Congress 2023

Retrieved on: 
Friday, October 6, 2023
Congress, Journal of the European Academy of Dermatology and Venereology, Biomarker, POC, A/S, Zealand University Hospital, Roskilde, MD, Therapy, Atopic dermatitis, Infection, Safety, Psoriasis, UNION, Patient, OSIRIS, PDE4, Hidradenitis suppurativa, Skin, IIT, HS, Pharmaceutical industry, Management, Doctor of Philosophy, Dermatology

New data from the OSIRIS investigator-initiated (IIT) proof of concept open label, single center study of oral orismilast in HS will be presented by the investigator Professor, Dr. Gregor Jemec.

Key Points: 
  • New data from the OSIRIS investigator-initiated (IIT) proof of concept open label, single center study of oral orismilast in HS will be presented by the investigator Professor, Dr. Gregor Jemec.
  • Additionally, two e-posters from the IASOS Phase 2b study will be presented at the EADV Congress 2023, describing the clinical efficacy and safety of orismilast and its impact on biomarkers measured in the skin of moderate-to-severe psoriasis patients.
  • Kim Kjøller, Chief Executive Officer of UNION therapeutics adds:
    "We are pleased that results from the OSIRIS IIT PoC study have been selected as a late-breaking presentation at the EADV Congress 2023.
  • Additionally, we are super excited about presenting two posters with new data on orismilast at the Congress.

Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at CHEST 2023

Retrieved on: 
Tuesday, October 3, 2023
COPD, PDE4, Maintenance, University, Quality of life, PDE3, University of Pittsburgh School of Medicine, Associate, Chronic obstructive pulmonary disease, VRNA, US, MD, Patient, Risk, PDUFA, Wilfrid Sellars, Pharmaceutical industry, Medicine

LONDON and RALEIGH, N.C., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces four presentations on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at CHEST Annual Meeting (“CHEST”) 2023. The data are published in the CHEST Annual Meeting on-line supplement. Ensifentrine is Verona Pharma’s investigational dual PDE3 and PDE4 inhibitor, a potential first-in-class product currently under review by the US FDA for the maintenance treatment of COPD.

Key Points: 
  • The data are published in the CHEST Annual Meeting on-line supplement.
  • Ensifentrine is Verona Pharma’s investigational dual PDE3 and PDE4 inhibitor, a potential first-in-class product currently under review by the US FDA for the maintenance treatment of COPD.
  • Ensifentrine’s combined bronchodilator and non-steroidal anti-inflammatory activity could lead to meaningful benefits in a broad population of COPD patients.
  • Details of Verona Pharma’s presentations are listed below and linked to the CHEST website:
    For further information please contact:

Arcutis Submits Roflumilast Cream 0.15% Supplemental New Drug Application to the FDA for the Treatment of Atopic Dermatitis in Adults and Children Ages 6 Years and Older

Retrieved on: 
Tuesday, September 12, 2023
PDE4, Flare, Disease, Irritant, Prevalence, Week, Oregon Health & Science University, Ethanol, Dermatitis, Parent, George Washington University School of Engineering and Applied Science, New Drug Application, George Washington University School of Medicine & Health Sciences, Propylene glycol, Skin, Atopic dermatitis, FAAD, Excipient, Oregon Health Plan, IGA, MCR, Shanda, MD, Patient, Risk, SUNY Downstate Health Sciences University, Outline of health sciences, AD, FDA, MPH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Success, Vaccine, Pharmaceutical industry, Dermatology, Doctor of Philosophy

In clinical studies, once-daily roflumilast cream provided rapid clearance of the disease.

Key Points: 
  • In clinical studies, once-daily roflumilast cream provided rapid clearance of the disease.
  • Roflumilast cream is uniquely formulated with HydroARQ Technology™ as a non-greasy emollient cream that absorbs quickly and does not disrupt the skin barrier.
  • “Topical roflumilast cream was intentionally formulated with the atopic dermatitis patient in mind, and does not contain excipients that disrupt skin-barrier integrity or are common contact allergens.
  • I would like to thank the team at Arcutis for their incredible hard work and dedication,” added Watanabe.