PDE4

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

Retrieved on: 
Saturday, March 18, 2023
PDE4, American Academy of Dermatology, Arm, AD, Atopic dermatitis, American Academy, AAD, Week, Vaccine

Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Key Points: 
  • Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.
  • Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4.
  • “Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis.
  • Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.

Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 28, 2023
Janus, Skin, Hair, SG, Psoriasis, ESG, Research, Vitiligo, Acquisition, JAK1, Webcast, FDA, Patient, R, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biophysical environment, Scalp, NDA, Growth, Inflammation, PDE4, Prescription, New Drug Application, Shanda, Pharmacy, Alopecia areata, Food, Ageing, Dermatitis, Atopic dermatitis, Video game, Health insurance, Pharmaceutical industry, Cosmetics, Cryptocurrency

In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older.

Key Points: 
  • In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Net cash used in operating activities was $71.1 during the fourth quarter and $257.7 million during the full year 2022.
  • Arcutis management will host a conference call and webcast today at 4:30pm ET to discuss the financial results for the quarter and provide a business update.

Cerevel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates

Retrieved on: 
Wednesday, February 22, 2023
D, Panic disorder, Brain, Investment, PIN, DSM-IV codes, Conference call, Safety, Disorder, PAM, Schizophrenia, Therapy, Hallucination, FDA, Psychiatry, Growth, GABAA, PDE4, Research, Epilepsy, KORA, Conference, Delusion, Blood pressure, Pharmacokinetics, Cryptocurrency, Pharmaceutical industry, Video game, G&A

ET

Key Points: 
  • ET
    CAMBRIDGE, Mass., Feb. 22, 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 fourth quarter and full year ended December 31, 2022 and provided key pipeline and business updates.
  • In June 2022, Cerevel initiated its Phase 2 program in schizophrenia, in which emraclidine is being studied as a once-daily medication without the need for titration.
  • Cerevel expects G&A expenses to remain relatively consistent for 2023, as compared to the fourth quarter of 2022.
  • ET to discuss its fourth quarter and full year 2022 financial results and pipeline updates.

Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents

Retrieved on: 
Tuesday, February 21, 2023
Nose, NDA, Week, Eyebrow, Eyelid, Human, Safety, Face, Scalp reduction, Study, Food, Dermatitis, Seborrhoeic dermatitis, Disease, FDA, Scalp, PDE4, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Cosmetics

Arcutis recognizes the urgent need for a new therapy that could enable symptom control, easier management, and increased adherence,” said Patrick Burnett M.D., Ph.D, F.A.A.D., Chief Medical Officer at Arcutis.

Key Points: 
  • Arcutis recognizes the urgent need for a new therapy that could enable symptom control, easier management, and increased adherence,” said Patrick Burnett M.D., Ph.D, F.A.A.D., Chief Medical Officer at Arcutis.
  • “Roflumilast foam, which is being developed as an easy-to-use, steroid free, once-daily topical treatment, has been shown in clinical trials to be effective and well tolerated.
  • “There has not been a once-daily steroid-free topical prescription treatment approved for seborrheic dermatitis in over a decade.
  • The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) was a Phase 3, parallel group, double blind, vehicle-controlled study evaluating the safety and efficacy of roflumilast foam 0.3%.

Giiant Pharma Receives Financial Support From the US Crohn’s and Colitis Foundation

Retrieved on: 
Tuesday, January 10, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, IND, Inflammatory Bowel Diseases, Colitis, PDE4, Ulcerative colitis, IBD, Therapy, Patient, US, Multimedia, Pharmaceutical industry

Giiant Pharma Inc., a Canadian, preclinical-stage biotech company, today announced that the Company will receive financial support from the US Crohn’s and Colitis Foundation, through its IBD Ventures program, for an amount up to US$ 500,000.

Key Points: 
  • Giiant Pharma Inc., a Canadian, preclinical-stage biotech company, today announced that the Company will receive financial support from the US Crohn’s and Colitis Foundation, through its IBD Ventures program, for an amount up to US$ 500,000.
  • This financing will support the development of GT-2108, an orally administered, gut-restricted, colon-specific PDE4 (phosphodiesterase-4) inhibitor prodrug for patients affected by moderate-to-severe ulcerative colitis.
  • “The financial support of the Crohn’s and Colitis Foundation demonstrates the strong Giiant’s value proposition of its platform for patients suffering from inflammatory bowel diseases, including ulcerative colitis” says Dr. Maxime Ranger, President and CEO of Giiant Pharma Inc.
    With this financing, Giiant Pharma will pursue its IND-enabling preclinical program with its lead candidate, GT-2108, in view of an IND filing by Q2 2024.
  • The Company is currently in discussion with potential pharmaceutical partners to co-develop and accelerate the GT-2108 program.

Arcutis Presents New Phase 2 Long-Term Data Showing Sustained Efficacy and Clearance for a Median of 10 Months with Roflumilast Cream in Adults with Chronic Plaque Psoriasis

Retrieved on: 
Saturday, January 14, 2023
Kimberley, FAAD, Common, URTI, IGA, Therapy, Icahn School of Medicine at Mount Sinai, Safety, Sinusitis, PDE4, MD, FDA, Irritation, Psoriasis, Urinary tract infection, Patient, Tachyphylaxis, AES, US Foods, Doctor of Philosophy, Mount Sinai, Cosmetics, Pharmaceutical industry, Dermatology

Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.

Key Points: 
  • Roflumilast cream 0.3% (ZORYVE®) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the US Food and Drug Administration in July 2022.
  • Roflumilast cream was safe and very well tolerated, with the majority of adverse events (AEs) mild-to-moderate in severity.
  • Additional key findings following 52 weeks of treatment with roflumilast cream 0.3% include:
    IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve participants.
  • 1Cohort 1 not shown because I-IGA added as study amendment and numbers of patients evaluated are very small at each timepoint.

Cerevel Therapeutics to Present at 41st Annual J.P. Morgan Healthcare Conference and Provide Pipeline Update

Retrieved on: 
Monday, January 9, 2023
Psychosis, Hallucination, GABAA, Brain, Therapy, Lorazepam, Panic disorder, PAM, KORA, Pharmacokinetics, Safety, Blood pressure, PDE4, FDA, MDD, Conference, Delusion, Patient, Anxiety disorder, Epilepsy, Volunteering, Schizophrenia, Pharmaceutical industry, Residential care

CAMBRIDGE, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, will present tomorrow, Tuesday, January 10 at 8:15 a.m. PT/11:15 a.m. ET at the 41st Annual J.P. Morgan Healthcare Conference. During the presentation, Cerevel chairperson and chief executive officer, Dr. Tony Coles, will review the Company’s lead programs and upcoming milestones. A question-and-answer session will follow the presentation.

Key Points: 
  • ET at the 41st Annual J.P. Morgan Healthcare Conference.
  • During the presentation, Cerevel chairperson and chief executive officer, Dr. Tony Coles, will review the Company’s lead programs and upcoming milestones.
  • To support a potential registrational package for emraclidine in schizophrenia, Cerevel is prioritizing the completion of nonclinical and clinical pharmacology studies.
  • The live webcast and accompanying slides can be accessed on the Investor Relations section of the Cerevel Therapeutics website here .

Arcutis Submits Supplemental New Drug Application for ZORYVE® (roflumilast) Cream 0.3% for Expanded Indication for the Treatment of Plaque Psoriasis in Children Down to 2 Years of Age

Retrieved on: 
Monday, December 19, 2022
Ageing, Propylene glycol, Food, FAAD, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Irritant, Excipient, MUSE, Face, Shanda, Patient, Safety, FDA, Psoriasis, Dermatology, Doctor of Philosophy, PDE4, Pharmaceutical industry

As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.

Key Points: 
  • As with adults and adolescents, plaque psoriasis is the most common form of psoriasis in children 2 to 11 years of age, with very similar clinical features.
  • ZORYVE was approved by the FDA in July 2022 for the topical treatment of plaque psoriasis in adults and adolescents 12 years of age and older.
  • “Safety and tolerability are critically important in the treatment of children, and today young children lack treatment options for plaque psoriasis.
  • Arcutis worked with the FDA on the design of the MUSE studies, which are intended to fulfill FDA post-marketing requirements for ZORYVE.

Arcutis Announces Positive Topline Results from Second Atopic Dermatitis Pivotal Phase 3 Trial of Roflumilast Cream in Adults and Children Aged 6 and Older

Retrieved on: 
Monday, December 12, 2022
PDE4, AD, Week, Atopic dermatitis, Medical imaging

“Adults and children who suffer with atopic dermatitis are in need of non-steroidal topical treatment options that are safe, well-tolerated, and suitable for long-term use.

Key Points: 
  • “Adults and children who suffer with atopic dermatitis are in need of non-steroidal topical treatment options that are safe, well-tolerated, and suitable for long-term use.
  • AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States.
  • “We are very pleased with these positive findings from INTEGUMENT-2, our second of two Phase 3 pivotal trials with roflumilast cream 0.15% in individuals with mild to moderate atopic dermatitis aged 6 years and older.
  • Arcutis investigated roflumilast cream 0.15% in adults and children aged 6 and over with mild to moderate AD in two identical pivotal Phase 3 studies, INTEGUMENT-1 and INTEGUMENT-2.

Study Showing Significant Improvements in Itch and Itch-Related Sleep Loss with Roflumilast Cream in Adults with Plaque Psoriasis Published in American Journal of Clinical Dermatology

Retrieved on: 
Monday, November 28, 2022
Linda, Cream, Henry Ford Health System, PSD, Doctor of Philosophy, Henry Ford, DLQI, FAAD, PDE4, Safety, Week, Patient, Itch, Sleep, Paper, Dermatology Life Quality Index, American Journal of Clinical Dermatology, Disease, MD, Dermatitis, Psoriasis, American Journal, Atopic dermatitis, FDA, NRS, Silviculture, Pharmaceutical industry, Cosmetics, Hospital, Dermatology

In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects ranging from ages 18 to 89 years were randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle in a 1:1:1 ratio.

Key Points: 
  • In the parallel-group, double-blind, vehicle-controlled phase 2b clinical trial, 331 subjects ranging from ages 18 to 89 years were randomized to roflumilast 0.3% cream, roflumilast 0.15% cream or vehicle in a 1:1:1 ratio.
  • Roflumilast cream or vehicle was applied once daily to all psoriasis lesions for 12 weeks.
  • In July 2022, ZORYVE (roflumilast) cream 0.3% was approved for the topical use in adults and adolescents with mild to severe plaque psoriasis, including intertriginous psoriasis.
  • ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.