PDE4

New Data from Arcutis’ STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis Presented at European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Friday, September 9, 2022
PDE4, NDA, Safety, IGA, Form 10-K, Dermatitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Study, Time, Doctor of Philosophy, Seborrhoeic dermatitis, Nose, U.S. Securities and Exchange Commission, Risk, Itch, Academy, P92, FAAD, Week, Food, LinkedIn, SEC, Psoriasis, Human, GLOBE, Scalp reduction, Nasdaq, Company, FDA, Atopic dermatitis, Journal of the European Academy of Dermatology and Venereology, Twitter, Face, Congress, Scalp, Eyelid, Eyebrow, Patient, Pharmaceutical industry, Cosmetics, Venereology, Facebook, Dermatology

Roflumilast foam demonstrated strong efficacy across multiple endpoints, including 50% of individuals with seborrheic dermatitis achieving IGA clear at week 8.

Key Points: 
  • Roflumilast foam demonstrated strong efficacy across multiple endpoints, including 50% of individuals with seborrheic dermatitis achieving IGA clear at week 8.
  • Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on all secondary endpoints in the trial, including itch, scaling, and erythema (redness).
  • (63.6% with roflumilast foam vs 42.3% vehicle (P=0.0002))
    More than 50% of individuals treated with roflumilast foam achieved an erythema score of 0 at week 8.
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

New Data from Arcutis’ Topical Roflumilast Clinical Program Presented at the European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Tuesday, September 6, 2022
PDE4, NDA, Safety, Form 10-K, Dermatitis, Time, U.S. Securities and Exchange Commission, Risk, FAAD, LinkedIn, SEC, Psoriasis, GLOBE, Journal of the European Academy of Dermatology and Venereology, Nasdaq, Company, FDA, Atopic dermatitis, News, Twitter, CEST, 2021 Essex County Council election, Face, Congress, Plaque, Scalp, Private Securities Litigation Reform Act, Patient, Pharmaceutical industry, Venereology, Facebook, Dermatology

Specifically, new data from the STRATUM Phase 3 pivotal trial of roflumilast foam in seborrheic dermatitis will be presented in a late-breaking news session.

Key Points: 
  • Specifically, new data from the STRATUM Phase 3 pivotal trial of roflumilast foam in seborrheic dermatitis will be presented in a late-breaking news session.
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast which the Company is developing for both seborrheic dermatitis and scalp and body 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.
  • Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

Arcutis Completes Enrollment in INTEGUMENT-2 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis

Retrieved on: 
Tuesday, August 23, 2022
Irritant, PDE4, Safety, IGA, Eczema Area and Severity Index, Atopic dermatitis, Dermatitis, Atopy, Time, Doctor of Philosophy, Disease, U.S. Securities and Exchange Commission, Risk, Itch, New Drug Application, FAAD, Week, Rash, Body surface area, LinkedIn, Skin, SEC, Success, Psoriasis, Allergen, Comparison (grammar), Validation, MD, GLOBE, Nasdaq, Company, FDA, COPD, Twitter, AD, Face, Shanda, Dermatology, Experimental cancer treatment, Patient, Health insurance, Pharmaceutical industry, Vaccine, Facebook

Roumilast cream is a once daily topical formulation of roumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

Key Points: 
  • Roumilast cream is a once daily topical formulation of roumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).
  • The Company completed enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-1, earlier in August 2022, with topline data from both trials expected by end of 2022.
  • Atopic dermatitis is the most common type of eczema, aecting approximately 9.6 million children and 16.5 million adults in the United States.
  • We are excited to have completed enrollment in the second of two phase 3 pivotal trials with roflumilast cream 0.15% in individuals with atopic dermatitis age six years and older, just weeks after closing enrollment for INTEGUMENT-1.

Arcutis Launches ZORYVE™ (Roflumilast) Cream 0.3% in the United States for Treatment of Plaque Psoriasis in Individuals Age 12 and Older

Retrieved on: 
Wednesday, August 10, 2022
FDA, U.S. Securities and Exchange Commission, Psoriasis, Dermatology, Ageing, Pharmacy, PAP, CEO, GLOBE, Private Securities Litigation Reform Act, SEC, PDE4, Patient, Twitter, Program, Dermatitis, Risk, NASDAQ, Atopic dermatitis, Nasdaq, LinkedIn, Pharmaceutical industry, Health insurance, Facebook

We are excited to make ZORYVE, our first commercial product, available as an innovative topical therapy to individuals in the United States who are currently living with plaque psoriasis.

Key Points: 
  • We are excited to make ZORYVE, our first commercial product, available as an innovative topical therapy to individuals in the United States who are currently living with plaque psoriasis.
  • The availability of ZORYVE so quickly following approval is a reflection of the strength of Arcutis manufacturing and commercial operations.
  • On July 29, Arcutis announced that the FDA had approved ZORYVE for both adults and adolescents with plaque psoriasis.
  • ZORYVE is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Arcutis Announces Second Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, August 4, 2022
Janus, FDA, U.S. Securities and Exchange Commission, Psoriasis, Dermatology, NDA, GLOBE, R, SEC, Clinical trial, IND, Scalp, PDE4, Patient, Review, Company, Twitter, Dermatitis, NDS, Skin, Health Canada, G&A, Atopic dermatitis, Research, Shanda, JAK1, Food and Drug Administration, Nasdaq, LinkedIn, New Drug Application, Food, Vitiligo, Investigational New Drug, Pharmaceutical industry, Fine chemical, Cosmetics, Facebook

Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022.

Key Points: 
  • Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022.
  • Arcutis has established operations in Canada and is building a strong team to support the approval and launch.
  • In April 2022, Arcutis announced the completion of enrollment of the sole pivotal Phase 3 trial (ARRECTOR) for the treatment of scalp and body psoriasis, with topline data anticipated late in the third quarter or early in the fourth quarter of 2022.
  • General and administrative (G&A) expenses for the quarter ended June30, 2022 were $27.6 million compared to $11.3 million for the corresponding period in 2021.

Arcutis Completes Enrollment in INTEGUMENT-1 Pivotal Phase 3 Trial of Roflumilast Cream in Atopic Dermatitis

Retrieved on: 
Thursday, August 4, 2022
Dermatitis, Comparison (grammar), Form 10-K, Inflammation, Atopic dermatitis, Skin, COPD, Allergen, Eczema Area and Severity Index, Success, Patient, U.S. Securities and Exchange Commission, Company, FAAD, Validation, Nasdaq, Safety, FDA, LinkedIn, Disease, IGA, Rash, Atopy, Psoriasis, Experimental cancer treatment, Irritant, Risk, Week, Time, Face, AD, PDE4, GLOBE, New Drug Application, Twitter, MD, Doctor of Philosophy, Dermatology, Body surface area, Shanda, SEC, Health insurance, Vaccine, Pharmaceutical industry, Medical imaging, Facebook, Pediatrics

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

Key Points: 
  • Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).
  • The Company is continuing enrollment in an identically designed pivotal Phase 3 trial, INTEGUMENT-2, with topline data from both trials expected by end of 2022.
  • We believe roflumilast cream, if approved, has the potential to be an effective and well-tolerated once-daily non-steroidal therapy for individuals with atopic dermatitis.
  • Arcutis is enrolling a third pivotal Phase 3 trial, the INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients (INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children two to five years of age with mild to moderate AD.

Cerevel Therapeutics Reports Second Quarter 2022 Financial Results and Business Updates

Retrieved on: 
Monday, August 1, 2022
PIN, Brain, GLOBE, Lists of Palestinian rocket attacks on Israel, Anxiety disorder, Research, Schizophrenia, Forward-looking statement, SEC, Panic disorder, KORA, Intention, PDE4, Marketing, Therapy, MDD, COVID-19, Safety, Volunteering, Positive, Conference, Total, Clinical trial, Biotechnology, PAM, Epilepsy, Drug development, Seizure, FDA, Conference call, Patient, Pharmacokinetics, Psychosis, PANSS, Terminology, GABAA, Growth, Lists of diseases, Society, G&A, Pharmaceutical industry, Cryptocurrency, Medical device, Residential care, Copper

ET

Key Points: 
  • ET
    CAMBRIDGE, Mass., Aug. 01, 2022 (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 quarter ended June 30, 2022 and provided key pipeline and business updates.
  • In June 2022, Cerevel initiated its Phase 2 program in schizophrenia:
    Cerevel is conducting two adequately-powered placebo-controlled Phase 2 trials, known as EMPOWER-1 and EMPOWER-2.
  • Cerevel expects to initiate a 52-week open-label safety extension trial, EMPOWER-3, in the third quarter of 2022.
  • ET to discuss its second quarter 2022 financial results and pipeline updates.

FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older

Retrieved on: 
Friday, July 29, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conditional sentence, IGA, GLOBE, PAP, Sex, Â, Food, Itch, CEO, Icahn School of Medicine at Mount Sinai, New Drug Application, Plaque, PDE4, NDA, Therapy, Safety, NASDAQ, EDT, Webcast, Disease, FDA, Company, National Psoriasis Foundation, Patient, Psoriasis, Week, Kimberley, Mount Sinai, Face, Program, FAAD, Pharmaceutical industry, Dermatology

ZORYVE a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation is uniquely formulated to simplify disease management for people living with plaque psoriasis.

Key Points: 
  • ZORYVE a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation is uniquely formulated to simplify disease management for people living with plaque psoriasis.
  • ZORYVE is the only topical for which data focused on the treatment of intertriginous plaques a common area affected by plaque psoriasis have been specifically generated.
  • As a result, individuals with psoriasis are often prescribed multiple topical medications for different areas, which makes for a complicated treatment regimen.
  • ZORYVE is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

MediciNova Initiates Clinical Evaluation of a New Parenteral Formulation of MN-166 (ibudilast)

Retrieved on: 
Friday, July 22, 2022
IPF, Multiple sclerosis, GLOBE, MPH, Injection, Glioblastoma, U.S. Securities and Exchange Commission, Amyotrophic lateral sclerosis, Trial of the century, Neurodegeneration, Code, Acute respiratory distress syndrome, Intellectual property, Form 8-K, Private Securities Litigation Reform Act, NAFLD, PDE4, Risk, Failure, NASDAQ, DCM, CIPN, MS, ALS, FDA, MD, Security (finance), Tokyo Stock Exchange, Patient, Pharmacokinetics, Annual report, Chemotherapy-induced peripheral neuropathy, Idiopathic pulmonary fibrosis, Non-alcoholic fatty liver disease, Nasdaq, Form 10-K, MIF, Pharmaceutical industry, Doctor of Philosophy

The newly developed MN-166 (ibudilast) formulation will provide an additional option for health care providers to administer MN-166 (ibudilast), in addition to the current oral formulation.

Key Points: 
  • The newly developed MN-166 (ibudilast) formulation will provide an additional option for health care providers to administer MN-166 (ibudilast), in addition to the current oral formulation.
  • With MN-166 expected to be effective to treat a variety of diseases, we believe expanding to a parenteral formulation increases the feasibility of treating more target indications, thus increasing the value of MN-166.
  • Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development.
  • MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Arcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

Retrieved on: 
Monday, July 11, 2022
Safety, Plaque, NDS, CEO, PDE4, Psoriasis, Dermatology, IGA, Nasdaq, Review, GLOBE, Patient, Health Canada, Pharmaceutical industry

We look forward to working closely with Health Canada during the review process.

Key Points: 
  • We look forward to working closely with Health Canada during the review process.
  • Arcutis NDS submission is supported by positive data from Arcutis pivotal Phase 3 program and two long-term open label studies.
  • The safety and efficacy of roflumilast cream remain under investigation and market authorization in Canada has not yet been obtained.
  • A new drug application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adolescents and adults is also under review by the U.S. Food & Drug Administration (FDA).