PDE4

Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis

Retrieved on: 
Monday, October 4, 2021
PDE4, Food, NDA, Silver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Plaque, Mark (given name), FDA, Patient, Population, Physician, Scalp, Itchy, CEO, Face, Psoriasis, Dermatology, Safety, Nasdaq, Time, Skin, GLOBE, Medical imaging, Pharmaceutical industry

Roflumilast cream, a non-steroidal treatment intended for chronic use, would be the first and only topical PDE4 inhibitor for psoriasis, if approved.

Key Points: 
  • Roflumilast cream, a non-steroidal treatment intended for chronic use, would be the first and only topical PDE4 inhibitor for psoriasis, if approved.
  • Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses.
  • If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis.
  • Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor, roflumilast.

Arcutis Expands Patent Portfolio with Roflumilast Pharmacokinetics Patent

Retrieved on: 
Tuesday, September 28, 2021
PDE4, U.S. Securities and Exchange Commission, Patent, Standard of care, Risk, NDA, Half-life, Patient, LinkedIn, Form 10-K, United States Patent and Trademark Office, GLOBE, Twitter, Psoriasis, Atopic dermatitis, Clinical trial, Dermatology, Safety, Dermatitis, Nasdaq, SEC, Pharmaceutical industry

Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), to treat psoriasis, atopic dermatitis, and seborrheic dermatitis.

Key Points: 
  • Arcutis is developing topical cream and foam formulations of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4), to treat psoriasis, atopic dermatitis, and seborrheic dermatitis.
  • Clinical trial data has shown that Arcutis topical roflumilast formulations are uniquely suited to address unmet patient needs without difficult trade-offs between efficacy, safety, and tolerability.
  • We believe this new patent represents important additional protection for our unique, proprietary topical roflumilast treatment, and is separate and distinct from our formulation patents.
  • This new patent also further validates Arcutis dermatological development platform that builds on our deep dermatological expertise, which includes one of the foremost topical formulators and five dermatology clinicians on staff.

UNION therapeutics and Innovent Biologics enter into strategic collaboration and license agreement for orismilast, a next-generation PDE4 inhibitor for inflammatory dermatology conditions

Retrieved on: 
Tuesday, September 28, 2021
PDE4, Infection, BLA, Review, USD, Metabolism, NDA, MD Anderson Cancer Center, Stock exchange, Hidradenitis suppurativa, Therapy, CMC, HKEX, Cancer, Biologics license application, Patient, NMPA, Microbiology, Population, Control, Marketing, Company, Psoriasis, Prevalence, Sintilimab, Autoimmunity, SAN, Eli Lilly and Company, Atopic dermatitis, Bevacizumab, Leo Pharma, Integrity, Research, Chemistry, Spotlight Innovation, D, Safety, Motherboard, UNION, Pharmaceutical industry

"We are very pleased to enter a collaboration with UNION.

Key Points: 
  • "We are very pleased to enter a collaboration with UNION.
  • This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio.
  • Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts.
  • The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development.

UNION therapeutics and Innovent Biologics enter into strategic collaboration and license agreement for orismilast, a next-generation PDE4 inhibitor for inflammatory dermatology conditions

Retrieved on: 
Tuesday, September 28, 2021
PDE4, Infection, BLA, Review, USD, Metabolism, NDA, MD Anderson Cancer Center, Stock exchange, Therapy, Hidradenitis suppurativa, CMC, HKEX, Cancer, Biologics license application, Patient, NMPA, Microbiology, Population, Control, Marketing, Company, Psoriasis, Prevalence, Sintilimab, Autoimmunity, SAN, Eli Lilly and Company, Atopic dermatitis, Bevacizumab, Leo Pharma, Integrity, Research, Chemistry, Spotlight Innovation, D, Safety, Motherboard, UNION, Pharmaceutical industry

"We are very pleased to enter a collaboration with UNION.

Key Points: 
  • "We are very pleased to enter a collaboration with UNION.
  • This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio.
  • Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts.
  • The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with seven programs in clinical development.

Innovent and UNION Therapeutics Enter into Strategic Collaboration and License Agreement for Orismilast, a Next-generation PDE4 Inhibitor for Inflammatory Dermatology Conditions

Retrieved on: 
Tuesday, September 28, 2021
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Dr. Yongjun Liu, President of Innovent, said: "We are very pleased to enter a collaboration with UNION.

Key Points: 
  • Dr. Yongjun Liu, President of Innovent, said: "We are very pleased to enter a collaboration with UNION.
  • This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio.
  • Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020.
  • Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts.

New Topical Roflumilast Data Presented at the European Academy of Dermatology and Venereology (EADV) Congress

Retrieved on: 
Monday, September 27, 2021
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Topical roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases.

Key Points: 
  • Topical roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases.
  • Data continue to demonstrate that topical roflumilast delivers superior efficacy over vehicle across multiple indications while improving the severity and impact of itch, said Patrick Burnett , M.D., Ph.D., FAAD, Chief Medical Officer, Arcutis.
  • Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors.
  • The companys lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

Retrieved on: 
Thursday, September 23, 2021
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HIGH POINT, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced results of a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, in healthy adults. The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days. Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events. vTv therefore believes that the current safety profile allows it to move forward in development with a drug that may achieve anti-inflammatory and anti-psoriatic responses without the significant safety issues of other PDE4 inhibitors. Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.

Key Points: 
  • Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.
  • With these results, vTv held a successful pre-IND meeting with the U.S. Food and Drug Administration Division of Dermatology and Dentistry.
  • An oral, once-daily PDE4 inhibitor with robust efficacy, absent adverse events of gastrointestinal distress, would be a significant benefit for patients with psoriasis.
  • vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and psoriasis.

MediciNova Announces MN-166 (ibudilast) ALS Abstract Accepted for Presentation at the 32nd International Symposium on ALS/MND

Retrieved on: 
Monday, August 30, 2021
Badminton Association of India, Tokyo Stock Exchange, Amyotrophic lateral sclerosis, Neurodegeneration, Nasdaq, Private Securities Litigation Reform Act, ALS, MS, Annual report, International Symposium on Graph Drawing, MIF, Quality of life, Observation, Glioblastoma, PDE4, U.S. Securities and Exchange Commission, Life expectancy, Trial of the century, Acute respiratory distress syndrome, GLOBE, Muscle, IPF, Form 8-K, Disease, Chemotherapy-induced peripheral neuropathy, Death, Intellectual property, ALS Association, Fatty liver disease, DCM, Month, NASDAQ, Substance dependence, Safety, Risk, Failure, Patient, Spinal cord, Idiopathic pulmonary fibrosis, Education, NASH, CIPN, FDA, Brain, Association, Code, Security (finance), Form 10-K, Multiple sclerosis, Pharmaceutical industry

The presentation entitled "COMBAT-ALS Phase 2b/3 Trial of MN-166 (ibudilast) in ALS: Trial Update will be given by Kazuko Matsuda, M.D.

Key Points: 
  • The presentation entitled "COMBAT-ALS Phase 2b/3 Trial of MN-166 (ibudilast) in ALS: Trial Update will be given by Kazuko Matsuda, M.D.
  • We are very pleased to present ongoing activities from the COMBAT-ALS trial at the 32nd International Symposium on ALS/MND.
  • As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed.
  • According to the ALS Association, there are approximately 16,000 ALS patients in the U.S. and approximately 5,000 people in the U.S. are diagnosed with ALS each year.

Arcutis Enrolls First Patient in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Scalp and Body Psoriasis

Retrieved on: 
Wednesday, August 25, 2021
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Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Key Points: 
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.
  • In our previous Phase 2b trial, roflumilast foam was demonstrated to be a safe, well-tolerated, and effective potential treatment for scalp and body psoriasis.
  • Topical roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast).
  • The companys lead product candidate, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.

Meiji Completed Phase I Studies and Moves Onto Phase II Study of ME3183, a Selective PDE4 Inhibitor for the Treatment of Psoriasis

Retrieved on: 
Tuesday, August 24, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Phase, Psoriasis, PDE4, Brain, Degenerative disease, Uniloc USA, Inc. v. Microsoft Corp., Patient, Pharmaceutical industry

Based on these results, Meiji plans to initiate a Phase II clinical trial in patients with plaque psoriasis in the United States and Canada in the first quarter of 2022.

Key Points: 
  • Based on these results, Meiji plans to initiate a Phase II clinical trial in patients with plaque psoriasis in the United States and Canada in the first quarter of 2022.
  • ME3183 is an orally-available and selective inhibitor for phosphodiesterase 4 (PDE4) discovered by Meiji.
  • Meiji Pharma USA Inc., a wholly owned subsidiary of Meiji, will be in charge of the Phase II clinical trial.
  • Meiji strives to provide efficacious and safe treatment for unmet medical needs, such as psoriasis and autoimmune diseases.