PDE4

MediciNova Announces Completion of Enrollment in the Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for Acute Respiratory Distress Syndrome

Retrieved on: 
Wednesday, April 13, 2022
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Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "The last enrolled patients last visit has been completed.

Key Points: 
  • Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "The last enrolled patients last visit has been completed.
  • Acute respiratory distress syndrome (ARDS) is a frequently lethal lung condition caused by excessive inflammation for which there are no effective therapies beyond supportive care.
  • In addition, MN-166 (ibudilast) is being evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).
  • MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma, patients at risk of developing acute respiratory distress syndrome (ARDS), and substance dependence.

MediciNova Announces Secondary Analysis of Phase 2 Trial of MN-166 (ibudilast) in Alcohol Use Disorder Published in Alcoholism: Clinical and Experimental Research

Retrieved on: 
Friday, April 8, 2022
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Eligible participants were randomized to MN-166 (ibudilast) or matched placebo and completed daily diary assessments (DDAs) during the two-week period.

Key Points: 
  • Eligible participants were randomized to MN-166 (ibudilast) or matched placebo and completed daily diary assessments (DDAs) during the two-week period.
  • Multilevel models compared the effects of MN-166 (ibudilast) and placebo on subjective alcohol response.
  • We are pleased that the results of this secondary analysis are consistent with the findings from the primary analysis.
  • Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with limited treatment options.

Arcutis Completes Enrollment in ARRECTOR Pivotal Phase 3 Trial of Topical Roflumilast Foam in Scalp and Body Psoriasis

Retrieved on: 
Wednesday, April 6, 2022
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Roflumilast foam is a once-daily, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor (roflumilast).

Key Points: 
  • Roflumilast foam is a once-daily, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor (roflumilast).
  • If successful, the Company believes that this trial will provide sufficient basis to file a supplemental New Drug Application (sNDA) in the U.S. for roflumilast foam in scalp and body psoriasis.
  • The A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis (ARRECTOR) study is a parallel group, double blind, vehicle-controlled pivotal Phase 3 study of the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in subjects with scalp and body psoriasis ages 12 and older.
  • Topical roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast), which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Meiji Seika Pharma: First Patient Dosed in Phase II Study of ME3183, a Selective PDE4 Inhibitor, in Patients with Plaque Psoriasis in the United States and Canada

Retrieved on: 
Thursday, April 7, 2022
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Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Daikichiro Kobayashi, hereinafter Meiji) today announced that the first patient was dosed in Phase II clinical trial of ME3183, a selective phosphodiesterase-4 (PDE4) inhibitor, in patients with plaque psoriasis in the United States and Canada.

Key Points: 
  • Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Daikichiro Kobayashi, hereinafter Meiji) today announced that the first patient was dosed in Phase II clinical trial of ME3183, a selective phosphodiesterase-4 (PDE4) inhibitor, in patients with plaque psoriasis in the United States and Canada.
  • In non-clinical studies, ME3183 showed greater anti-inflammatory effect and its inhibitory effect on TNF- production was approximately 30-fold greater than the existing orally-available PDE4 inhibitor for psoriasis.
  • The Phase I single and multiple dose clinical trials were conducted in healthy volunteers in the United States.
  • One-hundred and twenty-five patients are planned to be enrolled at approximately 30 facilities in the United States and Canada (NCT05268016).

Arcutis Presents New Data on Once-Daily Roflumilast Cream for Plaque Psoriasis from DERMIS Phase 3 Trials at American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 25, 2022
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Roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor (PDE4) being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases, including plaque psoriasis.

Key Points: 
  • Roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor (PDE4) being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases, including plaque psoriasis.
  • Roflumilast cream, if approved, could provide an important new topical therapy option for the millions of patients with chronic plaque psoriasis.
  • In both trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.
  • Roflumilast cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor, roflumilast.

Arcutis’ Roflumilast Foam Demonstrates Clinically Meaningful Results and Patient Quality of Life Improvements in Phase 2 Seborrheic Dermatitis Study

Retrieved on: 
Friday, March 25, 2022
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These data show that investigational roflumilast foam effectively improved and cleared seborrheic dermatitis, while also improving important measures in patients quality of life.

Key Points: 
  • These data show that investigational roflumilast foam effectively improved and cleared seborrheic dermatitis, while also improving important measures in patients quality of life.
  • Roflumilast foam has the potential to become the standard of care for seborrheic dermatitis.
  • The Company recently announced the last subject enrolled in its pivotal Phase 3 STRATUM clinical trial of roflumilast foam in seborrheic dermatitis, with topline data results expected mid-year 2022.
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective PDE4 inhibitor, which the Company is developing for both seborrheic dermatitis and scalp and body psoriasis.

Arcutis Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 22, 2022
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We executed exceptionally well in 2021, delivering strong Phase 3 plaque psoriasis data, initiating three additional Phase 3 programs, and commencing our commercialization efforts.

Key Points: 
  • We executed exceptionally well in 2021, delivering strong Phase 3 plaque psoriasis data, initiating three additional Phase 3 programs, and commencing our commercialization efforts.
  • Patient enrollment continues in the pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1, INTEGUMENT-2, and INTEGUMENT-PED).
  • 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.
  • General and administrative (G&A) expenses for the quarter ended December31, 2021 were $18.7 million compared to $6.7 million for the corresponding period in 2020.

MediciNova Announces MN-166 (ibudilast) Identified as Promising Pharmacotherapy for Alcohol Use Disorder in Drugs

Retrieved on: 
Tuesday, February 22, 2022
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Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with limited treatment options.

Key Points: 
  • Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with limited treatment options.
  • AUD is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using alcohol.
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.
  • MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Arcutis Completes Enrollment of STRATUM Pivotal Phase 3 Trial of Topical Roflumilast Foam in Individuals with Seborrheic Dermatitis

Retrieved on: 
Tuesday, February 1, 2022
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Roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast).

Key Points: 
  • Roflumilast foam is a once-daily, topical formulation of a highly potent and selective PDE4 inhibitor (roflumilast).
  • Individuals with seborrheic dermatitis have lacked new topical treatment options for decades, and current therapies leave much to be desired.
  • We are pleased to have completed enrollment in our pivotal Phase 3 study for roflumilast foam, marking another major milestone for our topical roflumilast clinical program.
  • The STudy of Roflumilast foam Applied Topically for the redUction of seborrheic derMatitis (STRATUM) is a Phase 3, parallel group, double blind, vehicle-controlled study of the safety and efficacy of roflumilast 0.3% foam administered once-daily.

FDA Accepts Arcutis Biotherapeutics’ New Drug Application for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

Retrieved on: 
Wednesday, December 22, 2021
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The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022.

Key Points: 
  • The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2022.
  • 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.
  • Roflumilast cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor, roflumilast.
  • The companys lead program, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis.