Phosphodiesterase-4 inhibitor

Arcutis Announces First Patient Enrolled in Phase 3 Clinical Trial of Topical Roflumilast Foam (ARQ-154) as a Potential Treatment for Seborrheic Dermatitis

Retrieved on: 
Monday, July 12, 2021

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 seborrheic dermatitis and scalp 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 seborrheic dermatitis and scalp psoriasis.
  • In our Phase 2 trial, roflumilast foam was demonstrated to be an effective, safe, and well-tolerated treatment for seborrheic dermatitis.
  • We are now pleased to initiate this single Phase 3 pivotal trial, as we believe roflumilast foam, if approved, has the potential to become a much-needed new standard of care for people with seborrheic dermatitis.
  • 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 to Participate at the 6th World Psoriasis & Psoriatic Arthritis Conference with Poster Presentation on HPP737

Retrieved on: 
Tuesday, June 29, 2021

The poster will be added to vTvs website following the presentation and will be available at: https://vtvtherapeutics.com/pipeline/hpp737/ .

Key Points: 
  • The poster will be added to vTvs website following the presentation and will be available at: https://vtvtherapeutics.com/pipeline/hpp737/ .
  • HPP737 is a novel, potent, orally administered PDE4 inhibitor discovered by vTv Therapeutics.
  • PDE4 is a validated therapeutic target for the treatment of a variety of disorders including psoriasis.
  • vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes (T1D) and psoriasis.

FDA Accepts Amgen's Supplemental New Drug Application For Otezla® (apremilast) For Adults With Mild-To-Moderate Plaque Psoriasis

Retrieved on: 
Wednesday, May 5, 2021

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021.\n"Otezla has been prescribed to hundreds of thousands of patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021.\n"Otezla has been prescribed to hundreds of thousands of patients with moderate-to-severe plaque psoriasis.
  • The study randomized 595 patients 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks.
  • PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators.
  • Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506).

Arcutis to Present New Roflumilast Cream Phase 3 Data at The European Academy of Dermatology and Venereology (EADV) Spring Symposium

Retrieved on: 
Monday, May 3, 2021

\xe2\x80\x9cWe are thrilled the pivotal phase 3 data for roflumilast cream in the treatment of chronic plaque psoriasis has been accepted in the program as an oral presentation and look forward to sharing the findings with the dermatology community.

Key Points: 
  • \xe2\x80\x9cWe are thrilled the pivotal phase 3 data for roflumilast cream in the treatment of chronic plaque psoriasis has been accepted in the program as an oral presentation and look forward to sharing the findings with the dermatology community.
  • Join the conversation with the hashtag #EADVSymposium.\nPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States.
  • It can also be associated with hair loss.\nRoflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast).
  • We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.\n'

Arcutis Biotherapeutics to Present New Roflumilast Data at The American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX)

Retrieved on: 
Monday, April 19, 2021

\xe2\x80\x9cWe are pleased to share these new data that further reinforce the potential of roflumilast cream and foam in various inflammatory skin diseases.

Key Points: 
  • \xe2\x80\x9cWe are pleased to share these new data that further reinforce the potential of roflumilast cream and foam in various inflammatory skin diseases.
  • Arcutis is investigating roflumilast as a once-daily, nonsteroidal, topical treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis.\nFor more information, visit https://www.arcutis.com or follow the company on LinkedIn and Twitter .
  • Join the conversation with the hashtag #AADVMX2021.\nPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States.
  • Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors for dermatology.

Arcutis Biotherapeutics to Showcase Long-term Safety, Efficacy, and Patient-Reported Outcomes of Roflumilast Cream for Chronic Plaque Psoriasis at Innovations in Dermatology: Virtual Spring Conference 2021

Retrieved on: 
Wednesday, March 17, 2021

A poster presentation will feature new long-term efficacy and safety data on topical roflumilast 0.3% cream at 52- to 64-weeks (Dr. Linda Stein Gold).

Key Points: 
  • A poster presentation will feature new long-term efficacy and safety data on topical roflumilast 0.3% cream at 52- to 64-weeks (Dr. Linda Stein Gold).
  • Arcutis is investigating roflumilast as a once-daily, nonsteroidal treatment for plaque psoriasis, atopic dermatitis, seborrheic dermatitis, and scalp psoriasis.
  • Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).
  • Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast).

vTv Therapeutics Announces Initiation of Multiple Ascending Dose Study of HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

Retrieved on: 
Wednesday, February 17, 2021

This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate up to 3 doses of HPP737 administered for 14 days in healthy volunteers.

Key Points: 
  • This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate up to 3 doses of HPP737 administered for 14 days in healthy volunteers.
  • The goal of this study is to determine the maximum tolerated dose with minimal or no gastrointestinal intolerance to inform dose selection for a phase 2 study in psoriasis which is planned for later this year.
  • HPP737 is a novel, potent, orally administered PDE4 inhibitor discovered by vTv Therapeutics.
  • PDE4 has been demonstrated to be a validated therapeutic target for the treatment of a variety of disorders including psoriasis.

Arcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis

Retrieved on: 
Monday, February 1, 2021

(Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced positive topline results from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream ( ARQ-151 ) as a potential topical treatment for plaque psoriasis .

Key Points: 
  • (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced positive topline results from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream ( ARQ-151 ) as a potential topical treatment for plaque psoriasis .
  • Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).
  • Overall, 90% of patients who were randomized to roflumilast cream in the studies completed the full 8 weeks.
  • Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast).

Arcutis to Advance Topical Roflumilast Foam (ARQ-154) into Phase 3 Development for the Treatment of Seborrheic Dermatitis

Retrieved on: 
Wednesday, January 20, 2021

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

Key Points: 
  • Roflumilast foam is a once-daily topical foam formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor.
  • Following our interactions with the FDA, we are delighted to advance topical roflumilast foam into Phase 3 development for the treatment of seborrheic dermatitis, a disease that affects more than 10 million people in the U.S., said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis Chief Medical Officer .
  • If successful in the Phase 3 clinical trial and approved for commercialization, roflumilast foam has the potential to become the standard of care in seborrheic dermatitis.
  • Arcutis believes roflumilast foam has significant potential as a treatment for seborrheic dermatitis.

Arcutis Initiates Pivotal Phase 3 Clinical Trials Evaluating Topical Roflumilast Cream (ARQ-151) as a Potential Treatment for Atopic Dermatitis

Retrieved on: 
Wednesday, January 13, 2021

(Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream ( ARQ-151 ) as a potential treatment for atopic dermatitis (AD).

Key Points: 
  • (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced that it has commenced pivotal Phase 3 clinical trials evaluating topical roflumilast cream ( ARQ-151 ) as a potential treatment for atopic dermatitis (AD).
  • Dr. Burnett continued, We are excited to begin our pivotal Phase 3 trials in patients with atopic dermatitis.
  • If approved, roflumilast cream would be the first once-a-day topical nonsteroidal treatment for AD, and would also offer patients a cosmetically-elegant, non-greasy formulation.
  • Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast).