Global Assessment of Functioning

Dermavant Announces Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Plaque Psoriasis in the Head and Neck Region in Adults

Retrieved on: 
Wednesday, December 6, 2023

“Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body.

Key Points: 
  • “Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body.
  • DMVT-505-4002 (NCT05789576) was a Phase 4, open-label multi-center study to investigate the efficacy and safety of VTAMA (tapinarof) cream, 1% for the treatment of adults with plaque psoriasis specifically in the head and neck region.
  • The trial enrolled 31 participants with mild, moderate, and severe head and neck plaque psoriasis (tPGA score ≥2) aged 18 years or older at 8 sites across the U.S.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Dermavant Presents Positive Results from Phase 4 Open-Label Trial of VTAMA® (tapinarof) Cream, 1% for the Treatment of Intertriginous Plaque Psoriasis in Adults at 43rd Annual Fall Clinical Dermatology Conference

Retrieved on: 
Friday, October 20, 2023

Intertriginous plaque psoriasis, also known as inverse psoriasis, affects approximately 20%–30% of individuals who have plaque psoriasis.

Key Points: 
  • Intertriginous plaque psoriasis, also known as inverse psoriasis, affects approximately 20%–30% of individuals who have plaque psoriasis.
  • The treatment for plaque psoriasis in intertriginous areas is specifically challenging, because these sensitive areas are more prone to potential adverse effects from existing steroidal-topical treatments.
  • DMVT-505-4001 (NCT05680740) was a Phase 4, open-label multi-center study that evaluated the efficacy and safety of VTAMA (tapinarof) cream, 1% in adults with intertriginous plaque psoriasis (iPsO).
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Worldwide Market for Life Science Instrumentation to 2026: Market Opportunities, Expected Growth and Important Trends - ResearchAndMarkets.com

Retrieved on: 
Friday, January 20, 2023

The "The Worldwide Market for Life Science Instrumentation, 2021-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "The Worldwide Market for Life Science Instrumentation, 2021-2026" report has been added to ResearchAndMarkets.com's offering.
  • The Worldwide Market for Life Science Instrumentation, 2021- 2026 is designed to provide total market knowledge for every significant life science instrumentation category.
  • This comprehensive report details the market opportunity expected growth and important trends in these essential instruments for manufacturing, control, research and development of biopharmaceutical therapies, as well as instruments used for basic life science research.
  • This section is directly extracted from the Global Assessment Report: The Analytical and Life Science Instrumentation Industry.

VTAMA® (tapinarof) Cream, 1% PSOARING 3 Final Data Published in JAAD

Retrieved on: 
Tuesday, June 28, 2022

VTAMA Creams demonstrated combination of efficacy, remittive effect, durability and tolerability make it a strong addition to the psoriasis armamentarium.

Key Points: 
  • VTAMA Creams demonstrated combination of efficacy, remittive effect, durability and tolerability make it a strong addition to the psoriasis armamentarium.
  • Newly published final data in JAAD includes efficacy outcomes, quality of life, safety, and tolerability assessments observed over long-term use of VTAMA (tapinarof) Cream, 1%.
  • The PSOARING 3 LTE study forms part of Dermavants pivotal Phase 3 plaque psoriasis clinical program for VTAMA Cream.
  • On May 24, Dermavant announced that the FDA had approved VTAMA (tapinarof) Cream, 1% for the treatment of adult plaque psoriasis.

FDA Approves Dermavant’s VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years

Retrieved on: 
Tuesday, May 24, 2022

Dermavant is prepared for a June 2022 launch with product and sample manufacturing runs completed and a fully staffed commercial team.

Key Points: 
  • Dermavant is prepared for a June 2022 launch with product and sample manufacturing runs completed and a fully staffed commercial team.
  • This approval makes VTAMA cream the first and only FDA-approved steroid-free topical medication in its class.
  • Indication: VTAMA (tapinarof) Cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.
  • Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80 to 90% of people with psoriasis.

Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022

The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging.

Key Points: 
  • The durable improvements demonstrated by tapinarof in PSOARING 3 across efficacy outcomes, quality of life and tolerability scores are encouraging.
  • As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.
  • Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

Dermavant Showcases New Long-Term Durability and Tolerability Data from Phase 3 PSOARING 3 Trial of Tapinarof Cream for Adults with Plaque Psoriasis at the 2022 AAD Annual Meeting

Retrieved on: 
Friday, March 25, 2022

As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.

Key Points: 
  • As a clinician, I am excited about the possibility of a potential new therapy in tapinarof for patients suffering from plaque psoriasis.
  • Eligible patients who completed either PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3.
  • Patients who were randomized to tapinarof in PSOARING 1 or 2 and who also completed PSOARING 3 received tapinarof treatment for up to 52 weeks.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis.

InflaRx Announces Positive Data from Third Cohort of Phase IIa Open-Label Study with Vilobelimab in Pyoderma Gangraenosum

Retrieved on: 
Wednesday, October 27, 2021

JENA, Germany, Oct. 27, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG).

Key Points: 
  • JENA, Germany, Oct. 27, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangraenosum (PG).
  • We are happy to see more patients responding with the highest dose of vilobelimab in patients with Pyoderma Gangraenosum, commented Dr. Korinna Pilz, Chief Clinical Development Officer of InflaRx.
  • As previously announced, a total of 19 patients were enrolled in the multi-center, proof-of-concept study, with seven patients enrolled in the third cohort.
  • The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG.

Dermavant Showcases New Long-Term Data from Phase 3 PSOARING 3 Trial of Tapinarof in Patients with Plaque Psoriasis at the 30th EADV Virtual Congress

Retrieved on: 
Thursday, September 30, 2021

The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.

Key Points: 
  • The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
  • Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks.
  • Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3.
  • The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis, and has initiated a Phase 3 program in atopic dermatitis in patients aged 2 years and older.

InflaRx Announces Positive Data from Second Interim Analysis of Ongoing Phase IIa Open Label Study with Vilobelimab in Pyoderma Gangraenosum

Retrieved on: 
Tuesday, August 10, 2021

JENA, Germany, Aug. 10, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).

Key Points: 
  • JENA, Germany, Aug. 10, 2021 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the first 10 evaluable patients in the ongoing Phase IIa open label study with vilobelimab in Pyoderma Gangraenosum (PG).
  • As previously announced, enrollment in the proof-of-concept study was completed with 19 patients, with 12 in the first two dose cohorts.
  • The main objectives of the study are the evaluation of the safety and efficacy of vilobelimab in patients with PG.
  • Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases.