- 58.2% of patients who entered the study with a PGA score ≥2 achieved a PGA score of 0 or 1-
- Long-term use of tapinarof cream provided improved and durable effects for up to 52 weeks and demonstrated a remittive effect with a median duration of four months for patients entering with a PGA score of 0 -
- Tapinarof cream was well tolerated consistent with the previously reported interim analysis -
September 30, 2021 09:45 AM Eastern Daylight Time
LONG BEACH, Calif., & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced final results from the Phase 3 PSOARING 3 long-term extension study of its investigational product tapinarof, a 1% once daily, non-steroidal topical cream for the treatment of plaque psoriasis in adults. The study results demonstrated that tapinarof cream was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. In addition, in the study tapinarof demonstrated a high rate of complete disease clearance, a median remittive effect off-therapy for approximately four months for patients entering with a PGA score of 0, durability of response for up to 52 weeks, and consistent efficacy regardless of intermittent treatment based on PGA response during the study. The data were presented during a Late-Breaking Session at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
“As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.”
“For the millions of people living with plaque psoriasis, the chronic nature of the condition has both physical and emotional impacts, leaving many looking for additional treatment options,” said Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, and lead investigator for the PSOARING 3 study. “These consistent PSOARING 3 safety and efficacy results suggest that, subject to FDA approval, tapinarof could be an important new topical treatment option for this debilitating condition.”
Eligible patients completing PSOARING 1 or 2, which were 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3, which comprised an additional 40 weeks of open-label treatment followed by a 4-week follow-up. Subjects who received tapinarof treatment during PSOARING 1 or 2 and completed PSOARING 3 received treatment for up to 52 weeks. PSOARING 3, which enrolled 763 patients, was designed to assess the safety and real-world use of tapinarof, and included prespecified analyses of duration of remittive effect off-therapy (defined as off-therapy maintenance of a PGA score of 0 or 1) and durability of response on-therapy. Outcomes were based on Physician Global Assessment (PGA) scores. Results from a planned interim analysis of data from PSOARING 3 were previously announced in February 2021.
Efficacy Data
58.2% (302/519) of patients who entered the PSOARING 3 study with a PGA score ≥2 achieved a PGA score of 0 or 1, demonstrating tapinarof's continued improvement in efficacy beyond the 12-week pivotal studies.
40.9% (312/763) of all patients achieved complete disease clearance (PGA score of 0).
Remittive effect, which was defined as off-therapy maintenance of a PGA score of 0 or 1, was observed in the study:
Median duration of remittive effect off-therapy was 115 days (approximately 4 months) for patients entering the study with a PGA score of 0 (n=79).
Among patients entering the study with or achieving a PGA score of 0 (n=312), the mean duration of remittive effect off-therapy was 130 days.
Durability of response, which was defined as no tachyphylaxis over time, was demonstrated for up to 52 weeks.
“With a high rate of complete disease clearance, a 4-month median remittive effect for patients entering with a PGA score of 0, and durable response with long-term use demonstrated in the PSOARING 3 study, the data for tapinarof continues to impress me over time,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, and PSOARING 3 study investigator. “As a clinician, I am excited about these final results from PSOARING 3 and the potential for tapinarof to be a new therapy for patients suffering from plaque psoriasis.”
Safety Data
Treatment-emergent adverse events (TEAEs) were consistent with those from the interim analysis of data from PSOARING 3 and from the PSOARING 1 and 2 trials, with no new safety signals observed with long-term use.
TEAEs were mostly mild to moderate, at application sites, and associated with a low discontinuation rate (5.4%).
Incidence and severity of folliculitis and contact dermatitis remained stable with long-term use and were associated with low discontinuation rates (1.2% and 1.4%, respectively).
Results from the interim analysis of PSOARING 3, along with results from the previously reported Phase 3 PSOARING 1 and PSOARING 2 trials, served as the basis for the New Drug Application that Dermavant submitted to the U.S. Food and Drug Administration (FDA) in May 2021. The FDA accepted the application and assigned a Prescription Drug User Fee Act target action date in Q2 2022.
“We are excited to offer a more detailed picture at EADV of the long-term efficacy and safety profile of tapinarof in PSOARING 3,” said Philip M. Brown, MD, J.D., Chief Medical Officer of Dermavant. “We look forward to engaging with the FDA on our NDA in due course, as we work to bring tapinarof to plaque psoriasis patients as expeditiously as possible.”
About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis
Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.
PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.
PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and completed PSOARING 3 received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.
About Psoriasis
Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.
Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.
About Dermavant
Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. 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. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
Contacts
Gilmartin:
Laurence Watts
Managing Director
laurence@gilmartinir.com
619-916-7620
dna Communications:
Angela Salerno-Robin
Senior Vice President, Media Relations, Healthcare
ASalerno-Robin@dna-comms.com
212-445-8219
Recent ROIV News
- Organon to Acquire Dermavant including its Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1% • GlobeNewswire Inc. • 09/18/2024 11:30:00 AM
- Pulmovant presents positive proof-of-concept data from the Phase 1b ATMOS study of Mosliciguat in Pulmonary Hypertension at European Respiratory Society Congress • GlobeNewswire Inc. • 09/10/2024 10:30:00 AM
- Roivant Unveils New Pipeline Program Mosliciguat, A Potential First-In-Class and Best-In-Category Inhaled Once-Daily Soluble Guanylate Cyclase (sGC) Activator • GlobeNewswire Inc. • 09/10/2024 10:30:00 AM
- Roivant Provides Update on Graves’ Disease Development Program • GlobeNewswire Inc. • 09/09/2024 11:00:00 AM
- Roivant Reports Financial Results for the First Quarter Ended June 30, 2024, and Provides Business Update • GlobeNewswire Inc. • 08/08/2024 11:00:00 AM
- Roivant to Report Financial Results for the First Quarter Ended June 30, 2024, and Provide Business Update on Thursday, August 8, 2024 • GlobeNewswire Inc. • 07/25/2024 08:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 01:00:39 AM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 05/30/2024 08:46:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/30/2024 11:45:18 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/30/2024 11:15:23 AM
- Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024, and Provides Business Update • GlobeNewswire Inc. • 05/30/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 01:01:34 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 01:01:33 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2024 01:01:26 AM
- Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024, and Provide Business Update on Thursday, May 30, 2024 • GlobeNewswire Inc. • 05/16/2024 08:05:00 PM
- Roivant Announces Positive NEPTUNE Study Results for Brepocitinib in NIU, as well as Board Authorization for up to $1.5 Billion Share Repurchase Program, Including Repurchase of Entire Sumitomo Pharma Stake for $648 Million • GlobeNewswire Inc. • 04/02/2024 11:00:00 AM
- Roivant Sciences Set to Join S&P MidCap 400; Sunrun to Join S&P SmallCap 600 • PR Newswire (US) • 03/26/2024 10:22:00 PM
- Roivant Reports Financial Results for the Third Quarter Ended December 31, 2023, and Provides Business Update • GlobeNewswire Inc. • 02/13/2024 12:00:00 PM
- Roivant to Report Financial Results for the Third Quarter Ended December 31, 2023, and Provide Business Update on Tuesday, February 13, 2024 • GlobeNewswire Inc. • 01/30/2024 09:05:00 PM
- Roivant Reports Positive Initial Phase 2 Results for Batoclimab in Graves’ Disease • GlobeNewswire Inc. • 12/20/2023 09:30:00 PM
- Roche Completes Acquisition of Telavant from Roivant, Including Rights to Novel TL1A Directed Antibody (RVT-3101) for the Treatment of Inflammatory Bowel Disease • GlobeNewswire Inc. • 12/14/2023 02:00:00 PM
- Roivant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential • GlobeNewswire Inc. • 11/28/2023 12:00:00 PM
- Roivant and Priovant Announce Results from Phase 2 Study of Oral Brepocitinib in Systemic Lupus Erythematosus • GlobeNewswire Inc. • 11/27/2023 01:00:00 PM
- Roivant Reports Financial Results for the Second Quarter Ended September 30, 2023, and Provides Business Update • GlobeNewswire Inc. • 11/13/2023 12:00:00 PM
- Roivant Announces Appointment of Mayukh Sukhatme to Its Board of Directors • GlobeNewswire Inc. • 11/10/2023 01:00:00 PM
Vocodia Enters Medical Alert Industry with Innovative Emergency Response Pendant • VHAI • Oct 25, 2024 8:00 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for Third Quarter 2024 • HYDI • Oct 24, 2024 11:18 AM
VAYK Asserts Goal of Q4 Operationally Profitable and Projects Major 2025 Launch • VAYK • Oct 24, 2024 10:40 AM
CBD Life Sciences Inc. (CBDL) Positioned for Significant Growth Amid Nationwide Marijuana Legalization Push • CBDL • Oct 24, 2024 7:07 AM
ZenaTech, Inc. (NASDAQ: ZENA) Software Company Acquisition • AVXL • Oct 23, 2024 8:03 AM
Forte Minerals to Acquire the Miscanthus Epithermal Gold and Porphyry Copper Prospects in Central Perú with Environmental Drilling Permit (DIA) • CUAU • Oct 23, 2024 7:38 AM