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2021-02-20| R&DTrials & Approvals

Dermavant Sciences’ Psoriasis Drug Promises in Phase 3 Trials

by Tulip Chakraborty
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Psoriasis, a chronic, systemic, inflammatory skin disorder, affects approximately 125 million people globally, with 8 million people in the US alone, and is characterized by red patches and scaly skin. Psoriasis not only has a significant impact on the patient’s quality of life, but it also renders them vulnerable to numerous health conditions, including hypertension, psoriatic arthritis, among others.

Dermavant Sciences, a subsidiary of Roivant Sciences, announced interim positive data for their potential plaque psoriasis candidate tapinarof in PSOARING 3, a subset of their Phase 3 study. The company had bought tapinarof from GlaxoSmithKline in 2018 for $330 million based on promising Phase 1 and 2 results and is keen to get back a return on their investment. This study might help manifest their goal as it comes close on the heels of encouraging results from last year’s PSOARING 1 and PSOARING 2.

Tapinarof is a therapeutic aryl hydrocarbon receptor modulating agent who showed a significant reduction in psoriasis in patients enrolled in PSOARING 1and 2. This led to approximately 90% of the patients enrolling in PSOARING 3, an extension of PSOARING 1 and 2.

Philip Brown, MD, JD, Chief Medical Officer of Dermavant, said, “This interim analysis from PSOARING 3 provides additional support for tapinarof’s previous safety results, exhibited across multiple trials, adding a 52-week observation period to the previous maximum of 12 observed weeks. Importantly, these results appear to be consistent, and we observed no new safety signals in this interim analysis, and no worsening of the underlying safety profile for tapinarof observed in our PSOARING 1 and PSOARING 2 trials”.

Dermavant expects to complete PSOARING 3 by the first half of this year and intends to submit it to the FDA around the middle of the year.

“We are excited to share the results from our interim analysis of PSOARING 3, which represent yet another milestone for Dermavant as we progress towards a mid-2021 NDA submission for tapinarof in adult patients with psoriasis said Todd Zavodnick, Chief Executive Officer of Dermavant.

“We are now focused on compiling a comprehensive NDA submission highlighting the treatment effect, durability on-therapy, remittive effect off-therapy, safety, and tolerability of tapinarof. At the same time, we are furthering our commercial readiness in anticipation of tapinarof’s potential approval and advancing the other assets in our development pipeline.” [1]

 

PSOARING 3

Three Phase 3 clinical trials, namely PSOARING1, PSOARING 2, and PSOARING 3, look into the safety and efficacy of the drug tapinarof in adult plaque psoriasis. PSOARING1 and PSOARING 2 are identical multi-center trials with the primary endpoint of reaching a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear).

PSOARING 3 is a long-term study for analyzing the safety and efficacy of the tapinarof cream. This long-term study consisted of 40 weeks of treatment and a 4-week follow-up period. Interim analysis from these Phase 3 trials revealed that almost 57% of the patients reached the primary endpoint of PGA score of 0 or 1, with almost 40% of patients achieving completely clear skin by the end of the treatment paradigm.

Further, this trial also demonstrated that the median time required for a two-grade decline after stopping treatment is 115 days, suggesting that the drug has effects on remittance. The long-term safety profile from the PSOARING 3 study looks promising and is consistent with earlier trials.

 

Competitors in the Market

If tapinarof gets approved by the FDA, it is poised to enter a crowded plaque psoriasis market. From Amgen’s Otezla, Abbvie’s Humira, Novartis’s Cosentyx to drug combinations such as Duobrii and Wynzora, the giant biopharmas have a strong grip over the market. Additionally, several other biopharmaceuticals, including Arcutis Biotherapeutics, Bristol Myers Squibb, are sprinting to get their products to the market. If Dermavant plays their cards well and focuses on the rapid commercialization of their product, they might stand a chance of capturing some of the market shares.

Related Article: Bristol Myers Squibb Registers Another Trial Win for its Psoriasis Med

References

  1. https://www.dermavant.com/positive-data-from-psoaring-3-support-long-term-use-of-tapinarof-cream-in-adults-with-plaque-psoriasis-with-durable-on-therapy-and-remittive-off-therapy-benefits/

 

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