Plaque Psoriasis Drug Trumps the Competition in Phase III Trial
Bristol Myers Squibb announced positive data from POETYK PSO-2, the second Phase III trial of deucravacitinib for moderate to severe plaque psoriasis. The drug was being evaluated against placebo and Amgen’s Otezla (apremilast).
The trial hit both co-primary endpoints compared to placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI 75), which is at least a 75% improvement of baseline PASI, and the static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks, compared to placebo.
The trial also hit multiple key secondary endpoints, including demonstrating that 6 mg deucravacitinib once a day was superior to Otezla in proportion of patients reaching PASI 75 and sPGA 0/1 at Week 16.
Deucravacitinib is a once daily, oral, selective tyrosine kinase 2 (TYK2) inhibitor. The drug is designed to inhibit interleukin (IL)-12, IL-23 and Type 1 interferon (IFN) pathways. It binds to the regulatory domain of TYK2, which is structurally distinct from the Janus kinase (JAK) 1, 2 and 3 kinases.
“I am excited to see that the results from this second pivotal trial further support the promising efficacy and safety profile of deucravacitinib,” said Bruce Strober, Clinical Professor of Dermatology at Yale University School of Medicine and Central Connecticut Dermatology. “This represents an important step for the over 100 million people living with psoriasis worldwide, many of whom remain undertreated and are in need of new, effective oral therapies.”
POETYK PSO-2 is the second of two global Phase III trials. Both demonstrated superiority of deucravacitinib compared to placebo and Otezla for this indication. The data from the first trial, POETYK PSO-1, were announced in November 2020.
Psoriasis is a common chronic, systemic immune-mediated disease. It affects at least 100 million people worldwide. About 90% of patients have psoriasis vulgaris, also called plaque psoriasis, marked by distinct round or oval plaques usually covered by silvery white scales. Psoriasis is linked to multiple comorbidities, including cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, depression and malignancies.
Sami Hirawat, executive vice president, chief medical officer, global drug development, for Bristol Myers Squibb, stated, “The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule. The encouraging data we have seen to date suggest deucravacitinib may become an important oral treatment option for people living with psoriasis. We look forward to discussing the results from the POETYK PSO-1 and POETYK PSO-2 registrational studies with health authorities, with the goal of offering this novel therapy to those suffering from this serious disease as soon as possible.”
Bristol Myers Squibb also announced today that WuXi STA, a subsidiary of WuXi AppTec, had agreed to buy Bristol Myers Squibb’s manufacturing plant in Couvet, Switzerland. It will be WuXi STA’s first facility in Europe. WuXi STA is a Contract Development and Manufacturing Organization (CDMO).
“The Couvet site is a world-class facility designed for quality, safety, and efficiency, and we believe WuXi STA will be able to leverage the capacity and capabilities for its own operations as it continues to play a vital role for patients around the world,” said Lou Schmukler, executive vice president and president, Global Product Development and Supply, Bristol Myers Squibb. “This is an important step in the ongoing evolution of our manufacturing network to support our product portfolio. Switzerland remains an important strategic location for Bristol Myers Squibb, and we look forward to maintaining a strong presence in the Neuchatel area.”