Bristol Myers' Experimental Psoriasis Drug Beats Out Amgen's Otezla in Phase III
Bristol Myers Squibb’s experimental psoriasis drug, deucravacitinib (BMS-986165), beat out Amgen’s Otezla (apremilast) in the POETYK PSO-1 Phase III clinical trial. That was, however, only one of several key secondary endpoints. The drug hit the co-primary endpoints compared to placebo, with more patients achieving Psoriasis Area and Severity Index (PASI) 75 and a static Physician’s Global Assessment (sPGA) score of clear or almost clear after 16 weeks.
“With limited oral therapeutic options available for psoriasis, there remains a significant need for safe and effective therapies,” said April Armstrong, associate dean and professor of dermatology at the University of Southern California. “This makes the positive topline results for deucravacitinib in the POETYK PSO-1 trial exciting for the psoriasis community. These findings indicate deucravacitinib has the potential to be a new treatment option for people living with psoriasis and may provide clinically meaningful improvements with the convenience of oral administration.”
Psoriasis is a common chronic, systemic immune-mediated disease affecting about 100 million people globally. Plaque psoriasis, or psoriasis vulgaris, affects about 90% of patients, marked by distinct, round oval plaques covered by silvery white scales. Psoriasis is associated with multiple conditions that can decrease life expectancy, including cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, depression and malignancies.
POETYK PSO-1 is the first of two global Phase III trials evaluating deucravacitinib compared to placebo and Otezla in moderate to severe plaque psoriasis. In total, 66 patients diagnosed with moderate to severe plaque psoriasis were involved in the study, randomized to receive deucravacitinib, a placebo or Otezla.
Deucravacitinib is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical trials across several immune-mediated diseases. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type 1 IFN, which are cytokines involved in inflammation and immune responses.
In addition to psoriasis, deucravacitinib is being studied in psoriatic arthritis, lupus and inflammatory bowel diseases. It is in four other Phase III trials, POETYK PSO-2, 3, 4 and POETYK PSO-LTE.
Investors were apparently excited with the news, causing Bristol Myers Squibb shares to jump about 3.5%. According to analysts, sales for all treatments of psoriasis drugs are expected to increase by about 9.5% each year to about $24.4 billion by 2023.
Amgen picked up Otezla from Bristol Myers Squibb when Bristol Myers acquired Celgene Corporation in 2019. Bristol Myers was forced to divest the drug during the merger because of competitive issues. Amgen paid $13.4 billion in cash for access to the drug. Otezla is approved in the U.S. for moderate-to-severe plaque psoriasis patients who are candidates for phototherapy or systemic therapy; adults with active psoriatic arthritis; and adults with oral ulcers associated with Behcet’s disease. The drug is approved in more than 50 markets outside the U.S. and has patent protection through at least 2028 in the U.S.
In 2018, Otezla sales were $1.6 billion.
In January 2019, Bristol Myers Squibb announced plans to acquire Celgene for about $75 billion. The first snag was when one of its biggest shareholders, Wellington Management Company, objected to the deal. Wellington owned about 8% of Bristol Myers. A few other major shareholders, including Starboard Value and Dodge & Co. also opposed the deal, which obviously, went through anyway.
But when the deal was reviewed by the U.S. Federal Trade Commission (FTC), Bristol Myers was forced to sell off Otezla.
FTCWatch wrote in June 2019, “The merger is expected to face a standard antitrust analysis that examines competition on a drug-by-drug basis but shouldn’t pose a major threat. In the aftermath of the shutdown (U.S. government shutdown), the agency may have gotten a slower start than usual on that review…. The FTC may investigate and find that even on drugs that appear to overlap, there is sufficient competition in the space, or divestiture is possible.”