Takeda Pharmaceutical Co.’s newly purchased oral psoriasis drug was safe and effective in a mid-stage study, highlighting its potential for treating the painful, incurable skin condition.
(Bloomberg) — Takeda Pharmaceutical Co.’s newly purchased oral psoriasis drug was safe and effective in a mid-stage study, highlighting its potential for treating the painful, incurable skin condition.
Patients with moderate-to-severe plaque psoriasis who received TAK-279 had significantly clearer skin after three months than those given placebo, according to the study presented Saturday at the American Academy of Dermatology’s annual meeting. Skin damage from the disease cleared completely in one-third of those getting the highest dose, the Japanese drugmaker said in a statement.
More than 125 million people worldwide have the skin disease, with plaque psoriasis the most common form. Once dominated by topical ointments and infused antibodies, the psoriasis market has grown along with the introduction of drugs like Bristol-Myers Squibb Co.’s Sotyktu – launched last year – and Amgen Inc.’s Otezla. It’s projected to double to $55.8 billion by 2031, according to Allied Market Research.
Takeda bought TAK-279 last month for $4 billion, plus potential milestone payments worth another $2 billion, from Boston-based Nimbus Therapeutics LLC. It’s one of several medicines Takeda is developing to buffer an expected sales decline in the coming years when its best-selling drug Entyvio for ulcerative colitis faces generic competition.
The drug, one of just a few comparable oral psoriasis treatments, was designed and optimized using a molecular simulation model, according to Andrew Plump, Takeda’s president of research and development, and has already demonstrated a high level of effectiveness. Takeda is planning a head-to-head trial against Sotyktu, which also blocks an inflammatory protein call TYK2 to fight the skin disease.
“We think we have a best-in-class drug, the best oral agent that will be available,” he said in an interview. Among the advantages of Takeda’s candidate is its safety at high doses, which contributes to its effectiveness, he said. “It’s a very well-behaved molecule.”
Takeda is expecting to have two full final-stage studies enrolled later this year, Plump said. Studies in other potential uses of the drug, such as psoriatic arthritis, lupus, Crohn’s disease and ulcerative colitis, will follow, he said.
The drug could generate $5 billion in peak sales, particularly if it’s successful in treating conditions including inflammatory bowel disease, said Stephen Barker, an analyst at Jefferies, in a note to clients.
In the study, 259 patients were given one of four different doses of the pills or a placebo for 12 weeks. More than two-thirds of those who received the highest doses once daily had a 75% or greater improvement in their skin. Patients getting lowest doses didn’t benefit as much.
Patients getting the drug were more likely to have side effects than those who received a placebo. Most were mild-to-moderate in severity and didn’t lead patients to discontinue treatment. Two serious adverse events occurred in one patient getting the 15 mg dose but were considered unrelated to treatment, the company said.
Psoriasis causes a rash with itchy, scaly patches, often on the knees, elbows, trunk and scalp, according to the Mayo Clinic. It’s thought to be an immune system problem where infection-fighting cells inexplicably attack healthy skin cells. Treatments help manage symptoms but there’s no cure.
–With assistance from John Lauerman.
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