Bristol-Myers Squibb’s TYK2 team has been showing off some Phase II data they believe puts them in the running for leader of a small but prominent pack of developers looking to advance a new class of anti-inflammatories that aim at penetrating some very big markets.
As published in the New England Journal of Medicine and presented at the 27th European Academy of Dermatology and Venerology Congress in Paris, Bristol-Myers’ effort for BMS-986165 produced some competitive results in a key mid-stage study for moderate-to-severe plaque psoriasis — a packed field where JAK inhibitors have been making waves.
By narrowly targeting TYK2 — and leaving the other JAK family targets out — with an allosteric approach, as opposed to ATP binding, the Bristol-Myers group say they were able to safely produce a range of competitive PASI75 clearance rates of 67% to 75% for the three highest doses of the oral drug in the dose-ranging study.
“From my perspective the clinical data we have bears out the strategy we set out to deliver right in the early stages of the discovery program,” says John Throup, the development lead for TYK2, who offered a preview of the data that was on display Wednesday, along with discovery chemist Ryan Moslin.
This was an in-house program from the very beginning at Bristol-Myers. And they’re taking it all the way through, looking to trip up pro-inflammatory cytokine receptors, including the hot target IL-23, IL-12 and Type 1 interferons with what they believe is a clearly safe oral drug looking to distinguish itself from a very big — and growing — field of rivals.
The drug is already in two Phase III studies for psoriasis, which jointly recruited 1,600 patients with a planned read-out in mid-2020. And they’re expanding the work into Crohn’s and lupus, keeping an eye on other targets they could add as well
“Patients don’t need another non-specific JAK inhibitor,” adds Throup, noting the safety issues that have come up for the class, which includes baricitinib and Xeljanz. And they believe that they’ve also taken the right path in the clinic by avoiding the active binding site and targeting the regulatory domain in TYK2.
Of course, this drug still has to survive the big Phase III challenge in much larger patient populations that are designed to spotlight any small safety issue. And rival development groups focused on TYK2 for Celgene and its partners at Nimbus, which is still preclinical, as well as Pfizer — which a spokesperson tells me has mapped four Phase II studies for PF-06700841— aren’t likely to let Bristol-Myers pass unchallenged.
In the meantime, AbbVie is hustling ahead with its regulatory review of the IL-23 drug risankizumab for psoriasis, convinced they have the data needed to field a megablockbuster. And there are more injectables like Cosentyx — and filgotinib from Gilead and Galapagos — which is already well established.
Bringing a safe, effective oral drug could disrupt that fast-changing marketplace. But this is one battle of the giants where everyone will be fiercely defending their turf.
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