- An experimental psoriasis drug developed by Bristol Myers Squibb outperformed Amgen's approved treatment Otezla in a late-stage study, according to summary results disclosed by Bristol Myers on Tuesday, sending shares in the New York pharmaceutical company higher.
- Treatment with a once daily 6 milligram dose of Bristol Myers drug, dubbed deucravacitinib, led to substantially clearer skin in more psoriasis patients than did either placebo or Otezla. Both deucravacitinib and Otezla are taken orally, an advantage in a market mostly made up of injectable medicines.
- While more detailed data are needed, the trial's outcome likely signals future competition for Otezla, which Celgene was forced to sell last year to win regulators' approval for its acquisition by Bristol Myers. A second trial, also comparing deucravacitinib to placebo and Otezla, is due to return results by early next year.
Approved, on-market drugs for prevalent diseases aren't often put up for sale, as Otezla was last year. Amgen jumped at the opportunity, paying Celgene $13.4 billion for rights to the medicine in its largest deal since a 2009 acquisition of Immunex.
But, if Bristol Myers' results hold up under further scrutiny, Amgen's new drug may be under pressure in just a few years.
In the trial, which enrolled 666 people with moderate-to-severe psoriasis, Bristol Myers compared treatment with deucravacitinib against placebo and Otezla on two commonly used measures of disease severity. After four months, deucravacitinib was found to be superior to both placebo and Otezla on the two scores, known as PASI and sPGA.
Detailed results will be shared at an upcoming medical meeting, Bristol Myers said. Without those data, previous mid-stage results for deucravacitinib provide a rough gauge of what responses to the drug could look like.
The Phase 2 study, published in September 2018, showed Bristol Myers' drug led to a 75% or greater reduction in PASI scores by week 12 in two thirds of patients given an equivalent 6 milligram-per-day dose. Otezla, by comparison, led to similar reductions in 29% to 33% of patients treated in the two trials supporting the drug's approval.
"The key thing about [Bristol Myers]'s drug is that its oral [dosing] achieves PASI-75 scores in line with the injectables, like Humira," wrote Mizuho Securites USA analyst Salim Syed, referencing AbbVie's top-selling anti-inflammatory drug in a Nov. 3 note to clients.
Humira, and drugs like it, are widely used across a range of autoimmune conditions, including rheumatoid arthritis as well as as psoriasis. An oral drug with similar effectiveness could be quickly adopted, Wall Street analysts believe.
Raymond James, for instance, models peak sales for deucravacitinib at $2 billion by 2027.
One remaining question mark is deucravacitinib's safety. Bristol Myers said side effects to treatment looked similar to what was observed in the mid-stage trial, which showed the drug led to cold symptoms, headaches and itching in a small percentage of study participants.
"Deucravacitinib treatment has appeared rather safe, however there were a handful of serious adverse events in the active arm in the Phase 2 and safety data from the Phase 3 are quite limited," wrote Brian Skorney, an analyst at R.W. Baird, in an Nov. 3 note to clients.
In particular, the Food and Drug Administration could view deucravacitinib as working similarly to a class of oral drugs known as Janus kinase inhibitors, which are being tested in several autoimmune diseases and have been closely scrutinized for potentially worrisome side effects.
Deucravacitinib is also a kinase inhibitor, but blocks a kinase called TYK2, which is involved in intracellular signalling to proteins involved in inflammatory and immune responses. Bristol is exploring its use in several autoimmune conditions, among them psoriatic arthritis, lupus and inflammatory bowel disease.
While deucravacitinib is more advanced, Bristol Myers is developing another TYK2 inhibitor and owns an exclusive option to license or acquire a TYK2 inhibitor from Nimbus Therapeutics — a deal it inherited by buying Celgene.
Nimbus recently raised $60 million in funding from RA Capital Management and BVF Partners to speed its TYK2-blocking drug into Phase 2 testing next year.
Pfizer is also testing a TYK2 inhibitor in Phase 2 clinical trials.
Sales of Otezla totaled $1.58 billion through the first nine months of 2020, according to financial results reported by Amgen in late October.