Bristol-Myers Squibb Company BMY announced results from a phase II study on BMS-986165 in patients with moderate-to-severe plaque psoriasis. BMS-986165 is a novel, oral, selective TYK2 inhibitor with a unique mechanism of action, distinct from other kinase inhibitors.
In the phase II study, the patients received BMS-986165 in doses of 3 mg every other day (QOD), 3 mg every day (QD), 3 mg twice daily (BID), 6 mg BID , 12 mg QD, or placebo. The primary endpoint was Psoriasis Area and Severity Index (PASI) 75 at Week 12. Key secondary endpoints included PASI 90 and PASI 100 as well as Dermatology Life Quality Index (DLQI), a quality of life measure.
The study showed that efficacy endpoints including greater than or equal to 75% and 90% reduction in PASI 75, PASI 90 were achieved following 12 weeks of treatment with ≥3 mg daily of BMS-986165, with a favorable risk-benefit profile. Efficacy was seen regardless of a patient’s prior exposure to biologic therapy.
These data were published in the New England Journal of Medicine and presented at the 27th European Academy of Dermatology and Venerology (EADV) Congress.
Shares of the company have decreased 1.2% against the industry’s growth of 5.0% year to date.
Currently there are limited numbers of oral therapies available for the treatment of moderate-to-severe psoriasis and the data suggest that BMS-986165 may be a promising oral option to help patients control their psoriasis in future.
The company is also enrolling patients in a phase III POETYK program (Program to evaluate the efficacy and safety of BMS-986165, a selective TYK2 inhibitor). Phase II studies for patients with systemic lupus erythematosus or Crohn's disease are also ongoing.
We remind investors that Bausch Health Companies Inc.’s BHC plaque psoriasis candidate, Duobrii received a Complete Response Letter (CRL) from the FDA for its new drug application (NDA) in June 2018. The CRL was issued due to questions related to pharmacokinetic data. However, the company resubmitted the NDA, which was accepted by the FDA as a Class 2 resubmission with a PDUFA action date of Feb 15, 2019.
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Zacks Rank & Other Stocks to Consider
Bristol-Myers is a Zacks Rank #1 (Strong Buy) stock.
Other top-ranked stocks in the same space are Roche Holding AG RHHBY, and Eli Lilly and Company LLY. While Roche carries a Zacks Rank #1, Lilly sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Lilly’s earnings per share estimates have increased from $5.16 to $5.47 for 2018 and from $5.53 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 23.2% in the past three months.
Roche’s earnings per share estimates have increased from $2.10 to $2.24 for 2018 and from $2.15 to $2.29 for 2019 over the past 60 days. The stock has rallied 15% in the past three months.
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