Positive Data on Incyte/LLY's Baricitinib

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Incyte Corporation (INCY) and partner Eli Lilly and Company (LLY) recently announced positive results from the open-label, long-term extension of the phase IIb JADA study on their pipeline candidate, baricitinib.

Baricitinib (formerly LY3009104) is being developed for the treatment of patients suffering from certain autoimmune conditions, including rheumatoid arthritis (:RA). The study evaluated the efficacy and safety of baricitinib in the patients for up to 52 weeks across to two doses (4 mg and 8 mg).

Incyte and Eli Lilly earlier reported encouraging data from the 12-week portion of the study. Results from the 12-week study revealed that patients on baricitinib showed significant improvements in in ACR20, ACR50 and ACR70 responses when compared to patients on placebo. Incyte also stated that these improvements were either sustained or improved during an additional 12 weeks of blinded treatment.

Moreover, the clinical improvements observed at week 24 were maintained through 52 weeks in RA patients. For example, 74% patients treated with baricitinib achieved at least 20% reduction in the disease symptoms at 24 weeks and 71% achieved similar response at 52 weeks. The measure is known as American College of Rheumatology (:ACR) 20.  ACR50 and ACR70 scores were also found to be comparable at 24-weeks and 52 weeks of treatment by the candidate.

The open-label extension study also revealed that safety signals like treatment-emergent adverse events, serious adverse events, infections and serious infections remained consistent with the previous studies of baricitinib. Meanwhile, the 8 mg group of the study reported a death due to a suspected myocardial infarction. We note that out of the 201 patients, 184 completed 52-weeks of therapy in the study. The JADA study is still continuing with patients receiving with only the 4 mg version of the candidate.

However, competition is stiff in the RA market given the presence of treatments like AbbVie Inc.’s(ABBV) Humira among others.

Incyte and Eli Lilly are also developing baricitinib for the treatment of psoriasis and diabetic nephropathy.

Incyte, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Another biopharma stock, Jazz Pharmaceuticals Public Limited Company (JAZZ), currently looks better positioned with a Zacks Rank #1 (Strong Buy).

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