Eli Lilly and Company
) recently announced positive results from an ongoing 24-week
phase IIb study of baricitinib. Baricitinib is an oral janus
kinase (JAK) inhibitor being developed for the treatment of
patients suffering from moderate-to-severe rheumatoid arthritis
(RA), who had an inadequate response to methotrexate
The 12-week portion of the study revealed that patients on
baricitinib showed significant differences in ACR20, ACR50 and
ACR70 responses when compared to patients on placebo. The 12- to
24-week portion of the study revealed that patients who continued
receiving 2 mg, 4 mg or 8 mg doses of the candidate sustained or
showed improvement in ACR20, ACR50 and ACR70 responses.
Incyte also used Magnetic Resonance Imaging (MRI) technology
in a sub-study (n=154) to observe joint erosion and other markers
of structural changes in and around the joint on baricitinib
Results from this 12-week sub-study showed a statistically
significant improvement in Total Inflammation Score as well as in
the Total Joint Damage Score for both 4 mg and 8 mg doses of
baricitinib compared to placebo. The same effects were maintained
at 24 weeks also.
We note that Incyte did not report any opportunistic
infections or deaths during the study. Incyte also stated that
baricitinib will now be studied in a phase III study for RA
Incyte recently received a milestone payment of $50 million
from its partner Eli Lilly for advancing baricitinib in a phase
III study for the treatment of RA. Incyte has an exclusive
worldwide license, development and commercialization agreement
with Eli Lilly for baricitinib.
The companies have planned four phase III studies. These
studies will be evaluating safety and efficacy of baricitinib
(2mg and 4 mg dosage) in patients suffering from active RA who
are methotrexate-naive, biologic-naive or biologic-experienced.
After completing any of these studies patients will be eligible
for a fifth study.
Although competition is tough in the RA market, with players
Johnson & Johnson
), we believe baricitinib, once launched, will be able to corner
a market share of its own as the patient base is quite large. The
candidate is also being evaluated in patients suffering from
moderate-to-severe psoriasis (phase II).
Currently, we have a Neutral stance on Incyte in the long run.
The stock carries a Zacks #3 Rank (Hold rating) in the short
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