) announced disappointing initial top-line results from a phase
II study on NKTR-181. The candidate is being developed for the
treatment of moderate-to-severe chronic pain in patients
suffering from osteoarthritis of the knee.
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The phase II, double-blind, placebo-controlled, randomized
withdrawal study evaluated the efficacy, safety and tolerability
of NKTR-181. Patients entering this phase of the study were
randomized equally to either continue to receive NKTR-181 or
Although patients treated with NKTR-181 showed a reduction in
pain scores throughout the randomized phase of the study,
patients under placebo failed to show the expected increase in
pain scores observed in enriched enrolment, randomized withdrawal
studies of similar nature. The company stated in its press
release that the lack of a placebo rebound was unusual. As a
result, the study failed to meet its primary objective.
The primary objective of the study was based on the average
change in pain scores from pre-randomization baseline to the end
of the double-blind, randomized therapy period of the study. The
failure to meet its primary end point is indeed disappointing.
Nektar also intends to review its placebo arm of the study and
will be designing other pivotal trials on the candidate as well.
We remind investors that NKTR-181 currently enjoys fast track
designation in the U.S. for the treatment of moderate-to-severe
We expect the share price of Nektar to be negatively impacted by
the news. We also remind investors that the market for chronic
pain has big companies like
Johnson & Johnson
Nektar presently carries a Zacks Rank #4 (Sell). Stocks such as
) currently look attractive with a Zacks Rank #1 (Strong