Efficacy Signals in Inflammatory and Neuropathic Pain Observed
Second U.S. Patent Issues for Z944 Providing Exclusivity to 2029
Statistically significant and meaningful reductions at each of the
three doses compared to placebo of overall peak-to-peak (PtP)
amplitude of LEPs in models of both inflammatory (p=0.0002) and
neuropathic (p<0.05) pain.
Consistent trends in reduction of subjective pain scores compared to
placebo using a visual analog scale in both pain models.
Meaningful trends in effects based on dose and concentration,
providing important insights into the potential therapeutic window and
effective plasma concentrations of Z944.
Z944 was generally well tolerated with dose dependent CNS side effects
and no serious adverse events.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from
pain, today announced positive results of a Phase 1b clinical study with
Z944, a novel oral T-type calcium channel modulator in development for
the treatment of pain. The Phase 1b study is an experimental clinical
model utilizing Laser-Evoked-Potentials (LEP) to provide both objective
and subjective assessments of the activity of Z944 in induced pain
states. Based on these results, Zalicus is planning to advance a
modified-release formulation of Z944 into Phase 2 clinical development
in an appropriate pain indication in 2014. In addition, a second United
States patent for Z944 (U.S. Patent number 8,569,344) covering methods
of treating pain was issued on October 29, 2013, providing additional
patent protection for Z944 in the United States until at least 2029.
“This is the first T-type calcium channel modulator to demonstrate
clinical translation in pain, and these results are indicative of Z944’s
potential activity in modulating pain signaling. We look forward to
further evaluating a modified release formulation of Z944 in a relevant
clinical pain syndrome in 2014,” commented Mark H.N. Corrigan, MD,
President and CEO of Zalicus.
This exploratory, double-blind placebo-controlled, randomized
cross-over, Phase 1b clinical study enrolled 16 healthy volunteers and
was conducted in a single center in Germany. The primary objective of
the study was to compare the analgesic/anti-hyperalgesic properties of
three different single doses of Z944 in a model of inflammatory pain and
in a model of chronic neuropathic pain as compared with placebo.
Highlights of the results of the Z944 Phase 1b LEP study results include: