Modified-release Formulation Selected for Clinical Advancement
Translational Pharmacology Data to be Presented at World Pharma Congress
CAMBRIDGE, MA, USA I May 22, 2014 I Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported successful results from a phase 1 clinical study to evaluate multiple modified-release formulations of Z944, a novel, oral, T-type calcium channel modulator in development for the treatment of pain. The open label, randomized cross-over study compared three modified-release tablet formulations of Z944 with the immediate-release capsule formulation which was shown to be effective in a previous human clinical model of pain. The selected tablet formulation demonstrates a superior exposure and tolerability profile and warrants further clinical development.
“This result represents a significant step forward in the development of Z944,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “A tablet formulation with an optimized pharmacokinetic and tolerability profile, together with the successful translation in a human pain model leaves Z944 poised to advance into Phase 2 in an appropriate pain indication.”
In addition, translational pharmacology studies performed in collaboration with Brown University and Rhode Island Hospital have confirmed the central nervous system (CNS) action and pharmacodynamic effects of Z944 using an electroencephalography (EEG) biomarker model. In this model, systemic Z944, at concentrations relevant to those effective in humans, reversed brain changes associated with neuropathic pain by restoring normal brain wave function. Furthermore, normalization of brain wave function by Z944 correlates with attenuation of pain-like behaviors in rodent neuropathic pain models.
“The ability of Z944 to normalize brain signaling dynamics and reverse evoked and spontaneous pain-like behaviors is an exciting finding for the pain field,” commented Carl Y. Saab, PhD, Assistant Professor of Neurosurgery and Neuroscience at Brown University & Rhode Island Hospital. “Our laboratory has demonstrated a strong correlation between chronic neuropathic pain behaviors and altered brain waves, further supporting the potential effectiveness of Z944 in pain.”
Dr. Saab presented data from the translational pharmacology collaboration with Zalicus at the 13th Annual World Pharma Congress: Tackling Translational Challenges in Boston on May 21, 2014.
About Z944 and T-type Calcium Channels
Z944 is a novel, oral, state-dependent, selective T-type calcium channel modulator that has demonstrated efficacy in multiple preclinical pain models and in a Phase 1b experimental model of pain. T-type calcium channels have been recognized as key targets for therapeutic intervention in a broad range of cell functions and have been implicated in pain signaling. Zalicus is planning to advance a modified release formulation of Z944 through further clinical development in an appropriate pain indication.
About Zalicus
Zalicus Inc. (Nasdaq Capital Market: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain and has entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain and oncology. To learn more about Zalicus, please visit www.zalicus.com.
SOURCE: Zalicus
Post Views: 43
Modified-release Formulation Selected for Clinical Advancement
Translational Pharmacology Data to be Presented at World Pharma Congress
CAMBRIDGE, MA, USA I May 22, 2014 I Zalicus Inc. (Nasdaq Capital Market: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today reported successful results from a phase 1 clinical study to evaluate multiple modified-release formulations of Z944, a novel, oral, T-type calcium channel modulator in development for the treatment of pain. The open label, randomized cross-over study compared three modified-release tablet formulations of Z944 with the immediate-release capsule formulation which was shown to be effective in a previous human clinical model of pain. The selected tablet formulation demonstrates a superior exposure and tolerability profile and warrants further clinical development.
“This result represents a significant step forward in the development of Z944,” commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “A tablet formulation with an optimized pharmacokinetic and tolerability profile, together with the successful translation in a human pain model leaves Z944 poised to advance into Phase 2 in an appropriate pain indication.”
In addition, translational pharmacology studies performed in collaboration with Brown University and Rhode Island Hospital have confirmed the central nervous system (CNS) action and pharmacodynamic effects of Z944 using an electroencephalography (EEG) biomarker model. In this model, systemic Z944, at concentrations relevant to those effective in humans, reversed brain changes associated with neuropathic pain by restoring normal brain wave function. Furthermore, normalization of brain wave function by Z944 correlates with attenuation of pain-like behaviors in rodent neuropathic pain models.
“The ability of Z944 to normalize brain signaling dynamics and reverse evoked and spontaneous pain-like behaviors is an exciting finding for the pain field,” commented Carl Y. Saab, PhD, Assistant Professor of Neurosurgery and Neuroscience at Brown University & Rhode Island Hospital. “Our laboratory has demonstrated a strong correlation between chronic neuropathic pain behaviors and altered brain waves, further supporting the potential effectiveness of Z944 in pain.”
Dr. Saab presented data from the translational pharmacology collaboration with Zalicus at the 13th Annual World Pharma Congress: Tackling Translational Challenges in Boston on May 21, 2014.
About Z944 and T-type Calcium Channels
Z944 is a novel, oral, state-dependent, selective T-type calcium channel modulator that has demonstrated efficacy in multiple preclinical pain models and in a Phase 1b experimental model of pain. T-type calcium channels have been recognized as key targets for therapeutic intervention in a broad range of cell functions and have been implicated in pain signaling. Zalicus is planning to advance a modified release formulation of Z944 through further clinical development in an appropriate pain indication.
About Zalicus
Zalicus Inc. (Nasdaq Capital Market: ZLCS) is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain and has entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain and oncology. To learn more about Zalicus, please visit www.zalicus.com.
SOURCE: Zalicus
Post Views: 43
