AlzeCure gets late-breaking abstract on ACD440 in neuropathic pain accepted for presentation
April 27, 2021
AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of drug candidates for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that it has received approval to present an abstract on its lead candidate drug ACD440 for neuropathic pain at the IASP 2021 World Congress on Pain, which this year will be held completely digitally on June 9-11 and June 16-18.
The late-breaking abstract, titled ACD440 – A potent TRPV1 Antagonist for the topical Treatment of Pain, will be presented at the biggest global pain conference IASP 2021 World Congress on Pain by Dr. Märta Segerdahl, project leader and CMO at AlzeCure. The other authors include Dr. Klaus Schaffler, who conducted the Proof-of-Mechanism study of ACD440, Dr. Johan Sandin, CSO at AlzeCure, and Matthias Rother, Medical Program Director at AlzeCure.
On April 19, slightly ahead of time, AlzeCure announced positive clinical data from the study, which demonstrate that ACD440, a TRPV1 antagonist and AlzeCure’s drug candidate for neuropathic pain within the company’s Painless platform, was able to demonstrate positive proof-of-mechanism data, showing analgesic efficacy in man. The observed effects with ACD440 were highly significant over placebo. Also, it was well tolerated as a topical gel on human skin which indicates good suitability for further clinical development, i.e. as a local treatment for neuropathic pain conditions.
“I am very pleased that we once again receive an approval for an abstract with one of our leading candidate drugs, this time from our Painless platform. This is a clear validation of our clinical development platform and strengthens our conviction that we are right in our research and our projects. The new data we have for ACD 440 in neuropatic pain are promising, and we look forward to present it”, said Martin Jönsson, CEO of AlzeCure Pharma AB.
Dr. med. Schaffler was a invited Speaker at NIH Workshop on the topic Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain
Session: Emerging Tools and Approaches in Biomarker Discovery and Development
Title: Predictive validity of human Laser-EPs in extended phase-I IND analgesic research
FIRST CLINICAL TRANSLATION OF THE ANTI-NOCICEPTIVE/ANTI-HYPERALGESIC EFFICACY OF A T-TYPE CALCIUM CHANNEL MODULATOR (Z944) – USING LASER EVOKED POTENTIALS AND VAS IN UV-B AND CAPSAICIN IRRITATED SKIN IN HEALTHY HUMANS
Author Block: K. D. Schaffler Germany,Head, HPR-Human Pharmacodynamic Res., Munich; M. S. Lee, Res. & Translational Med., Zalicus Pharmaceuticals Ltd., Cambridge, MA, USA; M. Versavel, Zalicus Pharmaceuticals
HPR Dr. Schaffler GmbH in cooperation with Zalicus announces positive results of Z944 Phase 1B Clinical Study in Pain
Positive results of Z944 Phase 1B Clinical Study in Pain
Efficacy Signals in Inflammatory and Neuropathic Pain Observed
Second U.S. Patent Issues for Z944 Providing Exclusivity to 2029
Munich, Germany – June 17th, 2014 – HPR Dr. Schaffler GmbH, a contract research organization, which conducts Phase 1 clinical trials in the field of CNS pain research, announced positive results of a Phase 1b clinical study for its customer Zalicus (Z944). Research object is 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:
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.
In this study, hypersensitivity to laser thermal stimulation was induced by UV light exposure as a model of inflammatory pain and by topical capsaicin as a model of neuropathic pain. Electrical voltage fluctuations evoked by laser thermal stimulation were quantified with vertex-Electroencephalography(EEG) in addition to a subject-reported pain score. Many currently approved and emerging pain drugs have been evaluated using the LEP model, providing the ability to benchmark the efficacy of Z944 against other therapies.
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 inflammatory 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.
Excerpt
Zalicus Announces Positive Results of Z944 Phase 1b Clinical Study in Pain
Efficacy Signals in Inflammatory and Neuropathic Pain Observed
Second U.S. Patent Issues for Z944 Providing Exclusivity to 2029
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zalicus 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.
Wir (Andrea Edginton and Klaus Schaffler) hatten eine Poster-Präsentation (in Zusammenarbeit zwischen der School of Pharmacy, University of Waterloo, Ontario, Kanada und HPR München) im Rahmen des 2012 ASCPT (American Society for Clinical Pharmacology and Therapeutics) Annual Meeting, am 12.-17. März, 2012 in National Harbor, Maryland, USA mit dem folgenden Titel (bitte kontaktieren Sie uns für die Übersendung eines Poster-PDF-Files – sofern gewünscht -oder klicken Sie hier Final Edginton Pain ASCPT 2012 (5)):
Titel: “PAIN PERCEPTION AND PROCESSING IN A MEDICATED STATE:
A PILOT STUDY IN AN ELDERLY COHORT”
Im Rahmen des 13th World Congress on Pain (IASP) in Montreal, Quebec, Canada (Aug./Sept. 2010) – hatten wir eine Posterpräsentation in Zusammenarbeit mit Abbott Laboratories, Chicago, USA – mit dem folgenden Titel (bitte kontaktieren Sie uns, sofern Sie einen PDF-File des Posters zugesandt bekommen wollen – oder klicken Sie einfach hier, um es sich anzusehen Poster_LEP_IASP 2010):
Title: “Effects of a Novel TRPV1 Antagonist ABT-102 in a Human Experimental Pain Study Using Laser Somatosensory Evoked Potentials Obtained from UVB-Irritated and Normal Skin in Healthy Volunteers”
Im Rahmen des siebten EFIC PAIN Kongresses hatten wir eine Poster-Präsentation (am 23. September 2011) in Zusammenarbeit mit Janssen R&D, Beerse, Belgien und Johnson&Johnson, Titusville, USA mit dem folgenden Titel (kontaktieren Sie uns bitte, wenn Sie einen Poster PDF-File zugesandt bekommen wollen oder klicken Sie hier, um es sich anzusehen Poster_LEP_EFIC 2011):
Title: “Dose-response relationship after single oral dose administrations of morphine and oxycodone in a human experimental algesimetric model using laser evoked potentials on UVB‑irradiated skin in healthy male subjects”
Diese akademische Pilot-Studie – in Zusammenarbeit mit der School of Pharmacy der Universität Waterloo, Ontario Kanada – wurde Ende Juli beendet. Die komplette statistische Auswertung der online erhobenen experimentellen Daten wurde beendet. Die Resultate bestätigen frühere Ergebnisse mit der untersuchten Substanz, lassen aber altersbedingte Einflüsse erkennen.
Informationen zu kommenden Studien erhalten Sie im Prüfzentrum HPR Dr. Schaffler GmbH/ Heisenbergbogen 1 (Europa Forum I) in D-85609 Aschheim-Dornach bei München unter der Telefonnummer 089-99322-0, Sprechzeiten von 10-17 Uhr.