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Nonclinical cardio safety combo
ALDERLEY PARK, U.K. & LAUTREC, France—ApconiX, which provides expert nonclinical safety strategies and ion channel screening procedures to maximize the value of pharmaceutical assets at all stages of drug discovery and development, has announced its alliance with PhysioStim, a contract research organization that specializes in advanced study models to evaluate cardiac safety.
The new alliance, which was launched officially at the Safety Pharmacology Society Annual Meeting in Berlin in September, has created the European Centre of Excellence for preclinical cardiovascular electrophysiology. Both partners will handle the marketing and share the financial returns of the alliance.
Cardiovascular toxicity is one of the primary reasons for safety-related project failure in drug development. In addition, organizations that outsource their work may lack the internal capability to analyze data for specific drug programs. Companies can avoid these issues with the combination of high-throughput ion channel screening, advanced cardiovascular safety testing models and experienced project scientists offered by the new center in one collaborative team.
The European Centre of Excellence will provide a complete range of preclinical cardiac safety studies, including automated electrophysiology providing hERG screening and CiPA ion channel assays, GLP compliant assays, manual patch-clamp assays (hERG, hNav1.5, hCav1.2), action potential recordings, Langendorff models and cardiac contractility studies. In addition to offering a complete set of preclinical cardiac safety studies—from screening to customized problem-solving studies; both in the GLP and non-GLP format—the center will enable its clients to benefit from a single contact person to directly access the companies’ expert electrophysiologists and toxicologists to help them to interpret study and assay data and define the implications for each drug project.
From target review to regulatory approval, ApconiX, founded in 2015, helps organizations to assess, reduce and manage potential risk factors in order to make better decisions in selecting the right drug candidate. Company experts design and deliver the optimal nonclinical strategy to quickly implement clinical programs in order to obtain marketing approval and bring safe, effective and profitable drugs to the market. PhysioStim’s areas of expertise are electrophysiological studies, preclinical resources and ICH S7B guidelines in accordance with GLP. The company was founded in 2000.
The new Centre of Excellence is designed to help large and small pharmaceutical and biotech R&D companies who develop new drugs and compounds to make better decisions when it comes to selecting the optimal clinical lead candidate at an early stage. Such companies need to determine the right lead candidates early in the drug development process. In the preclinical study phase, inefficient screening of potential lead candidates could result in huge R&D costs for drug projects that will ultimately need to be scrapped because of toxicity issues.
The alliance “will give our clients unique access to a full range of high-quality services, from standard study models to more complex human cardiomyocyte-derived hiPSC models,” explained Marie Le Grand, CEO of PhysioStim. “They will benefit from our complementary expertise and the latest techniques to obtain the most effective results on platforms that are entirely dedicated to cardiac safety.”
“Clients will benefit from a single point of contact to access a broad range of assays and extensive expertise in cardiac safety,” added Michael Morton, director and co-founder of ApconiX. PhysioStim, he noted, brings “significant experience and GLP-compliance to our comprehensive know-how in ion channel screening and drug development.”
In other recent ApconiX news, the company announced its partnership with Sygnature Discovery, reportedly the United Kingdom’s largest independent provider of integrated drug discovery resources and expertise. The company expects the alliance to provide extra value and capabilities, especially in the area of toxicology, and expedite the discovery of new medicines from the lab into development for clients.
Dr. Paul Clewlow, senior vice president of business development at Sygnature Discovery, said, “Toxicology and functional electrophysiology assessments are essential aspects of the drug discovery and development process to ensure the safety of a potential drug prior to administration in humans. The alliance will be mutually beneficial, and together we can offer a more comprehensive integrated approach to any client’s drug discovery program.
Morton concluded, “The combination of our expertise in discovery toxicology and ion channel testing, with that of Sygnature’s medicinal chemistry-driven integrated drug discovery services, will help clients to make safer drugs. Our ability to run high-throughput screens for important ion channel targets also complements Sygnature’s extensive biology capability.”