Advancing Outcomes Through Innovation

Press: Innovative Liver Tech

Empiriko Brings Game-changing Technology to Drug Discovery and Clinical Research Industry

Empiriko Brings Game-changing Technology to Drug Discovery and Clinical Research Industry

Company’s Innovative Chemosynthetic Liver Technology Reveals More Complete Metabolism Profiles, Reduces Animal Studies, Achieves Significant Cost Savings, Enables Better Patient Treatment

Newton, Mass. – January 21, 2014 – Empiriko, an innovative clinical intelligence company, today announced the availability of its Biomimiks™ technology, a game- changing biomimetic platform that mimics the in vivo metabolism mediated by liver enzymes (cytochrome P450) to enable pharmaceutical researchers to conduct rapid and iterative in vitro and ex vivo drug metabolism studies to predict the metabolic patterns, pathways and profiles of drugs.

A dramatic step forward for the drug discovery industry, Empiriko’s chemistry-based solutions address the full drug development lifecycle, from lead generation to patient treatment, helping pharmaceutical companies:

  • Generate and predict more complete metabolic profiles to develop new chemical entities (NCEs), including reactive metabolites that may be responsible for drug toxicity

  • Produce multi-gram volumes of metabolites required for ongoing research and testing with our high yield catalysts

  • Improve safety testing and reduce later-stage attrition rates by predicting and preventing toxicity earlier in development

  • Improve patient treatment by identifying and preventing harmful drug-drug interactions

  • Significantly reduce animal testing by replacing these tests with animal-free chemistry

According to PhRMA, only one of every 10,000 potential medicines investigated by U.S. research-based pharmaceutical companies is approved by the FDA. Winning approval takes on average 15 years of research and development, with costs exceeding $1.2 billion. Even after drugs are approved, regulatory agencies require pharmaceutical companies to conduct post-market safety and surveillance programs to report and assess adverse reactions.

Since most adverse drug reactions are associated with drug metabolites, metabolic processes of drugs are often the subject of intense scrutiny. Metabolism profiling, which is conducted relatively late in the drug discovery process, is a widely-used means of identifying potential toxicity and side effects, and selecting the best drug candidates for further study. However, the present-day process of studying metabolites involves the use of liver slices and bodily fluids extracted from animals – an approach that is costly, labor-intensive and chemically inconclusive.

Empiriko’s Biomimiks™ solutions address these current challenges faced by pharmaceutical companies by providing a more conclusive, chemistry-based metabolism profiling method that significantly reduces time, costs and animal testing.

“Biomimiks™ is disruptive technology that can change the way drugs are designed, developed and administered,” stated Pam Randhawa, Empiriko’s Founder and CEO. “Since it is chemistry-based, Biomimiks™ provides an animal-free platform for producing and screening drug metabolites across the entire drug lifecycle. Now scientists and clinical researchers can design and develop drugs in a more iterative and agile manner – identifying safety and efficacy issues earlier-on. We’re confident the industry will benefit substantially from our approach, and we’re excited about the path forward.”

“Biomimiks™ chemosynthetic liver technology establishes a new paradigm for drug discovery and development,” said Mukund Chorghade, Empiriko’s Chief Scientific Officer and Founder. “Our technology ensures speed, stability, scalability and predictability in drug synthesis and evaluation – based on a more complete picture of drug metabolites. With Biomimiks™ scientists can focus their time and resources on the most promising drug candidates, preventing the high cost of later stage withdrawals. In addition, clinicians can use Biomimiks™ to dynamically and proactively measure a patient’s response to a spectrum of drugs (drug-to-drug interactions, dosing levels and regimens), and incorporate the results into more effective diagnosis and patient treatment.” Empiriko’s Biomimiks™ Solutions – From Drug Discovery to Patient Treatment

  • Solutions for Drug Discovery: In Vitro
    With Biomimiks™ scientists can quickly screen a series of compounds by reacting them with permutations of our patented oxidative catalysts, co-oxidants and non-aqueous solvents. This powerful combination serves as an “in vitro cocktail” that reduces the elapsed time for drug screening from several days to hours. And scientists can quickly validate metabolite structures via spectroscopy – and have plenty of metabolite standards left for toxicology and pharmacology testing. Now scientists can conduct more complete in vitro metabolism studies, confirm structure and generate quantitative measures of toxicity, focusing their time and resources – more confidently – on the most promising drug candidates.

  • Solutions for Clinical Research: Ex Vivo
    With Biomimiks™ clinical researchers can conduct metabolism studies as part of their clinical trials. This allows them to dynamically measure the patient’s metabolic response (drug-to-drug interactions, dosing levels and regimens) to a spectrum of drugs in order to incorporate the results into more effective patient treatment and regulatory submissions.

  • Solutions for Patient Treatment: Ex Vivo
    Before prescribing a new additional drug to a patient, Biomimiks™ technology enables clinicians to use a patient’s biological phenotypes to study metabolic profiles of drugs that patient is currently taking. The metabolic patterns are compared with those of single drugs to determine attenuation or suppression of metabolites, in order to assess the safety of a specific drug for the patient. The metabolic patterns can be further analyzed within the context of clinical history of the patient to assess drug-to-drug interactions and efficacy associated with adding a new drug to a patient’s drug regimen. This will enable clinicians to match the right combination of drugs to the right patient and achieve the best outcome for the patient.

Empiriko, which remains privately-funded, is working with key scientists from world- renowned research institutions (including Harvard University in Cambridge, MA, Northeastern University in Boston, MA, Caltech in Pasadena, CA, Cambridge University in Cambridge, UK, Massachusetts General Hospital in Boston, MA and New England Biolabs in Ipswich, MA). The company was recognized for its innovation in medicinal chemistry at the 2013 American Chemical Society National Meeting and Exposition. The winning poster presentation, “Metalloporphyrins as synthetic livers,” was authored by Chiara Chapman and Professor Graham Jones (Northeastern University’s Department of Chemistry and Chemical Biology), and Empiriko’s Co-founder and Chief Scientific Officer, Mukund Chorghade, and Dr. Anjali Rahatgaonkar.

The Empiriko Team

Empiriko’s leadership brings together a seasoned management team with business executives and award-winning scientific experts, including two Nobel Prize winners. Founder and CEO Pam Randhawa, MPM, has more than 15 years experience in the healthcare and life sciences industries and was previously the Vice President of Strategic Development at Sermo and Vice President of Global Marketing at Phase Forward (now Oracle), and she held senior-level product management positions at McKesson. Co-founder and Chief Scientific Officer, Mukund Chorghade, has more than 25 years of experience in drug discovery and development at Genzyme (now Sanofi), and Abbott Laboratories as well as research at Dow Chemicals. He also founded THINQ Pharma, focused on discovering novel compounds and hybrid molecules.

The company is also moving to 275 Grove Street, Newton, MA. The new headquarters will accommodate the company’s plans for growth in 2014.

Resources and Materials
Whitepaper: http://www.empiriko.com/media/Biomimiks_White_Paper.pdf
Video: http://www.youtube.com/watch?v=6C1pE0LS8i8
Webinar: http://www.empiriko.com/news-events/biomimicking-cytochrome-p450-predict...

About Empiriko

Empiriko is a clinical intelligence company that leverages chemistry-based experimental research and in silico modeling to provide solutions in drug discovery, development and patient outcomes by combining scientific research and clinical observations with leading- edge technologies and advanced analytics. To achieve a higher level of predictive power, Empiriko has designed in vitro and ex vivo biomimetic systems – Biomimiks™ – that function as “chemosynthetic livers” to generate and predict metabolic profiles of drugs, which identify New Chemical Entities (NCEs) and reduce drug attrition rates. Empiriko's Biomimiks™ technology offers a significant advancement in rational drug development and lays the predictive foundation for emulating CYP enzymes, function, mechanism and reactivity. With Biomimiks™ pharmaceutical researchers can now apply a new level of proactive intelligence – aimed at developing better and safer compounds by conducting early metabolism studies, generating quantitative measures of toxicity and reducing the necessity of animal experimentation. For personalized patient treatment, clinicians can now analyze metabolic patterns to assess drug-to-drug interactions and the safety and efficacy associated with adding a new drug to a patient’s drug regimen.

For more information, visit http://www.empiriko.com

Biomimiks™ is a trademark of Empiriko Corporation. All other company and product names are trademarks or registered trademarks of their respective holders.