- The unfolding crisis created by the coronavirus pandemic is triggering extraordinary efforts by the scientific community to generate new antiviral medications.
- There are two principal strategies for antiviral drug development: (1) repurpose existing drugs (or combinations thereof) or (2) develop a new antiviral medication. While both strategies are being fast-tracked at each stage of the drug discovery process, a successful response to this emergency will require BOTH an accelerated timeline AND accurate, reliable data to ensure new drugs are safe and effective.
- The traditional paradigm for assessing a new drug’s potential safety and efficacy utilizes animal models. Unfortunately, new drugs that are effective and safe in rodents or dogs are frequently ineffective—or worse, toxic—when administered to humans, which is why more than 90% of drugs that begin the drug discovery process are never approved by the FDA for commercial use. This abysmal success rate will only hinder our ability to fight the growing coronavirus pandemic in a timely manner.
A Unique Opportunity to Accelerate Coronavirus Drug Discovery
- Over the last 10 years, AnaBios has developed and validated a novel approach to drug discovery that relies on utilizing human tissue and organs obtained ethically from donors, for drug screening and preclinical testing. The technology that makes these ‘clinical-trials-in-a-dish’ possible includes methods and solutions that keep the human tissue samples alive after they are recovered from an organ donor. All samples are then shipped to AnaBios’ laboratory in San Diego, where tests are conducted to measure a drug’s effects on the human tissue samples. AnaBios routinely partners and collaborate with pharmaceutical companies to offer access to its innovative drug screening paradigm.
Powerful Technology to Accelerate Drug Development
- Over the last decade, AnaBios has validated its innovative approach by comparing the results obtained with our human tissue platform with those obtained in clinical trials and have demonstrated a high level of correlation. We have published validation studies conducted in collaboration with pharmaceutical companies (including AbbVie, Amgen, Novartis, and Roche), and routinely help them accelerate their drug discovery programs. In addition, we have a successful history of collaborating with the NIH and FDA, in particular the Cardiac and Renal Division at the Center for Drug Evaluation and Research (CDER).
Partnership with the FDA
- In collaboration with the teams of Dr. Norman Stockbridge, Director of Division of Cardiovascular and Renal Products, FDA CDER, and Dr. David Strauss, Director of Division of Applied Regulatory Science, FDA CDER, we are conducting research on the cardiac safety and tolerability of drugs currently approved and in clinical use. In addition, we are engaged in formal Biomarker Qualification discussions with the FDA to validate specific parameters that could further assist in the identification of drug-induced cardiac arrhythmia. Finally, AnaBios recently announced a Research Collaboration Agreement with the group led by Dr. Strauss, to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function.
Other Emergencies Tackled by AnaBios Using Human Tissue Paradigm
- AnaBios is also deploying its technology in the battle against the opioid overdose epidemics and has received an Innovation Award from the National Center for Advancing Translational Sciences (NCATS) at the National Institute of Health (NIH) for “Biological Assays for Translational Innovation in Pain, Opioid Use Disorder and Overdose.”
AnaBios and our team of scientists are eager to help. We strongly believe that our human-based discovery platform can accelerate treatment identification for the coronavirus and hasten the time it will take to develop a life-saving antiviral medication. For example, selecting an antiviral treatment from existing drug combinations will require cardiac safety assessments of all novel combinations, which could take years. The quickest—and most reliable—way to assess the risk of cardiac toxicity of any new antiviral drug is to test the drug in human tissues and cells. In fact, our technology and capabilities allow for the testing of dozens of drug combinations in a matter of days.
In addition, AnaBios’ technology, by providing human lung slices and tissue preparations, can help accelerate the identification of drugs that stop the virus’ infection and replication in the lungs.
AnaBios is ready to offer our proven scientific expertise and resources to help overcome this once-in-a-lifetime crisis. Together, we can quickly create safe, efficacious medicines that protect human lives.