Real-world treatments for companion animals could be a source for new drugs for humans . Andrew Warmington reports from an American College of Toxicology webinar
The truth about cats and dogs
Real-world treatments for companion animals could be a source for new drugs for humans . Andrew Warmington reports from an American College of Toxicology webinar
The primary advantage of using a translational medicine approach to develop a human drug is " the collection of safety endpoints in a relevant disease model ,” said Dr Jay Stallons of Tiresias Consulting , a non-clinical toxicologist who was formerly with Elanco Animal Health and Sangamo Therapeutics .
Stallons was speaking during a recent American College of Toxicology ( ACT ) signature webinar entitled ‘ Translation Between Veterinary and Human Medicine to Improve Clinical Outcomes in Drug Development ’. The ‘ translational medicine ’ he was referring to means studies carried out to develop veterinary drugs for spontaneous and naturally occurring diseases in companion animals , mainly dogs , cats and horses .
Collecting safety endpoints , Stallons added , is an extremely valuable means of getting the drug into the clinic . It enables users to assess safety and efficacy in the same species and in the same study in a naturally occurring disease model that has a high degree of similarity to the human disease .
Need to reduce failures
The potential is obvious . Bringing a drug to the market is massively expensive ( usually over $ 1 billion ) and time-consuming ( typically ten years ) and most fail in clinical trials . Over 50 % of the budget may be spent to get to Phase I , but the likelihood of ultimate approval at this point is about 8 %. This varies by indication and modality ; biologics have a higher approval rate ( 9.1 %) than small molecules ( 5.7 %).
By Phase III , 95 % of the budget has usually been spent , so failure at this stage can be catastrophic . In all , 17 % of all Phase III failures are attributed to safety outcomes . This rises to 26 % for cardiovascular indications , while it is lower for oncology and orphan drugs . The majority fail at this stage because of efficacy considerations , a smaller number for other reasons like strategic or business considerations .
The high rate of failures on safety grounds , Stallons said , suggests that our non-clinical models may not be predicting everything that happens in human clinical trials . The standard paradigm is certainly very good at predicting some endpoints but not so good with others . The literature varies considerably in its conclusions about why that is , depending on the symptom .
The pharmaceutical industry clearly has a huge interest in reducing attrition in its development in order to improve the predictability of the pre-clinical and non-clinical models it uses . The means it is using new methods , including spatial multi ‘ omics and epigenomics , among others .
Similarities abound
Translational medicine is another approach to reducing attrition and it is a complement to , rather than an alternative for , the tools that are already in place , Stallons noted . It is also part of One Health , a globally recognised approach that attempts to integrate and optimise the health of people , animals and ecosystems .
There are strong similarities between many human and companion animal diseases , notably glioblastoma , immune-mediated keratitis , hypertrophic cardiomyopathy and inflammatory bowel disease . There is also a strong infrastructure for veterinary clinical trials already in existence ; 679 drug trials have been officially registered since 2016 , not including those sponsored by pharmaceutical companies and which have not been officially registered .
“ In many ways , veterinary trials are very similar to human trials , in terms of such factors as genetic diversity in the animals ,” Stallons said . “ Unlike laboratory animals , companion animals
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