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A new update from Celine:
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A new update from the company… things are progressing:
One step closer to a dog longevity drug: What LOY-002’s safety milestone means to a practicing vet
Our North Star as a company is to bring to market the first drug approved by the FDA for lifespan extension in dogs. Today, we’re excited to share that we’re one step closer to achieving that goal: the FDA’s Center for Veterinary Medicine has accepted the Target Animal Safety (TAS) section of our Expanded Conditional Approval (XCA) application for LOY-002, Loyal’s lead drug candidate.
LOY-002 aims to address the metabolic dysfunction that all dogs experience as they age, delaying the start of many diseases that reduce quality of life for senior dogs and giving dogs, and their human family, more enjoyable time together. If we achieve approval and bring this drug to veterinarians, it will be a powerful new treatment for potentially millions of senior dogs.
Our general strategy for extending healthy lifespan in dogs is to use our understanding of the fundamental biology of aging to target specific aging mechanisms (like metabolic dysfunction) that reduce the quality and length of life. Rather than waiting for aging to damage health and then reacting to the diseases that occur, we take a proactive approach. We aim to prevent the harm of aging before it happens and preserve function and health. This approach comes with many significant scientific and regulatory challenges. One of the most important is the issue of safety.
All medicines have potential risks as well as benefits, and veterinarians routinely balance these to achieve a net-positive outcome for each patient. When a dog has disease that is causing significant suffering or is likely to be fatal, such as cancer, medicines that reduce suffering and prolong life can be beneficial even if they have significant negative effects. Chemotherapy is an example of this, and while it commonly causes undesired effects, such as nausea or a decrease in immune system function, these are worth coping with for a short while if the patient is likely to end up with a meaningful period of good quality life they couldn’t have had without treatment.
Read the full article: One step closer to a dog longevity drug: What LOY-002’s safety milestone means to a practicing vet