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Loyal Receives FDA Acceptance Of Reasonable Expectation Of Effectiveness For Senior Dog Lifespan Extension
An overview of Loyal's three drugs in development: LOY-001, LOY-002, and LOY-003 (Photo: Business Wire)Pioneering canine longevity company is one step closer to delivering an FDA-approved drug that will help dogs live longer, healthier lives and closes $22M B-2 funding round
SAN FRANCISCO, February 26, 2025--(BUSINESS WIRE)--Loyal, a clinical-stage animal health company developing longevity drugs for dogs, announced today that the FDA's Center for Veterinary Medicine has accepted the Reasonable Expectation of Effectiveness (RXE) section of its conditional approval application for LOY-002. The drug aims to extend the lifespan of senior dogs and maintain their quality of life as they age, building on the company's previous RXE acceptance for a longevity drug specifically targeting the short lifespan of large breed dogs.
The company also announced it has raised a $22M million B-2 round from Valor Equity Partners and Collaborative Fund, among others, in addition to its $45M Series B in 2024. This brings total investment in Loyal's to over $150M.
"Everything we do is in service of helping dogs live longer, healthier lives," said Loyal Founder and CEO Celine Halioua. "These two milestones represent our ongoing commitment to that mission through years of diligence and hard work. Proving efficacy is one of the most challenging parts of developing a novel drug. While we still have significant work to do, RXE increases the probability that dogs will soon have access to our longevity drugs."
A New Preventive Paradigm
The FDA's Center for Veterinary Medicine has determined that Loyal's data provides reasonable expectation of LOY-002's intended effect of extending canine lifespan, marking a significant milestone in the company's pursuit of conditional approval.
LOY-002, a daily flavored tablet developed for dogs aged 10 and older weighing at least 14 pounds, represents a groundbreaking approach to canine longevity by targeting metabolic dysfunction, one of the key underlying mechanisms of aging. This preventive therapy aims to reduce the incidence and severity of age-associated diseases that diminish senior dogs' quality of life, offering a practical alternative to established longevity interventions like caloric restriction.
The FDA's acceptance of RXE demonstrates confidence in Loyal's innovative approach, and the company anticipates completion of the manufacturing and safety requirements for Expanded Conditional Approval (XCA) from the FDA by the end of 2025.
"Loyal's progress in bringing their products to market continues to impress, especially since they are breaking new regulatory ground," said Dr. Linda Rhodes, VMD, PhD, a veterinarian and experienced animal health executive who serves on Loyal's Board of Directors.
Story Continues
As the company pursues its XCA application, Loyal is simultaneously running its groundbreaking clinical trial, the STAY study. The STAY study is LOY-002's pivotal efficacy study that dosed its first dog in December 2023 and will take place over approximately four years. It is the first and only FDA-concurred clinical trial for longevity and is the largest veterinary trial in history, recruiting over 1,000 dogs from 70 veterinary clinics across the country.
"Achieving RXE acceptance is a testament to the ongoing importance of the STAY study," said Dr. Ellen Ratcliff, VP of Clinical and Veterinary Medicine at Loyal. "Completing enrollment and seeing what the data shows over the next several years is critical, but this is an important step in the process. We now have validation from one of the highest quality regulatory agencies in the world that the drug we're testing has a reasonable expectation of extending a dog's life."
B-2 Fundraising Round
In addition to achieving RXE for its second drug program, Loyal successfully completed a $22M B-2 funding round, led by Valor Equity Partners and Collaborative Fund, among others. Along with his investment in Loyal, Jonathan Shulkin, Partner and Co-President at Valor Equity Partners, is joining the company's Board of Directors.
This raise represents a significant premium on the Loyal's Series B last year and will support the company's execution of key go-to-market efforts to bring LOY-002 to veterinarians and dog owners soon, in addition to advancing the other drugs in development across its portfolio: LOY-001 and LOY-003, which are designed to extend the healthy lifespan of large-breed dogs.
About Loyal
Loyal is an animal health company developing the first drugs intended to help dogs live longer, healthier lives. By targeting the underlying mechanisms of aging, Loyal hopes to extend the lifespan of dogs and improve their quality of life as they age. Loyal's work is based on decades of research, and their team of experts in dog health and longevity is dedicated to furthering this research and developing better ways to quantify and improve the aging process in dogs. It currently has three drugs in development and is making progress toward approval from the FDA's Center for Veterinary Medicine.
For more information, please visit loyal.Com.
View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20250226676005/en/
Contacts
Press Contact:Isabelle WoodCommunications Manager415-320-6360press@loyal.Com
Second Drug For Canine Healthy Lifespan Extension Receives FDA Support
Loyal's developmental therapy aims to increase longevity and quality of life for senior dogs
A developmental drug that aims to extend the healthy lifespan of senior dogs has received acceptance by the FDA's Center for Veterinary Medicine for the Reasonable Expectation of Effectiveness (RXE) section of the conditional approval application submitted by Loyal, a clinical-stage animal health company. The drug, LOY-002, targets age-related metabolic dysfunction and is also designed to improved quality of life in canines aged 10 years and older weighing at least 14 lbs.1
"Loyal's progress in bringing their products to market continues to impress, especially since they are breaking new regulatory ground," Linda Rhodes, VMD, PhD, a member of Loyal's Board of Directors, said in a news release.1
This new RXE is the second to receive acceptance by the FDA for a longevity drug developed by Loyal. The first, LOY-001, received RXE acceptance in November 2023. LOY-001 is a prescription injection that targets large- and giant-breed dogs such as rottweilers, Great Danes and Bernese Mountain dogs, according to Celine Halioua, CEO of Loyal.2
A third longevity drug, LOY-003, is also in Loyal's pipeline. LOY-003 is a prescription pill that aims to provide the same benefits to the large- and giant-breed canine population as LOY-001. Both LOY-001 and LOY-003 intend to target dogs aged 7 years and older, weighing at least 40 lbs.1
Clinical studyLoyal is currently running the STAY clinical study to further examine LOY-002, and to provide effectiveness and field safety data for its' FDA application for drug approval. Launched in late 2023, the STAY study is expected to run 4 years with 1000 dogs enrolled at dozens of independent veterinary clinics across the US. Half of the enrolled dogs are receiving a beef-flavored LOY-002 pill while half of the study enrollees receive a placebo.3
In a dvm360 interview, Ellen Ratcliff, DVM, vice president of clinical and veterinary medicine at Loyal, said the study has been running in approximately 70 US veterinary clinics. Participation is being recorded in rural, urban and large metropolitan areas. "[It is] just a lot of really great engagement with veterinarians," she said. "One of the neat things about the STAY study is that we are using a lot of clinical trial-naïve study sites—veterinarians who have never participated in clinical research or doing clinical research at their clinics."
The STAY study dosed its' first dog, a Whippet named Boo, in December 2023. This study is the first and only FDA-concurred clinical trial for longevity and is the largest veterinary trial in history, according to Loyal.1,3
"It doesn't do anybody any good if their dog lives longer, but they live longer in that period at the end of the life where they don't feel well, and they're sick, having all kinds of degenerative and aging diseases. So, the STAY study is also measuring quality of life according to the owner and the owner assessment of the dog's quality of life," Ratcliff said.
Financial supportIn announcing the RXE for LOY-002, officials with Loyal also said the company has raised $22 million for its' B-2 round, from investors that include Valor Equity Partners and Collaborative Fund. Combined with $45 million in Series B funding it raised in 2024, Loyal now has investment of more than $150 million.
"Everything we do is in service of helping dogs live longer, healthier lives," Halioua said in the release. "These 2 milestones represent our ongoing commitment to that mission through years of diligence and hard work. Proving efficacy is one of the most challenging parts of developing a novel drug. While we still have significant work to do, RXE increases the probability that dogs will soon have access to our longevity drugs."
The funding raised will support Loyal's efforts to bring LOY-002 to the market for veterinarians and dog owners. These funds will also help advance LOY-001 and LOY-003, according to the company.
TakeawayLoyal is pursuing the FDA's expanded conditional approval and company officials anticipate completion of manufacturing and safety requirements for this application by late 2025. Regardless, Ratcliff noted that RXE acceptance is an achievement that serves as a testament to the importance of the STAY study.
"Completing enrollment and seeing what the data shows over the next several years is critical, but this is an important step in the process. We now have validation from one of the highest quality regulatory agencies in the world that the drug we're testing has a reasonable expectation of extending a dog's life," Ratcliff said in the release.1
References
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