SAN FRANCISCO--(BUSINESS WIRE)--Loyal, a biotech company pioneering longevity drugs for dogs, announced today that the Food and Drug Administration (FDA) Center for Veterinary Medicine has approved the Reasonable Expectation of Effectiveness section of Loyal’s conditional approval application for LOY-001, a drug the company is developing to extend the lifespan of large dogs and maintain their quality of life as they age..

SAN FRANCISCO-（BUSINESS WIRE）-一家为狗开拓长寿药物的生物技术公司Loude今天宣布，美国食品和药物管理局（FDA）兽医中心已批准Loude有条件批准申请的合理预期效果部分为LOY-001，该公司正在开发一种药物，以延长大型犬的寿命，并随着年龄的增长保持其生活质量。。

With this milestone, Loyal leads a shift in the medical field’s approach to treating age-associated diseases in animals. LOY-001 represents a new category of pharmaceutical, focused on targeting mechanisms of aging to prevent or delay the onset of age-associated diseases, rather than waiting for patients to get sick before treating them..

有了这个里程碑，忠诚领导了医学领域治疗动物年龄相关疾病的方法的转变。LOY-001代表了一类新的药物，专注于针对衰老机制，以预防或延迟与年龄相关的疾病的发作，而不是在治疗之前等待患者生病。。

“Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Loyal CEO Celine Halioua. “This milestone is the result of years of careful work by the team. We’ll continue to work just as diligently to bring this and our other longevity programs through to FDA approval.”.

忠诚首席执行官Celine Halioua说：“忠诚的目标是开发第一批延长狗健康寿命的药物。“这个里程碑是团队多年精心工作的结果，我们将继续努力，将这个和我们的其他长寿项目带入FDA批准。”。

The Conditional Approval Pathway

有条件的批准途径

The FDA’s Expanded Conditional Approval is an accelerated pathway for animal drugs that aims to increase the availability of innovative therapies. It’s designed for drugs that demonstrate a reasonable expectation of effectiveness in addressing an unmet medical need, but require complex and difficult studies to complete collection of definitive effectiveness data..

FDA扩大的有条件批准是动物药物的加速途径，旨在提高创新疗法的可用性。它专为在解决未满足的医疗需求方面表现出合理预期有效性的药物而设计，但需要复杂而困难的研究才能完成明确有效性数据的收集。。

Today’s milestone is a crucial part of Loyal’s application for conditional approval. It means the FDA agrees LOY-001 has a reasonable expectation of effectiveness and, once the FDA approves Loyal’s manufacturing and safety data packages, Loyal can market the drug for lifespan extension in the target canine population.

今天的里程碑是忠诚申请有条件批准的关键部分。这意味着FDA同意LOY-001具有合理的有效性期望，并且一旦FDA批准忠诚的制造和安全数据包，忠诚可以在目标犬群中销售该药物延长寿命。

Conditional approval lasts for up to five years, during which time Loyal will collect the remaining effectiveness data and apply for full approval..

有条件的批准持续长达五年，在此期间，忠诚者将收集剩余的有效性数据并申请完全批准。。

A New Approach

一种新方法

The pharmaceutical industry has historically focused on developing drugs that treat specific diseases, including those associated with aging. Treatment typically begins only when those diseases are established and patients are symptomatic.

制药行业历来专注于开发治疗特定疾病的药物，包括与衰老相关的药物。通常只有在确定这些疾病并且患者有症状时才开始治疗。

Loyal’s approach represents a different paradigm: use our understanding of the underlying mechanisms of aging to reduce the risk of these diseases in the first place. Today’s announcement shows the FDA believes Loyal’s approach is valid.

忠诚的方法代表了一种不同的范式：首先利用我们对衰老潜在机制的理解来降低这些疾病的风险。今天的公告显示FDA认为忠诚的方法是有效的。

The Center for Veterinary Medicine at the FDA has reviewed Loyal’s data, results, and scientific arguments and determined they provide reasonable expectation of the drug’s effectiveness to extend canine lifespan and healthspan. Pending successful completion of the Manufacturing and Safety sections, Loyal will receive conditional approval for LOY-001, allowing them to market the drug for large-dog lifespan extension..

FDA兽医中心审查了LOUZE的数据，结果和科学论点，并确定它们为延长犬类寿命和健康寿命提供了合理的药物有效性期望。在成功完成制造和安全部门之前，忠诚者将获得LOY-001的有条件批准，允许他们销售该药物以延长大型狗的寿命。。

Linda Rhodes, VMD, PhD, a well-known animal health industry expert with extensive experience developing animal drugs and working with the Center for Veterinary Medicine at the FDA, said: “Loyal’s achievement is impressive. Developing a treatment that will increase longevity by reducing age-associated disease is a new indication.

Linda Rhodes，VMD博士，一位在动物药物开发方面拥有丰富经验并与FDA兽医中心合作的着名动物健康行业专家表示：“忠诚的成就令人印象深刻。开发一种可延长寿命的治疗方法减少年龄相关疾病是一个新的迹象。

No drug has ever been approved with such a claim, and pioneering a new indication through regulatory agencies requires an enormous amount of rigor and persistence. Being the first to bring a treatment for such a challenging indication will be truly historic.”.

从来没有这样的说法批准过任何药物，通过监管机构开创一个新的迹象需要大量的严谨和持久性。第一个为这种具有挑战性的迹象带来治疗将是真正的历史。”。

LOY-001

LOY-001

The drug, codenamed LOY-001, is intended to extend lifespan and maintain quality of life in large- and giant-breed dogs. These breeds may have as little as half the expected lifespan of small breeds.

该药代码为LOY-001，旨在延长大型和巨型犬的寿命并保持生活质量。这些品种可能只有小品种预期寿命的一半。

Selectively breeding dogs for size is understood to cause elevated levels of the growth-promoting hormone IGF-1, and this is believed to reduce their lifespan. Large dogs have up to 28x the levels of IGF-1 as small dogs.

据了解，选择性繁殖大小的狗会导致生长促进激素IGF-1水平升高，据信这会缩短它们的寿命。大型犬的IGF-1水平高达28倍，如小型犬。

LOY-001 works by reducing IGF-1 in adult dogs to increase lifespan.

LOY-001通过减少成年犬的IGF-1来延长寿命。

Designed as a veterinarian-administered long-acting product given to dogs every three to six months, LOY-001 is anticipated to be available in 2026, subject to FDA approval of Loyal’s manufacturing and safety data.

LOY-001设计为兽医每三至六个月给予狗的长效产品，预计将于2026年上市，但须FDA批准忠诚的制造和安全数据。

The basis for the FDA’s decision today was the data submitted by Loyal, including studies showing LOY-001’s ability to reduce levels of key biomarker IGF-1 and the beneficial impact on functional outcomes in dogs. This was further supported by a large observational study of the functional and biomarker impacts of canine aging.

FDA今天决定的基础是LOUZE提交的数据，包括研究显示LOY-001降低关键生物标志物IGF-1水平的能力以及对狗功能结果的有益影响。对犬老化的功能和生物标志物影响的大型观察性研究进一步支持了这一点。

The study involved 452 companion dogs of 84 different breeds, aged two to 18. It validated the clinical relevance of the functional outcomes seen in Loyal’s earlier studies..

该研究涉及84个不同品种的452只伴侣犬，年龄在2至18岁之间。它验证了忠诚早期研究中所见功能结果的临床相关性。。

The Short Life of Big Dogs

大狗的短命

There’s a well-established inverse relationship between a dog’s size and their expected lifespan — bigger dogs live shorter lives than smaller dogs, by nearly half. Great Danes and Newfoundlands may live only seven to eight years, compared with the average lifespan of up to 20 years for Chihuahuas and Miniature Poodles..

狗的体型与预期寿命之间存在着明显的反比关系-较大的狗比较小的狗活得更短，寿命将近一半。大丹犬和纽芬兰犬的平均寿命可能只有7到8年，而奇瓦瓦犬和迷你贵宾犬的平均寿命长达20年。。

“The extreme phenotypic variety found in dogs is not ‘natural’ — it’s the result of intensive breeding by humans to create dogs that excelled at tasks such as herding, protection, and companionship,” said Brennen McKenzie, Loyal’s Director of Veterinary Medicine and previously President of the Evidence Based Veterinary Medicine Association and a practicing veterinarian.

忠诚兽医总监布伦宁·麦肯齐（Brennen McKenzie）说：“狗中发现的极端表型多样性不是'自然'-这是人类强化繁殖的结果，可以创造出在放牧，保护和陪伴等任务中表现优异的狗。医学和以前的循证兽医协会主席和执业兽医。

“At Loyal, we see the short lifespan of big dogs not as inevitable, but as a genetically-associated disease caused by historical artificial selection, and therefore amenable to targeting and treatment with a drug.”.

“在忠诚中，我们看到大狗的寿命短并非不可避免，而是由历史人工选择引起的遗传相关疾病，因此适合用药物靶向和治疗。”。

Historical selective breeding is one of the causes of genetically-associated diseases such as cancers in Golden Retrievers, hip dysplasia in German Shepherds, and canine brachycephalic syndrome in Bulldogs. In large and giant breed dogs, breeding for size causes these dogs to have elevated levels of IGF-1, a hormone that drives cell growth, and is believed to reduce their lifespan..

历史选择性育种是遗传相关疾病的原因之一，例如金毛猎犬的癌症，德国牧羊人的髋关节发育不良和斗牛犬的犬短头综合征。在大型和巨型犬中，按大小繁殖会导致这些犬的IGF-1水平升高，IGF-1是一种驱动细胞生长的激素，据信会缩短其寿命。。

“Ever since we invested in Loyal in 2021, the team has made tremendous progress with the FDA, legitimizing an entirely new category of pharmaceuticals through their efforts,” said Vinod Khosla, Founder, Khosla Ventures. “Today’s announcement marks a first for any longevity drug, and is a big step towards accelerating the path for canines, and ultimately humans.”.

Khosla Ventures创始人Vinod Khosla说：“自2021年我们投资LOUDE以来，该团队在FDA方面取得了巨大进步，通过他们的努力使全新一类药物合法化。”。“今天的公告标志着任何长寿药物的第一个，是加速犬科动物和最终人类道路的重要一步。”。

About Loyal

关于忠诚

Loyal is a biotech startup 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 maintain their quality of life as they age.

忠诚是一家生物技术初创企业，开发第一批旨在帮助狗活得更长，更健康的生活的药物。通过针对衰老的潜在机制，忠诚希望延长狗的寿命并随着年龄的增长保持他们的生活质量。

For more information, please visit loyalfordogs.com.

欲了解更多信息，请访问loyalfordogs.com。