Recent Milestones Aim to Bring a New Category of Care to One of Veterinary Medicine's Largest Unmet Needs

近期的里程碑旨在为兽医学中最大的未满足需求之一带来一个新的护理类别

Gallant granted eligibility for expanded conditional approval by FDA-CVM for canine osteoarthritis (OA) stem cell therapy; targeting conditional approval in 2028.

Gallant 获得 FDA-CVM 批准的扩大条件性许可，用于犬骨关节炎 (OA) 干细胞治疗；目标是在 2028 年获得条件性批准。

Randomized, blinded, placebo-controlled pilot study shows statistically significant improvement in Gallant's uterine-derived mesenchymal stromal cell (UMSC) treated dogs for validated pet parent outcomes.

随机、盲法、安慰剂对照的初步研究表明，Gallant 的子宫源间充质基质细胞 (UMSC) 治疗的狗在经宠物主人验证的结果中显示出统计学上的显著改善。

No treatment-related serious adverse events observed; early data supports the safety of repeated dosing with donor-derived UMSCs

未观察到与治疗相关的严重不良事件；早期数据支持供体来源的UMSCs重复给药的安全性。

SAN DIEGO

圣地亚哥

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，

May 6, 2026

2026年5月6日

/PRNewswire/ -- Gallant, an animal health biotechnology company pioneering off-the-shelf mesenchymal stromal cell (MSC) therapies for pets, today announced that its canine osteoarthritis (OA) MSC therapy program has been granted eligibility to use the U.S. Food and Drug Administration Center for Veterinary Medicine's (FDA-CVM) expanded conditional approval pathway.

/PRNewswire/ -- Gallant是一家致力于为宠物开发现成的间充质基质细胞（MSC）疗法的动物健康生物技术公司，今天宣布其针对犬骨关节炎（OA）的MSC治疗计划已获准使用美国食品药品监督管理局兽医中心（FDA-CVM）的扩展有条件批准途径。

The company also announced positive results from a randomized, placebo-controlled pilot study evaluating intravenous (IV) UMSCs in client-owned dogs with naturally occurring OA..

公司还宣布了一项随机、安慰剂对照的小型试点研究的积极结果，该研究评估了静脉注射（IV）UMSCs在自然发生OA的客户拥有的狗中的效果。

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Gallant today announced FDA-CVM expanded conditional approval pathway eligibility for its canine osteoarthritis stem cell therapy program, alongside positive results from a randomized, placebo-controlled pilot study showing statistically significant improvement in UMSC-treated dogs on validated pet parent-reported outcome measures at Day 60 and 90.

Gallant 今天宣布其犬骨关节炎干细胞治疗项目已获得 FDA-CVM 扩展条件批准路径的资格，同时一项随机、安慰剂对照的初步研究显示，在第60天和第90天，接受 UMSC 治疗的犬只在经过验证的宠物主人报告结果指标上取得了统计学上显著的改善。

Conditional approval is targeted for 2028..

有条件批准的目标是在2028年。

The announcement comes as the veterinary community marks Arthritis Awareness Month. OA is a common and often underdiagnosed condition, affecting more than 20% of dogs over one year of age, 40% of dogs four years of age, and up to 80% of dogs over eight years of age. Despite its prevalence, the disease is frequently misunderstood as a wear-and-tear disease associated with age-related joint degeneration, which has real consequences for how and when dogs receive care..

该公告发布之际，兽医界正在纪念关节炎宣传月。骨关节炎 (OA) 是一种常见且经常被低估的疾病，影响着超过 20% 的一岁以上的狗、40% 的四岁的狗，以及高达 80% 的八岁以上的狗。尽管这种疾病很普遍，但它常被误解为与年龄相关的关节退化引起的磨损性疾病，这对狗狗何时以及如何接受治疗产生了实际的影响。

Research has established that pro-inflammatory processes driven by both local and systemic immune activity play a central role in the onset and progression of OA. The disease commonly affects young dogs, and cartilage degeneration, once underway, is progressive. MSC therapy, which works by modulating these immune pathways, targets the root cause of disease..

研究已经证实，由局部和全身免疫活动驱动的促炎过程在骨关节炎（OA）的发病和进展中起着核心作用。该疾病通常影响年轻的狗，且软骨退化一旦开始，便会逐步恶化。间充质干细胞（MSC）疗法通过调节这些免疫通路，针对疾病的根源发挥作用。

The study enrolled 88 client-owned dogs with radiographically confirmed OA and observable lameness or pain in at least one affected peripheral joint. Dogs were randomly assigned to receive two intravenous injections, administered 14 days apart, of either UMSCs or a saline placebo. Dogs were assessed by pet parents and veterinarians through Day 90, which served as the primary efficacy endpoint..

该研究招募了88只患有放射学确认的骨关节炎（OA）并且至少一个受影响的外周关节出现跛行或疼痛的客户拥有的狗。这些狗被随机分配接受两次静脉注射，间隔14天，注射内容为UMSCs（脐带间充质干细胞）或生理盐水安慰剂。狗在第90天之前由宠物主人和兽医进行评估，这作为主要疗效终点。

Dogs receiving UMSCs demonstrated significant improvement compared to placebo in validated pet parent-reported outcome measures at Day 60 and 90. Pet parent and veterinarian assessments of mobility, quality of life and pain consistently favored the UMSC–treated group.

接受UMSCs治疗的狗在第60天和第90天经过验证的宠物主人报告结果指标中显示出比安慰剂组显著改善。宠物主人和兽医对活动能力、生活质量和疼痛的评估始终倾向于UMSC治疗组。

No treatment-related serious adverse events were observed, and these early findings support the safety of repeat IV dosing with donor-derived UMSCs.

未观察到与治疗相关的严重不良事件，这些早期研究结果支持了重复静脉注射供体来源的UMSC的安全性。

'In this pilot study, we're pleased to see that repeat IV dosing was well tolerated, with positive signals across key outcomes in dogs with osteoarthritis,' said Dr. Rebecca Windsor, DVM, DACVIM, vice president of Veterinary Affairs at Gallant. 'By targeting the systemic and local immune dysregulation that precedes the progressive, degenerative changes of OA, MSC therapy has the potential to not only control clinical signs but also impact the course of disease.'.

“在这项初步研究中，我们很高兴地看到重复静脉注射剂量被很好地耐受，并且在患有骨关节炎的狗的关键结果上出现了积极信号，”Gallant公司兽医事务副总裁Rebecca Windsor博士说道。“通过针对系统性和局部免疫失调，这种失调先于骨关节炎的进行性、退行性变化，MSC疗法不仅有可能控制临床症状，还可能影响疾病的进程。”

A key feature of Gallant's approach is the IV delivery route. Historically, cell therapy for OA has meant injection directly into the joint (or often multiple joints) - a procedure that requires sedation or anesthesia, specialized training and often referral to a specialist. Gallant's ready-to-use, off-the-shelf therapy is designed for simple IV administration, so it's easily accessible to all veterinarians, for any dog that needs it, in any practice setting..

Gallant方法的一个关键特征是静脉注射途径。历史上，针对骨关节炎的细胞治疗意味着直接注射到关节中（或通常是多个关节）——这一过程需要镇静或麻醉、专业培训，并且常常需要转诊给专科医生。Gallant即用型、现货供应的疗法旨在通过简单的静脉注射进行管理，因此在任何执业环境中，所有兽医都可以轻松获取并为任何需要的狗进行治疗。

The FDA granted Gallant expanded conditional approval eligibility for both its canine and feline OA programs, a regulatory designation expected to bring these therapies to market earlier, meeting a well-established unmet medical need with potential conditional approval targeted for 2028.

FDA 授予 Gallant 其犬类和猫科动物 OA 项目更广泛的有条件批准资格，这一监管认定有望让这些治疗更早进入市场，满足一个长期未被满足的医疗需求，预计有条件批准将在 2028 年实现。

'This is another positive step toward revolutionizing how we treat OA in dogs,' said Dr. Linda Black, DVM, Ph.D., CEO of Gallant. 'We're encouraged by the pilot data, and it moves us closer to making regenerative medicine a real and practical option for all veterinarians treating dogs suffering from OA.'.

“这是我们在革新狗类OA治疗方式方面迈出的又一积极步伐，”Gallant公司首席执行官琳达·布莱克博士（DVM，Ph.D.）说道。“初步数据让我们备受鼓舞，这使我们更接近于让再生医学成为所有治疗OA病犬的兽医们的现实且实用的选择。”

Gallant's free, RACE-approved continuing education platform, GallantU, provides veterinary professionals with practical education on regenerative medicine, including modules dedicated to canine OA. Sign up at learn.gallant.com and join the free upcoming webinar titled Canine Osteoarthritis: Current Concepts and Advancement in Management on May 13, 2026, at 7:00 p.m.

Gallant的免费RACE认证继续教育平台GallantU，为兽医专业人士提供关于再生医学的实用教育，其中包括专门针对犬骨关节炎（OA）的模块。请访问learn.gallant.com注册，并参加将于2026年5月13日晚上7:00举行的免费网络研讨会《犬骨关节炎：当前概念与管理进展》。

EDT. .

东部夏令时间。

For information on Gallant's Canine OA pilot study data, go to:

要了解 Gallant 的犬类 OA 试点研究数据，请访问：

https://bit.ly/4eR82Z0

https://bit.ly/4eR82Z0

About Gallant

关于加兰特

Gallant is an animal health biotechnology company creating a new category of veterinary care with a pipeline of off-the-shelf, ready-to-use stromal cell therapies targeting the root cause of disease in pets. Led by pioneers in veterinary regenerative medicine with deep expertise in development, manufacturing, and commercialization, Gallant is making regenerative medicine accessible — moving beyond symptom management to restoring health at the source.

Gallant是一家动物健康生物技术公司，通过一系列现成的、可直接使用的基质细胞疗法，开创了一种全新的兽医护理类别，针对宠物疾病的根源进行治疗。由兽医再生医学领域的先驱者领导，他们在研发、制造和商业化方面拥有深厚的专业知识，Gallant正让再生医学变得触手可及——超越症状管理，从源头恢复健康。

Learn more at .

了解更多，请访问。

www.gallant.com

www.gallant.com

.

。

Gallant's uterine-derived mesenchymal stromal cell therapy for canine osteoarthritis is an investigational new animal drug and has not received FDA approval or conditional approval. Availability is pending regulatory review.

Gallant的子宫源性间充质基质细胞疗法用于犬骨关节炎，是一种试验性的新动物药物，尚未获得FDA的批准或有条件批准。可用性有待监管审查。

Media Contact:

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Julie Lawless

朱莉·劳莱斯

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电子邮件地址

+1 615.585.5861

+1 615.585.5861

SOURCE Gallant

来源：Gallant

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