Michael LaCroix-Fralish

Assessing whether or not a candidate drug increases lifespan in animals requires a great deal of planning and control. Any number of external factors can result in spurious results in a longevity study that can take 3+ years to perform. The best study is one that is carefully standardized to minimize these external factors

The Interventions Testing Program (ITP) is the standard in controlled longevity studies

The National Institute on Aging (NIA) is a division of the United States National Institutes of Health (NIH). Founded in 1974, the 

 is a national center of leadership and expertise on biology of aging research; In order to standardize the process of testing compounds for pro-longevity properties, the NIA has established the The Interventions Testing Program (ITP).

The ITP program uses a rigorous protocol to test compounds across three separate research institutions (University of Michigan, the Jackson Laboratories, and the University of Texas Health Sciences Center at San Antonio) using the same type of mice to ensure that the findings are robust and reproducible. [1] Over the past 17 years, the ITP has proven to be the gold standard by which potential pro-longevity compounds are evaluated, having identified seven new compounds that significantly increase lifespan in mice. A detailed introduction to the strategy behind the ITP can be found in paper by Warner, et al. [2]

ITP projects are nominated by external investigators and are rigorously vetted by a team of esteemed experts in the aging research field for the potential to extend lifespan and delay disease and dysfunction in mice. Only compounds backed by the strongest scientific ideas get approval to join the ITP program.

Due to this rigorous vetting process, the ITP has historically accepted only four or five new interventions for investigation each year.

For the 2021 cohort, we are proud to announce that two Loyal-sponsored compound proposals were accepted for the ITP program.

Loyal is committed to contributing to the fundamental biological understanding of aging and investigating novel targets for improving lifespan and healthspan. The selected compounds that our team nominated this year will help the aging research field to better understand two new targets/mechanisms that have the potential to significantly increase healthy lifespan.

Through this research collaboration with the NIA ITP we continue to make significant progress in our mission of identifying novel approaches to improve the healthy lives of dogs. We are excited by the opportunity to work with the exceptional scientists at the ITP to test these important new ideas.

Two Loyal-nominated compounds selected for the National Institute on Aging Interventions Testing Program

Assessing whether or not a candidate drug increases lifespan in animals requires a great deal of planning and control. Any number of external factors can result in spurious results in a longevity study that can take 3+ years to perform. The best study is one that is carefully standardized to minimize these external factors







The Interventions Testing Program (ITP) is the standard in controlled longevity studies







The National Institute on Aging (NIA) is a division of the United States National Institutes of Health (NIH). Founded in 1974, the <a href="https://www.nia.nih.gov/" target="_blank" rel="noreferrer noopener">NIA</a> is a national center of leadership and expertise on biology of aging research; In order to standardize the process of testing compounds for pro-longevity properties, the NIA has established the The Interventions Testing Program (ITP).



The ITP program uses a rigorous protocol to test compounds across three separate research institutions (University of Michigan, the Jackson Laboratories, and the University of Texas Health Sciences Center at San Antonio) using the same type of mice to ensure that the findings are robust and reproducible. [1] Over the past 17 years, the ITP has proven to be the gold standard by which potential pro-longevity compounds are evaluated, having identified seven new compounds that significantly increase lifespan in mice. A detailed introduction to the strategy behind the ITP can be found in paper by Warner, et al. [2]



ITP projects are nominated by external investigators and are rigorously vetted by a team of esteemed experts in the aging research field for the potential to extend lifespan and delay disease and dysfunction in mice. Only compounds backed by the strongest scientific ideas get approval to join the ITP program.



Due to this rigorous vetting process, the ITP has historically accepted only four or five new interventions for investigation each year.







<h2 class="wp-block-heading">For the 2021 cohort, we are proud to announce that two Loyal-sponsored compound proposals were accepted for the ITP program.</h2>



Loyal is committed to contributing to the fundamental biological understanding of aging and investigating novel targets for improving lifespan and healthspan. The selected compounds that our team nominated this year will help the aging research field to better understand two new targets/mechanisms that have the potential to significantly increase healthy lifespan.



Through this research collaboration with the NIA ITP we continue to make significant progress in our mission of identifying novel approaches to improve the healthy lives of dogs. We are excited by the opportunity to work with the exceptional scientists at the ITP to test these important new ideas.



<ol class="wp-block-list">
<li><a href="https://www.nia.nih.gov/research/dab/interventions-testing-program-itp" target="_blank" rel="noreferrer noopener">https://www.nia.nih.gov/research/dab/interventions-testing-program-itp</a></li>



<li>Mechanisms of Ageing and Development, 115: 199–207, 2000</li>
</ol>

Celine Halioua

I’m excited to share that Blake Scholl, the Founder and CEO of 

, has joined our Board of Directors as our first Independent Director.

Blake’s deep expertise in building and scaling a successful, mission-driven business within a highly regulated industry will be both instructive and valuable for Loyal as we grow. 

Loyal hit a number of key milestones over the last twelve months for LOY001 (an implant for large dog lifespan extension) and LOY002 (a daily, tasty pill for old dog lifespan extension):

We are running towards hopeful FDA approval of our drug programs, and being able to support veterinarians and pet parents in helping their dogs live longer, healthier lives.

Blake’s operational, commercial, and technical expertise brings immense benefit as we build towards bringing the first dog aging drugs to market.  

We’re delighted he’s joining our Board.

Blake Scholl joins the Loyal Board of Directors

I’m excited to share that Blake Scholl, the Founder and CEO of <a href="https://boomsupersonic.com/">Boom Supersonic</a>, has joined our Board of Directors as our first Independent Director.



Blake’s deep expertise in building and scaling a successful, mission-driven business within a highly regulated industry will be both instructive and valuable for Loyal as we grow.&nbsp;



Loyal hit a number of key milestones over the last twelve months for LOY001 (an implant for large dog lifespan extension) and LOY002 (a daily, tasty pill for old dog lifespan extension):



<ul class="wp-block-list"><li>We dosed the first companion dog — Josie, a seven-year-old Mastiff — with one of our aging drugs.</li><li>We manufactured prototypes of LOY001 and LOY002.</li><li>We successfully completed the canine aging efficacy data for our two current drug programs, and submitted the LOY001 efficacy package to the FDA.</li><li>We have over 50 veterinary practices interested in participating in our clinical study of LOY002.</li></ul>



We are running towards hopeful FDA approval of our drug programs, and being able to support veterinarians and pet parents in helping their dogs live longer, healthier lives.



Blake’s operational, commercial, and technical expertise brings immense benefit as we build towards bringing the first dog aging drugs to market.&nbsp;&nbsp;



We’re delighted he’s joining our Board.

Karen Greenwood

Some important news: Loyal has received protocol concurrence from the FDA on our companion dog longevity study. This means that the FDA has reviewed the scientific design of our study and determined that it meets their high quality standards, and will validate whether our drug extends canine lifespan and 

In other words, if our study demonstrates that our dog longevity drug extends healthy lifespan, those results will be sufficient to support bringing the drug to market for dogs across the country. 

_________________________________________

Our concurrence means we fundamentally agree with your proposed design, execution, and analyses…

This is a huge milestone for any drug company, but it’s especially significant because, to our knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and healthspan, rather than only proving efficacy against a single, specific disease — which is the case with most drugs on the market today.

Loyal was founded around the audacious idea that we should have drugs explicitly designed and FDA-approved to extend general healthy lifespan. With this milestone we take another big step in the direction of this vision. 

To achieve this milestone, we worked with scientists and statisticians at the 

 CVM— the division of the FDA responsible for overseeing the medicines we give our pets — to interrogate and optimize our study design.

We and the CVM have a shared interest in making sure our study is designed in a way that proves whether our products are effective and safe; both are paramount, scientifically and ethically.

Protocol concurrence is a huge step, but it’s not a guarantee

While we’re energized by this milestone, there’s still a lot of hard and careful work to be done.

Clinical trials are complex, and although we strive always to make scientific, evidence-based decisions in our study design and treatments, we won’t actually know how a drug will perform at scale in the real world until we run the study.

What looks promising and effective in a laboratory must in turn be proven in the field — the real world, where dogs live alongside us, and under the supervision of veterinarians in a clinical setting. This is the purpose of clinical trials.

If the study doesn’t deliver a positive outcome, we won’t — and shouldn’t — get approval. 

Designing a study to prove lifespan extension

Clinical studies are sometimes straightforward and sometimes complex. A study to show whether a new flea and tick treatment works can take much less time to design and conduct, since there are many previous studies showing how to measure the efficacy of these drugs.

Ours has been a much longer process — a total of 553 days, just over 18 months, from first discussion on the program to protocol concurrence.

We believe we’re the first to design and receive FDA concurrence for a clinical study that measures lifespan extension following treatment of the underlying causes of aging, rather than any specific disease.

We’re actively recruiting veterinary practices across the country to run clinical trials later this year. If you’re interested in partnering with us on this groundbreaking study, get in touch with our veterinary team today.

We often are asked why we aren’t working on dog aging supplements.

At Loyal we made the decision from the start that we would seek FDA approval for our aging drugs. It’s a rigorous, expensive, years-long process that sets a very high bar for both safety and efficacy — exactly as it should be.

Supplements have no such obligation, and even if they do run their own studies, there’s no oversight. This is why you’ll see a “These statements have not been evaluated by the FDA” disclaimer in fine print on supplements for dogs and humans alike.

While supplements may not hurt and might help your dog, there’s no process to regulate or validate the claims they make on their label, so you can’t be sure of a supplement’s safety or effectiveness.

And for us, especially when our dogs are involved, that just isn’t good enough.

Be the first to know when we’re recruiting dogs for our study

Karen is Loyal’s Senior Vice President of Regulatory & Strategy, and brings more than three decades of animal pharmaceutical experience to the company. She spent 27 years in 

 before going on to oversee programs at leading animal pharmaceutical companies including 

Loyal’s latest milestone: the first longevity clinical study design supported by the FDA

Some important news: Loyal has received protocol concurrence from the FDA on our companion dog longevity study. This means that the FDA has reviewed the scientific design of our study and determined that it meets their high quality standards, and will validate whether our drug extends canine lifespan and <a href="https://blog-admin.loyalfordogs.com/how-scientists-measure-aging-through-healthspan-frailty-and-quality-of-life/" data-type="URL" data-id="https://blog-admin.loyalfordogs.com/how-scientists-measure-aging-through-healthspan-frailty-and-quality-of-life/">healthspan</a>.



In other words, if our study demonstrates that our dog longevity drug extends healthy lifespan, those results will be sufficient to support bringing the drug to market for dogs across the country. 



_________________________________________



<h2 class="wp-block-heading has-text-align-center has-regular-font-size">Our concurrence means we fundamentally agree with your proposed design, execution, and analyses…</h2>



– FDA CENTER FOR VETERINARY MEDICINE



_________________________________________



This is a huge milestone for any drug company, but it’s especially significant because, to our knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and healthspan, rather than only proving efficacy against a single, specific disease — which is the case with most drugs on the market today.



Loyal was founded around the audacious idea that we should have drugs explicitly designed and FDA-approved to extend general healthy lifespan. With this milestone we take another big step in the direction of this vision.&nbsp;



To achieve this milestone, we worked with scientists and statisticians at the <a href="https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine" data-type="URL" data-id="https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine">Center for Veterinary Medicine</a> CVM— the division of the FDA responsible for overseeing the medicines we give our pets — to interrogate and optimize our study design.



We and the CVM have a shared interest in making sure our study is designed in a way that proves whether our products are effective and safe; both are paramount, scientifically and ethically.











<h2 class="wp-block-heading has-large-font-size" id="protocol-concurrence-is-a-huge-step-but-it-s-not-a-guarantee" style="font-style:normal;font-weight:600">Protocol concurrence is a huge step, but it’s not a guarantee</h2>



While we’re energized by this milestone, there’s still a lot of hard and careful work to be done.



Clinical trials are complex, and although we strive always to make scientific, evidence-based decisions in our study design and treatments, we won’t actually know how a drug will perform at scale in the real world until we run the study.



What looks promising and effective in a laboratory must in turn be proven in the field — the real world, where dogs live alongside us, and under the supervision of veterinarians in a clinical setting. This is the purpose of clinical trials.



If the study doesn’t deliver a positive outcome, we won’t — and shouldn’t — get approval.&nbsp;











<h2 class="wp-block-heading has-large-font-size" id="designing-a-study-to-prove-lifespan-extension" style="font-style:normal;font-weight:600">Designing a study to prove lifespan extension</h2>



Clinical studies are sometimes straightforward and sometimes complex. A study to show whether a new flea and tick treatment works can take much less time to design and conduct, since there are many previous studies showing how to measure the efficacy of these drugs.



Ours has been a much longer process —&nbsp;a total of 553 days, just over 18 months, from first discussion on the program to protocol concurrence.



We believe we’re the first to design and receive FDA concurrence for a clinical study that measures lifespan extension following treatment of the underlying causes of aging, rather than any specific disease.



We’re actively recruiting veterinary practices across the country to run clinical trials later this year. If you’re interested in partnering with us on this groundbreaking study, get in touch with our veterinary team today.



→ <a href="https://loyalfordogs.com/for-vets/">Become a clinical trial site</a>











<h2 class="wp-block-heading has-large-font-size" id="why-fda-approval-is-so-important" style="font-style:normal;font-weight:600">Why FDA approval is so important</h2>



We often are asked why we aren’t working on dog aging supplements.



At Loyal we made the decision from the start that we would seek FDA approval for our aging drugs. It’s a rigorous, expensive, years-long process that sets a very high bar for both safety and efficacy — exactly as it should be.



Supplements have no such obligation, and even if they do run their own studies, there’s no oversight. This is why you’ll see a “These statements have not been evaluated by the FDA” disclaimer in fine print on supplements for dogs and humans alike.



While supplements may not hurt and might help your dog, there’s no process to regulate or validate the claims they make on their label, so you can’t be sure of a supplement&#8217;s safety or effectiveness.



And for us, especially when our dogs are involved, that just isn’t good enough.











<h2 class="wp-block-heading has-large-font-size" id="be-the-first-to-know-when-we-re-recruiting-dogs-for-our-study" style="font-style:normal;font-weight:600">Be the first to know when we’re recruiting dogs for our study </h2>



<h2 class="wp-block-heading has-large-font-size" id="be-the-first-to-know-when-we-re-recruiting-dogs-for-our-study" style="font-style:normal;font-weight:600">→ <a href="https://loyalfordogs.com/#join">Join our list today</a></h2>







<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="683" src="http://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-1024x683.jpg" alt="" class="wp-image-735" style="width:695px;height:464px" srcset="https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-1024x683.jpg 1024w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-300x200.jpg 300w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-768x512.jpg 768w, https://blog-admin.loyalfordogs.com/wp-content/uploads/2023/03/DSC02606-1536x1024.jpg 1536w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



Karen is Loyal’s Senior Vice President of Regulatory &amp; Strategy, and brings more than three decades of animal pharmaceutical experience to the company. She spent 27 years in <a href="https://www.pfizer.com/content/animal-health" data-type="URL" data-id="https://www.pfizer.com/content/animal-health">Pfizer’s Animal Health</a> group and <a href="https://www.zoetis.com/" data-type="URL" data-id="https://www.zoetis.com/">Zoetis</a> before going on to oversee programs at leading animal pharmaceutical companies including <a href="https://parnell.com/" data-type="URL" data-id="https://parnell.com/">Parnell</a> and <a href="https://ir.kindredbio.com/" data-type="URL" data-id="https://ir.kindredbio.com/">KindredBio</a>.