{"id":202973,"date":"2023-11-29T19:33:43","date_gmt":"2023-11-29T14:03:43","guid":{"rendered":"https:\/\/dripp.zone\/news\/?p=202973"},"modified":"2023-11-29T19:33:43","modified_gmt":"2023-11-29T14:03:43","slug":"all-dogs-can-go-to-heaven-later-fda-advances-longevity-drug-for-big-dogs-crypto-news","status":"publish","type":"post","link":"https:\/\/dripp.zone\/news\/all-dogs-can-go-to-heaven-later-fda-advances-longevity-drug-for-big-dogs-crypto-news\/","title":{"rendered":"All Dogs Can Go to Heaven\u2014Later: FDA Advances Longevity Drug for Big Dogs &#8211; Crypto News"},"content":{"rendered":"<div style=\"position:relative;overflow:visible;font-size:1.2em;line-height:1.58\">\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">Animal health biotech startup <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/loyalfordogs.com\/\" class=\"sc-adb616fe-0 iLQIVg\">Loyal<\/a> is a step closer to being able to market a drug for lifespan extension in dogs, the company <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.businesswire.com\/news\/home\/20231127326868\/en\/5561513\/FDA-Agrees-Loyal-Data-Supports-Reasonable-Expectation-of-Effectiveness-for-Large-Dog-Lifespan-Extension\" class=\"sc-adb616fe-0 iLQIVg\">said<\/a> on Tuesday.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">The U.S. Food and Drug Administration\u2019s Center for Veterinary Medicine has approved the \u201cReasonable Expectation of Effectiveness\u201d section of Loyal\u2019s application to sell a new large- dog-focused drug called LOY-001.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">\u201cFour years ago I founded Loyal with a simple vision \u2014 to bring to market the first drug explicitly approved and labeled for healthy lifespan extension,\u201d Loyal founder and CEO Celine Halioua wrote in a <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/loyalfordogs.com\/posts\/loyal-announces-historic-fda-milestone-for-large-dog-lifespan-extension-drug\" class=\"sc-adb616fe-0 iLQIVg\">blog post<\/a>. \u201cLoyal was only a few months old and about five people when we decided to begin by targeting the abnormally short lifespan of large breed dogs with a drug program we code-named LOY-001.\u201d<\/p>\n<div class=\"relative w-full\">\n<blockquote class=\"twitter-tweet mx-auto\">\n<p lang=\"en\" dir=\"ltr\">1 &#8211; Loyal has earned what we believe is the FDA\u2019s first-ever formal acceptance that a drug can be developed + approved for lifespan extension<\/p>\n<p>2 &#8211; We have &#8216;technical section complete&#8217; AKA the &#8216;does it work&#8217; data for LOY-001 &#8211; our large dog lifespan extension drug &#8211; is done<\/p>\n<p>\u2014 Celine Halioua (@celinehalioua) <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/twitter.com\/celinehalioua\/status\/1729525718827274642?ref_src=twsrc%5Etfw\" data-wpel-link=\"internal\">November 28, 2023<\/a><\/p>\n<\/blockquote>\n<\/div>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">LOY-001 aims to extend the lifespan and quality of life in large and giant breed dogs, which may have as little as half the expected lifespan of small breeds, Loyal explained, noting Great Danes and Newfoundlands may live only eight years, compared to 20 years for Chihuahuas and Miniature Poodles.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">The drug reduces <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/en.wikipedia.org\/wiki\/Insulin-like_growth_factor_1#:~:text=IGF-1%20is%20a%20protein%20that%20in%20humans%20is,is%20the%20primary%20cause%20of%20the%20toy%20phenotype.\" class=\"sc-adb616fe-0 iLQIVg\">Insulin-like Growth Factor 1<\/a> (IGF-1,) a hormone associated with growth and development in dogs that the company said is 28x more prevalent in large dogs than small dogs.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">But Loyal&#8217;s vision extends far beyond man&#8217;s best friend.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">&#8220;Dogs first to extend human lifespan,&#8221; Halioua wrote on Twitter. &#8220;Save the dogs, save the world!&#8221;<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">&#8220;As there is no regulatory path for a lifespan extension drug, we had to design from scratch a scientifically strong and logistically feasible way to demonstrate [the] efficacy of an aging drug,&#8221; she explained.\u00a0&#8220;This took over four years, resulting in the 2,300+ page technical section approved today.&#8221;<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">&#8220;I&#8217;m proud, still a bit shocked, and kind of feel like the dog that caught the mailman and doesn&#8217;t know what to do now,&#8221; Halioua continued. Fortunately, the FDA process is meticulous and strict.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">For the LOY-001 canine drug, the next step would be to obtain FDA approval for Loyal\u2019s manufacturing and safety data packages. After getting final FDA approval, Loyal said the drug could be available in 2026. Typically, FDA <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.drugs.com\/fda-approval-process.html\" class=\"sc-adb616fe-0 iLQIVg\">approval<\/a> for a human drug can take up to fifteen years, delaying availability.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">\u201cToday\u2019s milestone is a crucial part of Loyal\u2019s application for conditional approval,\u201d the company said in a <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.businesswire.com\/news\/home\/20231127326868\/en\/FDA-Agrees-Loyal-Data-Supports-Reasonable-Expectation-of-Effectiveness-for-Large-Dog-Lifespan-Extension\" class=\"sc-adb616fe-0 iLQIVg\">statement<\/a>. \u201cIt means the FDA agrees LOY-001 has a reasonable expectation of effectiveness.\u201d<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">Launched in 2019 by Celine Halioua, San Francisco-based Loyal is a clinical-stage veterinary medicine company focused on extending the health and lifespan of dogs. In September 2021, Loyal announced the raise of $27 million in Series A funding led by Khosla Ventures. Other investors included First Round Capital, Box Group, Collaborative Fund, The Longevity Fund, and Lachy Groom, according to a 2021 Techcrunch <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/techcrunch.com\/2021\/09\/23\/loyal-raises-27m-aims-to-give-dog-owners-more-time-with-their-pets\/\" class=\"sc-adb616fe-0 iLQIVg\">report<\/a>.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">\u201cEver 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,\u201d Khosla Ventures Founder Vinod Khosla said. \u201cToday\u2019s announcement marks a first for any longevity drug, and is a big step towards accelerating the path for canines, and ultimately humans.\u201d<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">Loyal confirmed to <i>Decrypt<\/i> that the LOY-001 drug itself has not yet been submitted. Instead, LOY-001 was introduced through the FDA\u2019s <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.fda.gov\/animal-veterinary\/resources-you\/conditional-approval-explained-resource-veterinarians\" class=\"sc-adb616fe-0 iLQIVg\">Expanded Conditional Approval<\/a> process, which gives the FDA authority to approve certain drugs meant for \u201cminor species\u201d like fish, ferrets, and dogs.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">According to the company\u2019s <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/loyalfordogs.com\/products\" class=\"sc-adb616fe-0 iLQIVg\">website<\/a>, the next drug, LOY-002, will be launched for older dogs of all but the smallest breeds in early 2025. Loyal said the company is conducting clinical trials for LOY-002 for dogs ten years and older that weigh at least 14 pounds.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">While humans may consider <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/decrypt.co\/198980\/longevity-starts-with-ending-self-destructive-behavior-anti-aging-billionaire-bryan-johnson\" class=\"sc-adb616fe-0 iLQIVg\">longevity<\/a> medicine a potential fountain of youth, Loyal said LOY-001 is meant to not only extend the lives of dogs but also to correct centuries of human-driven dog breeding.<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\">\u201cThe extreme phenotypic variety found in dogs is not \u2018natural\u2019 \u2014 it\u2019s the result of intensive breeding by humans to create dogs that excelled at tasks such as herding, protection, and companionship,\u201d Loyal\u2019s Director of Veterinary Medicine Brennen McKenzie said. \u201cAt 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.\u201d<\/p>\n<p class=\"font-meta-serif-pro scene:font-noto-sans scene:text-base scene:md:text-lg font-normal text-lg md:text-xl md:leading-9 tracking-px text-body gg-dark:text-neutral-100\"><i>Edited by <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/decrypt.co\/author\/ryanozawa\" class=\"sc-adb616fe-0 iLQIVg\">Ryan Ozawa<\/a>.<\/i><\/p>\n<div class=\"my-4 border-b border-decryptGridline\">\n<div class=\"text-start p-8 md:py-12 md:px-12 max-w-prose relative\"><span class=\"border-t-4 border-l-4 w-4 h-4 md:border-t-[6px] md:border-l-[6px] md:w-6 md:h-6 border-decryptPurple dark:border-decryptNeon gg-dark:border-cc-pink-2 absolute top-4 left-4 md:top-6 md:left-6\" \/><span class=\"border-t-4 border-l-4 w-4 h-4 md:border-t-[6px] md:border-l-[6px] md:w-6 md:h-6 border-decryptPurple dark:border-decryptNeon gg-dark:border-cc-pink-2 absolute rotate-180 bottom-4 right-4 md:bottom-6 md:right-6\" \/><\/p>\n<h3 class=\"font-akzidenz-grotesk font-bold text-xl md:text-3xl mb-6 md:text-center gg-dark:text-white\">Stay on top of crypto news, get daily updates in your inbox.<\/h3>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Animal health biotech startup Loyal is a step closer to being able to market a drug for lifespan extension in dogs, the company said on Tuesday. The U.S. Food and Drug Administration\u2019s Center for Veterinary Medicine has approved the \u201cReasonable Expectation of Effectiveness\u201d section of Loyal\u2019s application to sell a new large- dog-focused drug called [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":202974,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[230,225,221,227,226,228,229,60,223,224,222],"class_list":["post-202973","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cryptocurrency","tag-brave","tag-coinbase","tag-crypto","tag-decentralised","tag-decentralized","tag-decentralized-exchange","tag-erc-20","tag-featured","tag-meme-coin","tag-robinhood","tag-solana"],"_links":{"self":[{"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/posts\/202973","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/comments?post=202973"}],"version-history":[{"count":2,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/posts\/202973\/revisions"}],"predecessor-version":[{"id":202980,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/posts\/202973\/revisions\/202980"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/media\/202974"}],"wp:attachment":[{"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/media?parent=202973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/categories?post=202973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dripp.zone\/news\/wp-json\/wp\/v2\/tags?post=202973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}