climbing rates of obesity and high blood pressure, more people are being diagnosed at a younger age.<\/a><\/p>\nIn the short term, doctors treat gout flares with strong anti-inflammatory drugs, like aspirin, ibuprofen and steroids.<\/p>\n
If the condition worsens, the main treatment for gout is allopurinol, a 60-year-old medication that is effective in only about half of gout patients \u2014 because it only addresses half of the problem, Mackay said.<\/p>\n
Allopurinol works by limiting the production of uric acid, but \u201cabout 85% of gout patients are sick because their kidneys can\u2019t excrete enough uric acid,\u201d said Mackay.<\/p>\n
Mackay believes Crystalys\u2019 new drug, dotinurad, has the potential to be effective in all patients because it treats the core of the problem \u2014 helping your body get rid of the uric acid, not just lowering its production.<\/p>\n
Before creating dotinurad, Mackay developed two other drugs that target gout. One was Zurampic, which was acquired by AstraZeneca for $1 billion but later taken off the market after safety concerns about serious kidney side effects.<\/p>\n
\u201cSometimes you get toxicity that was not necessarily predicted. And so everything in medicine is a balance of the potential risk versus the potential benefit,\u201d said Kavanaugh, when asked about Zurampic.<\/p>\n
Other gout treatments, like Takeda Pharmaceutical\u2019s febuxostat, brand name Uloric, received the highest warning label from the FDA, also known as a black-box label, for high cardiovascular complications, including death.<\/p>\n
Now it\u2019s discontinued. According to FDA records, Takeda ceased Uloric distribution in March.<\/p>\n
Crystalys\u2019 drug works differently. The small-molecule drug, taken orally, blocks URAT1, a protein that reabsorbs uric acid in the kidney, to help patients excrete the uric acid in their urine.<\/p>\n
The new medication doesn\u2019t have the toxicity liability his first drug, Zurampic, had, Mackay said. \u201cIt\u2019s also 1,000 times more potent than the original molecule that we worked on,\u201d he said.<\/p>\n
Dotinurad was originally developed by Japanese company Fuji Yakuhin. The drug received regulatory approval in its home country in 2020. Today, the drug is commercially available in Japan, China, Taiwan, the Philippines and Thailand.<\/p>\n
The Japanese company that discovered the drug sold the rights to Florida-based Urica Therapeutics. Crystalys then licensed the drug from Urica.<\/p>\n
\u201cUrica Therapeutics does hold an equity position in Crystalys Therapeutics and has a seat on the Crystalys Therapeutics board,\u201d said Mackay.<\/p>\n
Crystalys holds exclusive license rights for dotinurad in North America, Europe, Middle East and North Africa territories. The deal terms consist of low single-digit development milestones, low double-digit sales-related payments and double-digit tiered sales royalties, he said.<\/p>\n
\u201cOver 2.2 million patients have received the drug,\u201d Mackay said. \u201cSo it has a very large and stable safety database.\u201d<\/p>\n
Mackay brought the data back to U.S. investors and decided to bring it through clinical trials stateside.<\/p>\n
Given its success abroad, the FDA is allowing Crystalys to skip Phase 2 testing.<\/p>\n
The FDA\u2019s one requirement is some dose-ranging data within the Phase 3 program, so one of the trials will test both a 2 mg and a 4 mg dose. Across the studies, Crystalys is targeting enrollment of about 750 patients total. Mackay expects results in late 2027.<\/p>\n
\u201cIt\u2019s personal for me,\u201d said Mackay. \u201cThere\u2019s no better feeling than getting approval for a drug that you know is then going to help millions of patients.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"As a child, James Mackay watched his father struggle just to stand up. \u201cYou shouldn\u2019t have eaten this…\n","protected":false},"author":3,"featured_media":965908,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[5134],"tags":[5229,3653,64,1582,276,210,1370,50,3549,7264,7289,67,586,132,5230,68,2969],"class_list":["post-965907","post","type-post","status-publish","format-standard","has-post-thumbnail","category-san-diego","tag-america","tag-biotech","tag-business","tag-ca","tag-california","tag-health","tag-latest-headlines","tag-news","tag-san-diego","tag-sandiego","tag-top-stories-sdut","tag-united-states","tag-united-states-of-america","tag-unitedstates","tag-unitedstatesofamerica","tag-us","tag-usa"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/117001055568205495","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/965907","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=965907"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/965907\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/965908"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=965907"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=965907"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=965907"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}