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Crystalys doses first patients in Phase II gout trial 

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Chronic gout

Crystalys Therapeutics has dosed the first patients in a Phase II trial evaluating a treatment for difficult-to-treat gout. 

The trial will evaluate dotinurad, a next-generation, once daily, oral URAT1 inhibitor with the potential to deliver best-in-class safety and efficacy for the treatment of gout, particularly in patients with limited treatment options. 

The study will consist of two consecutive parts: a 24-week placebo-controlled period where participants will take either dotinurad or placebo, followed by a 12-week active treatment period where all participants will take dotinurad. 

Gout is the most common form of inflammatory arthritis, characterised by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints. This disease arises from excess uric acid in the body, known as ‘hyperuricemia,’ which causes buildup of uric acid crystals and inflammation, which can lead to tophaceous gout in people with chronic or undertreated disease. 

“Dosing the first patient in our Phase II AMETHYST study marks an important milestone for Crystalys and for those living with gout who have limited treatment options,” said James Mackay, President and Chief Executive Officer of Crystalys Therapeutics.  

“This study builds on our broader clinical development programme, including the ongoing Phase III RUBY and TOPAZ trials, and reinforces our commitment to advancing comprehensive treatment options for patients with gout.” 

 

The post Crystalys doses first patients in Phase II gout trial  appeared first on Drug Discovery World (DDW).

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An obesity drug deep-dive, and peptides move mainstream

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Can any of the new obesity medications in development stand out from the pack? Which company just broke records with its IPO? And will the Food and Drug Administration allow greater access to experimental peptides?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

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RFK Jr. claims his calendar is publicly available. We’ve been trying to get it for a year

WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.

But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.

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WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.

But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.

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Nonprofit buys experimental cancer drug to maintain patient access

In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug.

As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, will also acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.

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In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug.

As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, will also acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.

Read the rest…

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