Will Ultragenyx/Kyowa Hypophosphatemia Data Support Uptake?

Ultragenyx and partner Kyowa Hakko Kirin said burosumab (KRN23) met the primary endpoint regarding phosphate levels in a Phase III study that enrolled adult X-linked hypophosphatemia patients, but small effects on two out of three secondary endpoints could impact the product's use.

chemist

Burosumab (KRN23) from Ultragenyx Pharmaceutical Inc. and Kyowa Hakko Kirin Co. Ltd. met the primary endpoint of an increase in serum phosphorous levels in a Phase III clinical trial testing the biologic in adults with X-linked hypophosphatemia (XLH), but the limited effect on certain secondary endpoints could reduce the product candidate's use in the rare bone-destroying disease.

Ultragenyx believes that burosumab's effects on three measures that impact XLH patients' quality of life will improve beyond the 24-week...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By 

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

GSK, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

 
• By 

GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut

Pfizer’s Hympavzi Poised For Broader Hemophilia Label

 

The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.

Vor Is Reborn With New CEO And Ambitious RemeGen Autoimmune Pact

 
• By 

The biotech had been looking at options to survive since May.

More from R&D

Vor Is Reborn With New CEO And Ambitious RemeGen Autoimmune Pact

 
• By 

The biotech had been looking at options to survive since May.

Biogen’s Spinraza Follow-On May Offer Disease-Modifying Potential

 
• By 

Biogen hopes to move directly from Phase I to Phase III with salanersen, a higher-potency therapy that uses the same mechanism of action as Spinraza.

Nuvalent Believes Safety Profile Can Help Zidesamtinib Be ROS-1 Lung Cancer Leader

 

Zidesamtinib would be the fifth ROS-1 targeting therapy on the market, but Nuvalent believes its safety and efficacy profile will make it the best in class.