Ultragenyx Data De-Risk Phase III Trial Of Setrusumab

 
• By Joseph Haas
  
Generate a summary of this article
Listen to this article
Beta

The Mereo-partnered drug is in pivotal development for osteogenesis imperfecta. Ultragenyx also recently reported positive Phase III data for a rare disease gene therapy.

Bone health
Ultragenyx's 14-month data for setrusumab shows sustained reduction of fractures • Source: Shutterstock

Ultragenyx Pharmaceutical Inc. unveiled positive 14-month data on 11 June from the Phase II portion of a potentially registrational trial of setrusumab in osteogenesis imperfecta (OI), which multiple analysts said will de-risk the drug’s chances of succeeding in the trial’s Phase III portion. Interim Phase III readouts for the drug, partnered with UK-based Mereo BioPharma Group plc, are expected in late 2024 or early-to-mid 2025.

Key Takeaways

  • Ultragenyx updated six-month data for its osteogenesis imperfecta candidate setrusumab with 14-month data from a Phase II/III study that demonstrated sustained reduction in annualized fracture rate.

It was the second positive data readout for Ultragenyx in the past two weeks, following the 30 May disclosure of...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Clinical Trials

Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

 
• By Xu Hu

Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

 
• By Xu Hu

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Sponsored By:

Nancy Tests SPARC-931-part

The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D

Scrip-R&D-Premium: ‘Article’ article that includes different Composer content

 
• By Nabil, Olga Zviezdicheva, Reed Miller, Mary Jo Laffler, Ian Schofield, João Andrés-Ruíz de la Fontaine-LeBlanc, Chloë Anastasía-Stojanović del Castillo-Ribeirão, and Nabil

To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.