Ionis Confident In Wainua Expansion Strategy Despite Alnylam Trial Changes

Amvuttra and Wainua Are Rivals In The Space

Investors are closely following a Phase III study testing Wainua in ATTR cardiomyopathy, which could read out early in 2025.

runners
Ionis and Alnylam are competing in cardiomyopathy • Source: Shutterstock

Ionis Pharmaceuticals, Inc. CEO Brett Monia said the company remains confident in the Phase III trial design for Wainua (eplontersen) for the treatment of hereditary transthyretin mediated amyloidosis (ATTR) cardiomyopathy, days after rival Alnylam Pharmaceuticals Inc. made changes to the endpoint and timeline of an ongoing Phase III trial testing Amvuttra (vutrisiran) for the same indication.

Key Takeaways

  • Ionis responded to investor questions about the Phase III development program for Wainua in ATTR cardiomyopathy, after Alnylam announced changes to the study of a rival drug.

Alnylam’s announcement on 15 February during the company’s fourth quarter sales and earnings call startled some investors, as the Phase...

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.

More from Clinical Trials

Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

 
• By 

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 

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 

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.