Gilead took a risky approach with selonsertib in NASH, pursuing a tough liver fibrosis benefit and failing, continuing a trend of disappointments outside of its antiviral franchises. Analysts don’t expect the second Phase III study in less-sick patients to succeed either.
The non-alcoholic steatohepatitis (NASH) drug-development race poses many variables, including which endpoint to pursue in pivotal studies. Gilead Sciences Inc. confirmed how challenging this can be by choosing to demonstrate a fibrosis benefit in very sick patients with its candidate selonsertib, which failed by this measure in a Phase III clinical trial.
What this means for the company's future chances in NASH and for other firms in the space remains unclear, but...
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.
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.
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.
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.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
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.
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