Connect Biopharma Holding Ltd.’s IL-4Rα binding candidate, CBP-201, yielded positive data in a pivotal trial in patients with moderate to severe atopic dermatitis in China, positioning the company to engage with Chinese regulators in the next several months to discuss a potential NDA filing.
Paradigm Biopharmaceuticals Ltd. reported top-line data from its phase II trial of Zilosul (pentosan polysulfate/PPS) that suggest the non-opioid treatment for knee osteoarthritis is effective in navigating pain management but also has the potential to be disease modifying.
Analysts were upbeat about positive results from Eisai Co Ltd. and Biogen Inc.’s phase III confirmatory Clarity Alzheimer’s disease (AD) trial of lecanemab that met both primary and secondary endpoints, and most agreed that the data should be enough to gain FDA approval for mild cognitive impairment due to AD.
Polaris Pharmaceuticals Inc.’s pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of significant improvement in progression-free survival in patients enrolled in the pivotal phase II/III Atomic study in malignant pleural mesothelioma.
Top-line phase III results showing Hutchmed Ltd.’s targeted therapy fruquintinib reduced the risks of death and disease progression by 34% and 68%, respectively, for patients with metastatic colorectal cancer could “lay a solid foundation for Hutchmed to initiate discussions with regulatory authorities worldwide,” a spokesperson of Hutchmed, told BioWorld.
The May 2014 approval of Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) brought welcome news in the form of an important mechanism of action for patients with ulcerative colitis and Crohn’s disease, but also means a burdensome course of administration – 30 minutes’ worth of infusion every six weeks, a drawback that other developers are trying to remedy. Standouts among the up-and-comers are Morphic Holding Inc., with an oral candidate that works through the same mechanism of action as Entyvio, and Protagonist Therapeutics Inc.
An investigational drug developed in Cuba for the potential treatment of Alzheimer´s and Parkinson's diseases has moved forward to phase III trials there, where scientists are optimistic about results of previous studies. The candidate, named Neuroepo and branded Neuralcim, was developed by the Center of Molecular Immunology (also known by its Spanish acronym CIM), a state-owned lab in the Caribbean nation.
The bad news in March 2022 from Takeda Pharmaceutical Co. Ltd. regarding Natpara, its recombinant human parathyroid hormone for hypoparathyroidism (HPT), served to generate more interest in the already bubbling space, where a handful of players large and small own prospects at various clinical stages.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
The Project to Accelerate New Treatments for Tuberculosis is progressing two investigational tuberculosis combination treatment regimens into phase II trials under a joint development agreement.
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