The initial appraisal of the first complete genome sequence of a hantavirus isolated from a patient in Switzerland who was a passenger on the cruise ship MV Hondius is consistent with a spillover from its natural reservoir, rather than the emergence of a markedly altered virus. Comparisons of the Swiss genome with Andes hantavirus sequences from rodents and from previous human infection clusters “suggest that the Swiss patient isolate represents a relatively typical naturally-circulating Andes virus lineage originating from the established rodent reservoir in Chile/Argentina, rather than a highly diverged or newly emerged variant,” said Piet Maes, president-elect of the International Hantavirus Society and professor at the Plotkin Institute for Virology, Brussels, Belgium.
MBX highlights early data for monthly obesity candidate MBX-4291
Shares of MBX Biosciences Inc. hit a 52-week high on preliminary phase I data for its MBX-4291, a GLP-1/GIP co-agonist prodrug for obesity. Though early and still blinded, findings from the trial showed promising efficacy, along with good tolerability and the potential for once-monthly dosing, factors that will likely be critical for MBX to compete in the crowded obesity space. The results were reported by the company during its Obesity Day presentation, during which MBX also disclosed nomination of triple-agonist MBX-5765, also targeting obesity, and said it would halt further investment on long-acting GLP-1 antagonist imapextide (MBX-1416) in post-bariatric hypoglycemia.
Curacle, Memento ink $1B deal for ocular TIE2/VEGF bispecific
Curacle Co. Ltd. inked a potential $1.07 billion deal with U.S.-based “newco” Memento Medicines on May 10, granting the latter exclusive global rights to develop and commercialize preclinical TIE2/VEGF-directed bispecific antibody MT-103 for retinal disorders. Under the terms, Seoul, South Korea-based Curacle and strategic codeveloper Mabtics Co. Ltd. will receive $8 million up front from Memento, along with potential development, regulatory and commercialization milestone payments reaching up to $1.06 billion, plus additional undisclosed royalty payments. The proceeds will be split between Curacle and Mabtics on a 50-50 basis, according to the terms of their joint R&D agreement.
Bright Uro secures FDA approval for abdominal sensor
Bright Uro Inc. secured U.S. FDA 510(k) clearance for the Glean abdominal sensor, which expands the capabilities of its Glean urodynamics system to enable multi-channel urodynamic studies. The new sensor will allow clinicians to perform multi-channel urodynamics, capturing both abdominal and detrusor pressures without the need for catheters, supporting treatment decision-making for patients with lower urinary tract dysfunction and other urological conditions.
Alzheimer’s, beyond the brain
Researchers at Daping Hospital in China have reported that liver-targeted delivery of the APOE3-Christchurch (APOE3Ch) variant, a rare protective form of apolipoprotein E, can indirectly reduce brain pathology, highlighting the therapeutic potential of peripheral approaches to Alzheimer’s disease (AD). APOE4 stands out as the most potent common genetic risk factor for late-onset AD. Carrying a single copy substantially raises the likelihood of developing the condition, while inheriting two copies further amplifies risk and is associated with an earlier onset. Moreover, rather than being viewed solely as a risk factor, APOE4 homozygosity is increasingly being discussed as potentially representing a genetically defined form of AD.
FDA pregnancy safety guidance evolves with the science
Seven years after releasing a draft guidance on post-approval pregnancy safety studies, the U.S. FDA is now finalizing it – albeit with a few changes. In issuing the final guidance, the agency noted that pregnancy registries have been used to collect post-approval safety data, but scientific methodologies for assessing the safety of drugs and biologics used during pregnancy have evolved since the first guidance on the topic came out.