Following a data-cleaning delay and mixed results in Alzheimer’s disease, Annovis Bio Inc. reported phase III Parkinson’s disease data showing treatment with buntanetap stops cognitive decline and improves motor and other functions, including postural instability and gait difficulty, meeting all primary and secondary endpoints.
On the heels of an AU$100 million (US$66.5 million) capital raise, Immutep Ltd. announced positive top-line results in first-line head and neck cancer with its lead candidate, eftilagimod, in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab).
Just seven months after in-licensing ocedurenone (KBP-5074) from KBP Biosciences Pte. Ltd. in a $1.3 billion deal, Novo Nordisk A/S halted its late-stage study after ocedurenone failed to significantly control hypertension in chronic kidney disease patients.
In May 2024, BioWorld covered 298 updates across phase I-III clinical trials, surpassing March (261), February (236) and January (252), though falling short of April’s high of 323. Additionally, at the end of May BioWorld revised its reporting criteria for clinical trial updates, focusing mainly on data readouts and excluding trial initiations, enrollment changes and initial patient dosing, thereby impacting the update count relative to prior months.
The obesity market is hot with Novo Nordisk A/S generating $6.3 billion in sales from its semaglutide-containing drugs, Ozempic, Saxenda, Rybelsus and Wegovy, in the first quarter of 2024 and Eli Lilly and Co. bringing in $2.3 billion for its tirzepatide-containing drugs, Zepbound and Mounjaro, in the same quarter. It appears unlikely the market will be a two-horse race for much longer though.
Positive top-line results from Calcimedica Inc.’s placebo-controlled phase IIb of Auxora in acute pancreatitis couldn’t support the stock for the day. The selective small-molecule inhibitor of Orai1-containing calcium release-activated calcium (CRAC) channels hit the randomized, double-blind, dose-ranging Carpo study’s primary endpoint, the median time it took to tolerate solid food, as patients who received Auxora had a statistically significant dose response compared to those who received placebo.
The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.
A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial.
After a previous phase III failure, Savara Inc. kept at it and found success with molgramostim for the rare lung disease autoimmune pulmonary alveolar proteinosis. A second attempt, the pivotal phase III Impala-2 study of molgramostim, an inhaled form of recombinant granulocyte macrophage colony-stimulating factor for adults, hit its primary endpoint and left participants breathing easier. The results led Savara to say it would complete a BLA submission sometime in the first half of 2025, with filings in Europe and Japan to follow.
Continuous glucose monitors continue to post positive results for managing diabetes in an ever-expanding population. Long a mainstay of disease management for those with type 1 diabetes, the devices have also proved themselves in treating type 2 diabetes that requires multiple daily injections of insulin.
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