Positive early stage data for Verve Therapeutics Inc.’s base editing therapy points to a range of development options, including bringing partner Eli Lilly and Co. in a little closer. Verve’s Heart-2 phase Ib of VERVE-102 in treating 14 patients with heterozygous familial hypercholesterolemia and/or premature coronary artery disease showed one infusion led to dose-dependent decreases in blood PCSK9 protein levels and low density lipoprotein cholesterol. Verve has an agreement with Lilly to develop the PCSK9 program. Lilly could opt in during the second half of 2025 to share 33% of the global development expenses. The company’s stock (NASDAQ:VERV) had jumped 18% at midday to $3.85 per share.

Pfizer’s loss offers boost to competitors in obesity space

Pfizer Inc. is ending work on oral GLP-1 candidate danuglipron for weight loss following the report of a single potentially drug-induced liver injury, a move that appears to open the door for other firms working on oral therapies in the high-dollar obesity space, even as industry watchers seek further details to determine whether similar safety signals could emerge for those competitors.

Ironwood plunges on need for another apraglutide study

Shares of Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) were trading at 61 cents, down 33 cents, or 35%, on an unfavorable regulatory update. The Boston-based company said that, based on recent talks with the U.S. FDA, a confirmatory phase III trial is needed to seek approval of apraglutide for patients with short bowel syndrome who have intestinal failure and are dependent on parenteral support. Apraglutide is designed to mimic the effects of GLP-2. Work will continue with the compound, but Ironwood has engaged Goldman Sachs & Co. LLC to explore strategic alternatives.

UK aims for ‘faster, fairer and more inclusive’ clinical trials

As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework. The analysis of all initial applications received by the Medicines and Healthcare products Agency (MHRA) between February 2019 and October 2023 also will inform the implementation of the new rules and sets the baseline from which to increase the number and the diversity of clinical studies in the future. The aim is to ensure clinical trials are “faster, fairer and more inclusive,” said Andrea Manfrin, MHRA deputy director of clinical investigations and trials. “This analysis shows clearly where the U.K. is leading and where we need to work with our stakeholders to go further,” he said.

Australian researchers discover new compound to treat long COVID

Researchers have developed a new compound that can prevent long COVID symptoms in mice that could lead to a future drug for the debilitating condition in humans. Developed by researchers at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia, the world-first study found mice treated with the antiviral compound were protected from long-term brain and lung dysfunction, which are key symptoms of long COVID. As previously reported by BioWorld, there are an estimated 400 million individuals with long COVID globally. In the U.S. that number is estimated to be 18 million, or 6% of the population. “We developed this drug based on a lot of different compounds, and it started very early in the pandemic,” first author Stefanie Bader told BioWorld. The goal was to find a drug that inhibits replication, so the virus doesn’t spread.

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