HONG KONG – Galmed Pharmaceuticals Ltd. has struck an agreement with Ascletis Pharma Inc.’s Gannex arm to develop a combination therapy comprising Ascletis’ ASC-41 and Galmed’s Aramchol (arachidyl amido cholanoic acid) for nonalcoholic steatohepatitis (NASH).
In a deal that could bring the company as much as $1.04 billion, Arrowhead Pharmaceuticals Inc. will collaborate with Takeda Pharmaceutical Co. Ltd. to co-develop and co-commercialize an investigational RNAi-based liver disease treatment. Arrowhead’s candidate, ARO-AAT, is designed to reduce mutant alpha-1 antitrypsin protein production, which causes the disease to progress. Arrowhead will receive a $300 million up-front payment on closing in addition to development, regulatory and commercial milestones that could total $740 million.
Synthetic Biologics Inc. said a phase IIb trial of one of its two lead candidates, SYN-010, in people with constipation-predominant irritable bowel syndrome (IBS-C) will be discontinued after an interim futility analysis suggested it was unlikely to meet the study's primary endpoint.
Ironwood Pharmaceuticals Inc. CEO Mark Mallon said the company will seek to grow Linzess (linaclotide) and “continue to scan the environment” for more prospects in gastrointestinal conditions after the phase III fizzle in one of two identical experiments with IW-3718 in refractory gastroesophageal reflux disease.
The positive interim 24-week liver biopsy results from Arrowhead Pharmaceuticals Inc.’s open-label phase II of its RNAi-based liver-targeted therapeutic, ARO-AAT, came as a surprise to the developers.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), drug-induced liver injury (DILI) is the leading cause of acute liver failure in the U.S. It is also a leading cause of drug failure in clinical trials. Now, researchers have used liver organoids to develop a polygenic risk score that could predict the risk of liver toxicity for multiple different drugs, regardless of the underlying mechanism.
Good news from a pivotal phase III trial of Albireo Pharma Inc.'s odevixibat has moved the world one step closer to going from no treatments for the rare genetic liver disease PFIC to possibly having two: Albireo's entrant and another candidate, maralixibat from Mirum Pharmaceuticals Inc.
Updated results from a phase II test of Viking Therapeutics Inc.'s VK-2809 in people with nonalcoholic fatty liver disease (NAFLD) and elevated LDL-cholesterol found it delivered durable reductions in liver fat even four weeks post-treatment.
LONDON – Engitix Ltd has secured Takeda Pharmaceutical Co. Ltd.’s endorsement of its extracellular matrix (ECM) technology in a potential $500 million deal in liver fibrosis.
HONG KONG –Celltrion Group is partnering with Intract Pharma Ltd. to jointly develop an oral tablet form of infliximab. “Celltrion will supply the drug material through clinical evaluation and into the market, while Intract will be responsible for performing clinical studies,” Bill Lindsay, the CEO of Intract, told BioWorld.
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