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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Through the agreement, Hillstream aims to acquire a clinical stage asset, AV104 (nalmefene), an opioid antagonist, but first it intends to seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis with primary biliary cholangitis.
GB1211 demonstrated improvement and consistent signs of activity across biochemical liver function markers and markers of target engagement, apoptosis, and fibrosis, including reductions in galectin-3 (p<0.05) and CK-18 (M65) (p<0.002).
GB1211 is an orally available and potent small molecule galectin-3 inhibitor. Galecto’s initial target indications for GB1211 are liver cirrhosis, a severe, progressive disease that ultimately leads to liver failure, and non-small cell lung cancer.
CNP-104 uses COUR's proprietary nanoparticle platform (CNP), a novel system which combines disease specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying liver cells from the body.
Lead Product(s):
Nanoparticle Encapsulating PDC-E2
This agreement gives Ironwood an option to acquire an exclusive license to develop and commercialize, in the U.S., COUR’s investigational therapy CNP-104 (the “License”), which if successful, could transform the treatment of Primary Biliary Cholangitis.
Lead Product(s):
Nanoparticle Encapsulating PDC-E2
New analyses of the Phase 1b/2a study data showed BIO89-100 treatment resulted in significant reductions in liver volume of up to 15% and liver fat volume of up to 65% in treated patients at 13 weeks compared to baseline, as measured by MRI-PDFF.
Similar reductions in liver fat, ALT and triglycerides between biopsy-confirmed NASH and PNASH patients treated with BIO89-100 and their similar baseline characteristics underscored the consistency across these two sub-populations of patients enrolled in the trial.
Clinical data from its Phase 1b/2a study evaluating BIO89-100, a long-acting glycoPEGylated FGF21 analog, in patients with nonalcoholic steatohepatitis (NASH) will be presented in a late-breaking poster at The Liver Meeting Digital Experience™ 2020 of the AASLD.
Company plans to share topline safety, tolerability and efficacy data from its Phase 1b/2a study of BIO89-100 in NASH in a pre-market press release and webcast.
89bio intends to use the net proceeds of the offering to accelerate and support its BIO89-100 programs in nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG), for the manufacture and scale up of BIO89-100, and for other general corporate purposes.
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