8 recent reports on grants, approvals in clinical liver research

The FDA recently approved a thrombocytopenia therapy for adults with chronic liver disease and a combination therapy for advanced metastatic hepatocellular carcinoma. Along with these advancements, multiple societies have recently provided grants or investments into liver disease research.

The following reports include recent FDA approvals, grants, and orphan drug designations, as well as grant awards and investments into liver disease research such as the link between gut microbiota and alcoholic hepatitis, proof-of-concept fibrosis studies, and hepatitis D therapy.

Biocodex Microbiota Foundation awards grant to study gut microbiota, alcoholic hepatitis link

The Biocodex Microbiota Foundation recently awarded a grant of 200,000 euros to Bernd Schnabl, MD, a professor from University of California, San Diego, to advance research on the correlation between gut microbiota and alcoholic hepatitis, according to a press release.

“My lab is very interested in the interaction between the gut bacteria microbiome and liver disease,” Schnabl told Healio Gastroenterology and Liver Disease. “We had compared changes in the gut microbiome in certain liver diseases and saw the most dramatic changes in composition in preclinical models of alcoholic liver disease.” Read more

AASLD invests $4.06 million in liver disease research, development

The American Association for the Study of Liver Diseases Foundation announced its investment of $4.06 million in research and career development grants awarded to 36 researchers and clinicians, according to a press release.

This year’s award total is $715,00 more than the award total in 2017, making it the largest level of funding in the history of AASLD and AASLD Foundation. Read more

Pliant Therapeutics raises $62 million for proof-of-concept fibrosis studies

Pliant Therapeutics raised $62 million in a series B financing to support proof-of-concept clinical trials in idiopathic pulmonary fibrosis, primary sclerosing cholangitis, and other fibrotic diseases, according to a press release.

“We appreciate the vote of confidence of our respected biotech investors who join us in the pursuit of new medicines for patients with debilitating and deadly fibrotic diseases,” Bernard Coulie, MD, PhD, president and CEO of Pliant Therapeutics said in the release. “Our Series B financing will support the early development of our lead product candidate in idiopathic pulmonary fibrosis and primary sclerosing cholangitis, as well as our aggressive strategy to build our pipeline of proprietary product candidates and attract partnering opportunities.” Read more

FDA grants Tecentriq-Avastin combination breakthrough therapy designation for liver cancer

The FDA granted breakthrough therapy designation to atezolizumab in combination with bevacizumab as a first-line treatment for patients with advanced metastatic hepatocellular carcinoma.

The FDA based this designation on results from a phase 1b study that evaluated atezolizumab (Tecentriq, Genentech), an anti-PD-L1 therapy, and bevacizumab (Avastin, Genentech), an anti-VEGF therapy, among patients with hepatocellular carcinoma. Read more

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FDA approves Mulpleta for thrombocytopenia in adults with chronic liver disease

The FDA approved lusutrombopag for the treatment of thrombocytopenia among adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

The FDA based the approval of lusutrombopag (Mulpleta, Shionogi) on two randomized, double-blind trials that included 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure. All patients had a platelet count of less than 50 x 109/L. Read more

OBI Pharma receives FDA orphan drug designation for HCC therapy

OBI Pharma received FDA orphan drug designation for OBI-3424 for the treatment of hepatocellular carcinoma, according to a press release.

OBI-3424 is a first-in-class DNA alkylating cancer therapeutic designed to target aldo-keto reductase 1C3 overexpressing cancers. Read more

SomaGenics receives NIH grant to develop hepatitis D therapeutic

SomaGenics received a 3-year, $2.9 million award from the National Institutes of Health’s Small Business Innovation Research program to support development of the company’s RNA interference-based approach for hepatitis D, according to a press release.

The company’s HDV therapeutic was designed to simultaneously target the virus at multiple stages of its life cycle using proprietary synthetic short hairpin RNA technology. Read more

Eiger Biopharmaceuticals receives notice of allowance for hepatitis D treatment

Eiger BioPharmaceuticals received a notice of allowance from the U.S. Patent and Trademark Office for a patent claim on ritonavir-boosted lonafarnib for the treatment of hepatitis D, according to a press release.

“This method of use patent covers a range of ritonavir-boosted lonafarnib doses and durations, including specific doses that we anticipate will appear on the first label of lonafarnib for treatment of hepatitis delta virus infection,” David Cory, president and CEO of Eiger, said in the release. “This patent allowance is especially timely as we finalize the protocol for our single, pivotal registration study, D-LIVR, which we plan to initiate later this year.” Read more