Esperion, at work on a cholesterol-lowering pill it hopes can disrupt some high-profile new injections, convinced the FDA to remove a partial clinical hold on the highest dose of its drug.
Amid all the fervor over cholesterol-fighting PCSK9 antibodies, Esperion Therapeutics is touting more positive results for a pill it hopes will play spoiler to those would-be-blockbuster injections.
A new generation of cardiovascular drugs has proved itself capable of lowering bad cholesterol across dozens of Phase III trials, but many physicians are holding out to see whether doing so can meaningfully improve patients' lives. In an early peek at some long-term data, one such injected therapy from Amgen halved the risk of major cardiovascular problems after one year of treatment, bolstering the case for the whole class of drugs.
Kevin Phillips, a researcher at Houston Methodist Research Institute, has already done research on the thyroid hormone receptor agonist GC-1 as it relates to reducing cholesterol. Now he says that higher doses offer a path to developing a new drug for weight loss.
Esperion Therapeutics has taken another big stride along the clinical path for its cholesterol drug. The biotech reports that its drug ETC-1002 slashed levels of the bad cholesterol LDL, particularly when it was combined with Merck's Zetia, in a Phase IIb trial. And now that the mid-stage program is complete, the Ann Arbor, MI-based biotech finds itself at the threshold of a late-stage program with a drug the company feels can thread the market needle between cheap generics and a looming wave of rival biologics.
Vitamin B-3, or niacin, is an essential human nutrient that has been used for more than 50 years to boost levels of HDL, or good cholesterol, in the blood. Now, new research suggests that a form of the vitamin might also be used to treat adult-onset mitochondrial muscle diseases.
The FDA tried to ease the concerns of drugmakers Thursday when it said that companies working on a new class of cholesterol-lowering drugs known as PCSK9 inhibitors, may not have to prove they also...
Tantalized by various megablockbuster projections for the PCSK9 field of cholesterol drugs, Pfizer has mapped out one of the most ambitious late-stage programs in the industry for RN-316.
Merck's experimental anacetrapib is one of those massively expensive lottery programs that can spur dreams of huge revenue streams.
Alnylam is pushing its latest RNAi drug through early clinical trials, highlighting the company's delivery platform that enables an effective gene-silencing treatment. This time, the RNA specialist published results from a successful Phase I study of its cholesterol drug ALN-PCS.