Karo Bio walks away from Phase III cholesterol drug due to safety risks

Struggling biotech Karo Bio has nixed its lead program for the anti-cholesterol drug eprotirome and canceled plans to split the Swedish developer into two companies, one of which would have focused on advancing eprotirome. And the company's top brass are now trying to highlight their early-stage work and research of drugs that target nuclear receptors.

Eprotirome proved too unsafe despite its cholesterol-lowering effects seen in earlier trials. A toxicology study involving dogs showed that animals on both high and low doses of the drug suffered cartilage damage after 12 months of exposure, while animals in the control did not experience the same side effects. The results were damaging enough for the company to pull the plug on the program, which had cost Karo Bio about $15 million (SEK 100 million) through 2011.

"Eprotirome has been a project with great potential, but also a project with risks," Karo Bio CEO Per Bengtsson said in a statement. "Unfortunately, the [benefits do not outweigh the risks associated with long term use, which is] why we are forced to make this difficult decision."

Without the eprotirome program, Bengtsson now has to excite investors about the prospects of the company's other projects and collaboration with drug giant Pfizer ($PFE), which agreed to fund research of the biotech's research of drugs that target the RORgamma pathway to fight autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. But the clock is ticking: Karo Bio has enough cash now to keep its operations afloat for at least 12 months, the company said. The biotech has already undertaken staff cuts and other measures to conserve cash.  

- here's the release