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

Posted under Blog, cholesterol drug, Companies, Diagnostics, Funding, Karo Bio, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

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

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Pfizer R&D pact could inject $217M into Karo Bio

Posted under autoimmune disease, Blog, Companies, Diagnostics, Funding, Karo Bio, Medical Devices, Medical Supply, multiple sclerosis, Pfizer, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Swedish biotech Karo Bio's ($KARO) shares spiked after the company revealed a new research and development deal focused on autoimmune diseases with U.S. drug giant Pfizer ($PFE). Karo, which has been planning cutbacks and a spin-off, could reap as much as $217 million in upfront and milestone fees, in addition to royalties, from Pfizer, the company announced Dec. 24.

Karo's shares surged 80% after the announcement, the biggest jump since the stock hit the public market in 1998, Bloomberg reported. The upbeat news came amid upheaval at the Huddinge, Sweden-based company, which announced 25 staff cuts Nov. 1, about a week after revealing plans to spin off its preclinical business and reduce expenses.

The Pfizer deal centers on Karo's small molecule RORgamma (RORgt) modulators against autoimmune diseases such as multiple sclerosis, rheumatoid arthritis and psoriasis, according to Karo's release. Pfizer will provide all of the funding for the collaboration and get exclusive worldwide market rights to drugs developed under the agreement. Karo said it's already discovered drugs targeting the nuclear hormone receptor RORgamma, which triggers the production of an inflammation-causing protein called IL-17. The protein is the progeny of T helper 17 cells, or Th17s, which are key players in numerous immune-related diseases.

"The central role of RORgt in Th17 cell differentiation coupled with the increasing clinical validation for the importance of IL-17 and other Th17-derived cytokines in autoimmune diseases, makes RORgt a compelling target," Jose-Carlos Gutierrez-Ramos, Pfizer's senior vice president, biotherapeutics, worldwide R&D, said in a statement. "Combining KaroBio's deep expertise in nuclear hormone receptors with the world-class chemistry and cytokine immunology expertise of Pfizer has the potential to accelerate our drug discovery effort in this competitive area."

A bevy of drug companies are now involved in research of drugs targeting Th17-related pathways. The big ones include GlaxoSmithKline ($GSK), Biogen Idec ($BIIB) and Merck ($MRK), and startups including GSK-backed Tempero Pharmaceuticals and Merck partner Lycera have been active as well.

- here's the release
- see Bloomberg's article

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