Close to two years ago Resverlogix ($RVX.TO) took a nasty hit when the company announced that its lead drug for atherosclerosis missed a primary endpoint and raised a troubling red flag on its safety profile in a mid-stage study. Today the biotech hoped to move past that setback once and for all, posting top-line Phase IIb results demonstrating a success on its primary endpoint for raising HDL while asserting that the spike in liver enzymes seen earlier was a transient event that did not threaten the program's future. And the CEO tells FierceBiotech this morning that a new $25 million loan will fund the company for the next two years as it heads into a pivotal study and pursues active partnering talks.
The data concerns RVX-208, an experimental therapeutic designed to scour plaque from hardening arteries, a major threat in an aging population. The study, which recruited 176 high-risk cardiovascular patients, determined that the drug heightened production of ApoA-I, a building block of the kind of high-density lipoprotein (HDL) particles that can scoop up plaque and flush it from the body, according to Resverlogix CEO Don McCaffrey.
Resverlogix has another trial underway to directly assess the drug's ability to clear atherosclerotic plaque which reads out in the first half of 2013. Its stock jumped about 15% this morning on the news.
In past scientific meetings, two CETP inhibitors--Merck's ($MRK) anacetrapib and Roche's ($RHHBY) dalcetrapib--had overshadowed RVX-208, McCaffrey acknowledges. Now dalcetrapib is dead and Resverlogix hopes to gain better recognition that its separate BET inhibitor approach on cardiovascular disease will distinguish RVX-208, which is designed to create empty HDL particles that can be used to package up unwanted plaque for disposal.
Now Resverlogix wants to capitalize on its epigenetic bromodomain research to strike discovery pacts with pharma outside of atherosclerosis and cap it all with a global pact on RVX-208 with a Big Pharma player. If the next study delivers solid evidence on plaque regression, says the CEO, "this will be the most sought-after drug program there is."
- read the press release on the data
- here's the release on the $25M loan
- get the report from Nature
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