Just a few months after the proposed marriage of Presidio Pharmaceuticals and BioCryst fell apart at the altar, Presidio has rebounded with a new hepatitis C collaboration with pharma powerhouse Boehringer Ingelheim.
Looking to open a new chapter, San Francisco-based Presidio will take the reins of a Phase IIa study that combines its NS5A inhibitor PPI-668 with Boehringer Ingelheim's HCV protease inhibitor faldaprevir (BI201335) and its non-nucleoside HCV polymerase inhibitor (BI207127), with or without ribavirin. The 12-week mid-stage study will launch in the next few months.
The goal here is to put a new, interferon-free cocktail to the proof-of-concept test. While Gilead Sciences ($GILD) is widely viewed as the leader in this race, with a full set of Phase III data at its back, AbbVie ($ABBV), Vertex Pharmaceuticals ($VRTX), Johnson & Johnson ($JNJ) and many other companies have been pursuing their own combo drugs, angling for a piece of a growing blockbuster market for hepatitis C. Current new therapies like Incivek have been losing ground recently as doctors and patients wait for new drugs that will skirt the harsh symptoms associated with interferon. And doctors will likely have a number of new cocktails to choose from in the near future.
"With the potent, complementary antiviral activities of PPI-668, faldaprevir, and BI207127, the present study focuses on patients with HCV genotype-1a infection, which has been harder to treat than HCV genotype-1b in many studies. The study will assess the potential of this three-drug oral regimen to achieve high rates of sustained viral clearance in hepatitis C patients, with good tolerance," said Dr. Nathaniel Brown, Presidio's CMO.
Last fall Presidio had agreed to a $101 million all-stock buyout deal with BioCryst. But then BioCryst's early-stage study of its NS5B inhibitor BCX5191 ran straight into a brick wall, undone by the FDA's concerns of toxicity. Then a late-stage study of peramivir failed and the FDA put a clinical hold on another program, making the merger untenable.
- here's the press release
Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold