Bristol-Myers, Achillion, Idenix show progress with oral hepatitis C drugs

Bristol-Myers Squibb ($BMY) is staying in the chase to commercialize an all-oral regimen for hepatitis C, despite having to end development of one of its key weapons against the liver-damaging disease this summer because of serious adverse events in study patients.

Bristol is running against Gilead Sciences ($GILD), Abbott Labs ($ABT), Vertex Pharmaceuticals ($VRTX) and many others in a race to grab a share of a market for hep C drugs that is expected to skyrocket in future years as all-oral regimens become available to millions of patients with the chronic disease.

A mid-stage trial showed that 78% of hep C patients had a sustained virologic response 12 (SVR12) weeks after 24 weeks of treatment on Bristol's NS5A inhibitor daclatasvir and its NS3 protease inhibitor asunaprevir taken twice a day, the company reported over the weekend at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston. In a group of patients that got asunaprevir once a day, the SVR12 rate was a lower 65%. The patients in both groups had genotype 1b disease and previously failed treatment with interferon and ribavirin. 

"The high response rates seen in this study with daclatasvir and asunaprevir are encouraging as we seek interferon- and ribavirin-free hepatitis C regimens for this difficult-to-treat patient population," Dr. Brian Daniels, Bristol's senior vice president, global development and medical affairs, R&D, said in a statement.

Bristol removed a major item from its hep C agenda in August when the company axed development of a nucleotide polymerase inhibitor known as BMS-98609, after patients who took the drug suffered severe side effects and one death from heart failure. The drug was the prized asset from the company's $2.5 billion buyout of Inhibitex.

The drugmaker stressed that the mid-stage study of the daclatasvir and asunaprevir regimen showed no serious adverse events and none that caused any patients to drop out of the trial. About 4 of every 10 patients on the dual-antiviral regimen got headaches, the most common side effect reported in the study.

- see BMS' release

Achillion remains one of the closely watched players in hep C drug development

The New Haven, CT-based developer ($ACHN) announced at the AASLD congress that early-stage study data showed no drug-drug interaction in 24 healthy volunteers on a combination of its experimental compounds sovaprevir, an HCV protease inhibitor, and ACH-3102, an NS5A inhibitor. And no serious side effects were reported.

"We now plan to submit to the FDA a Phase 2 protocol that will evaluate an all-oral, interferon-free regimen containing sovaprevir and ACH-3102 for 12 weeks and, pending discussions with the regulatory agency, we intend to initiate this combination study with the goal of reporting rapid virologic response, or RVR, in the first half of 2013," Michael Kishbauch, president and CEO of Achillion, stated.

The company also revealed Phase I data from a short proof-of-concept study of its protease inhibitor, ACH-2684. It showed antiviral activity in patients both with and without previous exposure to treatments for their hep C.

Achillion has been one of the most discussed potential buyout targets for companies interested in beefing up their portfolios of oral hep C drugs, yet analysts have speculated that potential buyers might be waiting for further clinical data on its top drug candidates.

- here's Achillion's release

Idenix Pharmaceuticals is digging itself out from safety concerns about two of its drugs against hep C virus

Over the weekend, the Cambridge, MA-based company ($IDIX) presented at the AASLD meeting some of the data it plans to present to the FDA after the agency sidelined one of its "nuc" inhibitors in clinical development in reaction to the severe events that befell patients on Bristol's similar drug from Inhibitex.

The company looked back at a number of cardiovascular safety measurements from patients treated with IDX184, which the FDA placed on clinical hold in August, before the hold was put in place. Its analysis found no signs of severe cardiovascular side effects in patients treated with IDX184 along with interferon and ribavirin.

"The IDX184 presentation at AASLD details much of the key clinical data we intend to submit to the FDA in our response package by the end of the year," said Ron Renaud, Idenix's president and CEO, stated.

The hep C race is progressing rapidly, with large studies wrapping up in several months, and any delays in development programs can be costly.

- here's the company's release