While Regulus was getting dinged this morning following some careful scrutiny of its latest hep C data, Achillion came out on top with new trial results which demonstrated that a combination of its NS5A inhibitor and Gilead's Sovaldi triggered a 6-week cure among all of the patients in a small study. And now researchers are using the data to set the stage to see if the results can be replicated even faster in a 4-week trial.
Investigators found that 50 mg of ACH-3102 and 400 mg of sofosbuvir did the trick for 12 out of 12 treatment-naive genotype 1 patients. CEO Milind Deshpande touted the results as the shortest duration, highest response results yet seen. He added: "Given the exceptional profile of ACH-3102, we will now be evaluating four- and six-week treatment durations that leverage all of our HCV assets including ACH-3102, ACH-3422, and sovaprevir."
Shares of New Haven, CT-based Achillion ($ACHN) were up 12% after the news hit Monday morning.
Achillion is still looking to enter a fast-crowding marketplace. Competing drugs from Gilead and AbbVie have forced out earlier standard remedies with oral combos that are much easier to tolerate and much more likely to provide a lasting cure. The goal now is to find ways to do it quicker and with less expense, providing an opening for some of the companies still in the hunt.
"The ability to further shorten treatment duration to only six weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase 2 results support that goal. The profile of ACH-3102, represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV," commented Professor Edward Gane, the lead investigator in the study.
Achillion had to deal with a clinical hold earlier, which chilled once red-hot rumors of a potential takeover. The hold, though, was lifted ahead of early-stage data released last year, and Merck helped to reignite the speculation of a possible takeover after paying $3.9 billion for the rival Idenix. Currently drugs are available for 8 and 12-week regimens and payers are happy to see more drugs in the pipeline as they look to leverage ever lower prices for these drugs.
Few biotechs loved to flirt with investors about the prospect of a buyout more than the hepatitis C specialist Achillion. Former CEO Michael Kishbauch made a habit of it. And not long after Deshpande took the helm, he quickly reignited talk of a sale, only to watch the stock tank days later when the FDA put its NS3/4A protease inhibitor, sovaprevir, on clinical hold.
- here's the release