Drug Development

UPDATED: J&J advances through PhII with a promising hep C triple and 100% cure rate

Curing hepatitis C is a done deal now. But J&J is stepping through the clinic with a new combo that the pharma giant hopes will prove it can do it all faster, and presumably cheaper, than what’s available now.

Achillion CEO Milind Deshpande

Achillion CEO Milind Deshpande

In a new batch of data put out Friday morning by J&J partner Achillion $ACHN, J&J’s team scored a 100% cure rate in three cohorts of patients getting a triple combination of odalasvir, AL-335 and Olysio (simeprevir). A fourth cohort that excluded simeprevir achieved a 90% cure rate at SVR12, 12 weeks after treatment. And one of the triplet cohorts achieved 100% cure for 20 patients after just 6 weeks of treatment.

That last figure could be crucial, says Baird’s Brian Skorney:

Success at six weeks has the potential to make this regimen a serious competitor to Gilead’s regimens, which cure in eight to 12 weeks.

The Phase IIa results fixed the dose that J&J $JNJ will use in the next step, a Phase IIb that will enroll both treatment-naive and treatment-experienced non-cirrhotic patients chronically infected with hepatitis C virus which runs the slate of genotypes 1, 2, 4, 5, and 6. Investigators will also expand the IIa to include a broader mix of patients as they push ahead toward pivotal studies and what looks like a probable approval.

Gilead, as we know, changed the treatment standard with its breakthrough hep C drugs, beginning with Sovaldi and continuing with Harvoni. Gilead also has a triple in the works, and has a reputation as a tough competitor in any market it plays in. Gilead’s success was also followed up by new combos from Merck and AbbVie, which further complicate the arrival of any new therapies. While wholesale prices have been dropping, putting Gilead past the peak revenue stage, J&J still sees some big commercial upside in a world where millions of these slow-burning cases have yet to be diagnosed.

That strategy drove a deal to license in Achillion’s NS5A drug odalasvir (ACH-3102) in a $1.1 billion pact. The pharma giant also bought out Alios for $1.75 billion, gaining the nucleotide NS5B inhibitor AL-335, which was added to a portfolio that also included the NS3/4A protease inhibitor Olysio.

It’s not all good news for the hep C team, though. Jefferies’ Brian Abrahams was quick to note that there are still unanswered questions on how this second-wave rivalry will play out, and whether J&J can successfully carve out a piece of the market. And he noted:

Based on two viral rebounds observed in the 8 week dual NS5A arm, we have confirmed that ACHN/JNJ will no longer pursue a dual-regimen — slightly disappointing, given results of the pilot “proxy” odalasvir-sofosbuvir study, which had shown 100% SVRs with an odalasvir containing dual-regimen with both 8- and even 6-week treatment durations, and could have been a differentiating feature. (We speculate this may be due to either AL-335 being less potent than sofosbuvir, or to odalasvir dosing/exposure still being optimized). The 6 week triple-regimen showed promising 100% EoT suppression, and given JNJ’s plan to explore a 6 week regimen in ph.IIb, we believe SVR data available at the meeting in 2 weeks could look promising and indicate a potential future path for the cocktail.

Noted Achillion CEO Milind Deshpande:

“Based on these interim results, Janssen plans to advance a phase 2b program for the triple combination to further understand the potential of this 3DAA drug combination to shorten the duration of treatment for patients suffering from HCV. Despite recent therapeutic advances, we believe there remains a significant unmet need in addressing the global burden of hepatitis C virus in those living with the disease.”

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