A small, largely unknown biotech in Canada is reporting some remarkable results from a tiny proof-of-concept study for a new hep B combo.
Reporting at the American Association for the Study of Liver Disease meeting in Washington, DC, investigators for the Montreal-based Replicor say that they tracked a persistent functional cure for 4 of the handful of patients being treated with a combination therapy. And 8 of 10 patients have achieved what they term “functional control” over the disease.
The combo matches an in-house drug dubbed REP 2139 with tenofovir disoproxil fumarate and pegylated interferon alpha 2a. Without the proprietary drug, the researchers say that patients can expect a 10% response. And they’re now setting the stage for a bigger trial to put their drug to a more ambitious test.
Their definition of functional control was the reduction of hepatitis B surface antigens to less than one IU/mL and viral DNA levels of less than 10 IU/mL. This was an open-label study with no control arm.
Not much has been reported about this private biotech company, including any details on how it’s been financed since it was founded in 2009.
Replicor CSO Andrew Vaillant had this to say in a prepared statement:
The addition of REP 2139’s unique ability to clear circulating HBsAg improves this outcome in a striking fashion, achieving functional control in 80% of patients not only during treatment but persisting after treatment is withdrawn. Equally important is the normalization of liver function during follow-up in all these patients, even those with significantly elevated liver enzymes at the start of therapy.
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