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.

An­drew Vail­lant, Replicor

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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