GSK, new­ly brand­ed and soon-to-be de­merged, shared in­ter­im re­sults from its Phase II tri­al on its chron­ic he­pati­tis B treat­ment, one that it says has the “po­ten­tial to lead to a func­tion­al cure.”

At a pre­sen­ta­tion at the EASL In­ter­na­tion­al Liv­er Con­gress, GSK shared that in around 450 pa­tients who re­ceived its hep B drug bepirovirsen for 24 weeks, just un­der 30% had he­pati­tis B sur­face anti­gen and vi­ral DNA lev­els that were too low to de­tect.

No­tably, pa­tients who were tak­ing nu­cle­o­side analogs (the cur­rent stan­dard of care treat­ment) along­side bepirovirsen and those who were not had sim­i­lar out­comes.

Chris Cor­si­co

To put that in­to per­spec­tive, pa­tients with chron­ic he­pati­tis B of­ten have to take nu­cle­o­side analogs, which sup­press he­pati­tis B virus (HBV) ex­pres­sion, through­out their life­time. Alone, nu­cle­o­side analogs have a func­tion­al cure rate that hov­ers around 1-5%, and in com­bi­na­tion with in­ter­fer­on treat­ment, that num­ber jumps a lit­tle high­er.

To be con­sid­ered a func­tion­al cure, the virus has to be sti­fled enough that the im­mune sys­tem can con­trol it on its own, GSK’s head of de­vel­op­ment Chris Cor­si­co told End­points News.

“If we were able … to — us­ing monother­a­py for 24 weeks and then stop­ping ther­a­py — get any­thing close to the in­ter­fer­on plus nu­cle­o­side/nu­cleotide stan­dard of care, that would be ab­solute­ly a phe­nom­e­nal re­sult,” Cor­si­co said.

The big ques­tion now is dura­bil­i­ty. And with­out that da­ta in hand yet, Cor­si­co said he can’t call GSK’s treat­ment a func­tion­al cure, though he said their cur­rent num­bers were ex­cit­ing for “the long-term prospects.”

How­ev­er, Cor­si­co al­so said he “rec­og­nized [there is] a large group of pa­tients who need fur­ther ther­a­py.” On that end, GSK is ex­plor­ing tri­als to put bepirovirsen in com­bi­na­tion with an in­ter­fer­on treat­ment as well as with its he­pati­tis B im­munother­a­py, ac­cord­ing to a press re­lease.

Cor­si­co not­ed that more in­sight on who the treat­ment was and wasn’t work­ing for would be com­ing lat­er. “One of the pur­pos­es of this study was to col­lect a whole bunch of bio­mark­ers to see if we could then start us­ing that da­ta to help us pre­dict who was re­spond­ing and who was not re­spond­ing,” he said, adding that GSK wouldn’t have that da­ta un­til the end of the tri­al.

Around 1% of pa­tients had treat­ment-re­lat­ed se­ri­ous ad­verse events, and Cor­si­co not­ed that a few of those cas­es were re­lat­ed to the in­jec­tion site.

GSK li­censed bepirovirsen from Io­n­is in 2019. The drug is a sin­gle strand of syn­thet­ic nu­cleotides that com­ple­ment HBV RNA and re­cruit liv­er en­zymes to de­stroy it.

Else­where in the he­pati­tis B space, the FDA slapped a clin­i­cal hold on An­tios’ Phase II tri­al in May, lead­ing to part­ner As­sem­bly Bio­sciences ditch­ing the duo’s he­pati­tis B col­lab­o­ra­tion.

GSK’s fi­nal study re­sults, which in­clude two oth­er treat­ment arms with dif­fer­ent dosage sched­ules, will be pre­sent­ed to­wards the end of the year, Cor­si­co said.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.