In its bid to be one of the first biotechs to de­vel­op a drug for long Covid, which im­pacts as many as 1 in 4 el­der Amer­i­cans, Ax­cel­la said Thurs­day it has com­plet­ed en­roll­ment in a Phase IIa study look­ing at fa­tigue-re­lat­ed lin­ger­ing symp­toms of the pan­dem­ic dis­ease.

But the com­pa­ny will have to make progress with its long Covid and NASH mid-stage pro­grams with­out its pres­i­dent of R&D, Al­i­son Schecter. She stepped down im­me­di­ate­ly yes­ter­day to “pur­sue oth­er op­por­tu­ni­ties” af­ter 14 months with the Flag­ship-found­ed biotech, ac­cord­ing to an SEC fil­ing, and Ax­cel­la doesn’t cur­rent­ly have plans to re­place her, CEO Bill Hin­shaw told End­points News in an emailed state­ment.

The fo­cus on long Covid and NASH is al­so con­sum­ing most of Ax­cel­la’s re­sources. The biotech ter­mi­nat­ed a Phase II tri­al of a dif­fer­ent drug, AXA1665, in pa­tients with overt he­pat­ic en­cephalopa­thy, a com­pli­ca­tion of chron­ic liv­er dis­ease. Ax­cel­la will look for part­ners or new in­di­ca­tions to test the drug in, Hin­shaw said in a press re­lease.

Asked if the OHE tri­al ter­mi­na­tion will lead to lay­offs, Hin­shaw said: “Any avail­able re­sources will be uti­lized as we com­plete the Long COVID tri­al, pre­pare for a fol­low-on tri­al, and con­tin­ue to ex­e­cute on the NASH tri­al. ”

The 40-pa­tient, Ox­ford Uni­ver­si­ty-led long Covid tri­al is test­ing AXA1125, which is al­so in a Phase IIb study in NASH. Topline da­ta from the long Covid tri­al are planned for the “ear­ly” third quar­ter of this year and in­ter­im re­sults from the NASH study are slat­ed for lat­er that quar­ter.

“Achiev­ing com­ple­tion of en­roll­ment is a sig­nif­i­cant mile­stone in the de­vel­op­ment path of AXA1125 as a po­ten­tial treat­ment for Long Covid, a large and grow­ing con­se­quence of the glob­al pan­dem­ic,” said the com­pa­ny in a press re­lease.

The drug showed “key path­ways” in pre­clin­i­cal and clin­i­cal de­vel­op­ment in NASH stud­ies, which led the biotech to al­so test it as a po­ten­tial long Covid ther­a­peu­tic.

“So fat­ty acid ox­i­da­tion, basal res­pi­ra­tion, pref­er­en­tial ATP gen­er­a­tion, in­flam­ma­tion and oth­ers. And then we saw what was emerg­ing as the pan­dem­ic con­tin­ued to build, which was that one of the core dri­vers of long Covid was clear­ly mi­to­chon­dr­i­al dys­func­tion in those oth­er path­ways with­in that that I was speak­ing to,” CEO and pres­i­dent Bill Hin­shaw told End­points News in an in­ter­view last month.

Mar­garet Koziel

Right now, for the mil­lions of pa­tients with long Covid, the on­ly treat­ment op­tions are sup­port­ive care, CMO Mar­garet Koziel said in the joint in­ter­view with Hin­shaw.

“This is just stag­ger­ing in terms of its pub­lic health im­pact, and the abil­i­ty to get so­ci­ety back on its feet again, so we be­lieve that this is like­ly to be a com­plex phe­nom­e­non. We have ev­i­dence in the clin­ic of tar­get­ing mul­ti­ple rel­e­vant bi­o­log­ic path­ways and so we’re aim­ing to move as quick­ly as we can,” Koziel said.

If all pans out, Ax­cel­la could be one of the first drug de­vel­op­ers to get across the fin­ish line when it comes to treat­ing SARS-CoV-2’s long-term ef­fects on the body.

Paul Sekhri

“We’ve been hear­ing from the pa­tient com­mu­ni­ty about what the med­ical needs are and start­ing to think about how we would move this in­to a lat­er phase study, as­sum­ing that this pi­lot study is pos­i­tive,” Koziel said.

And the com­pa­ny’s board looks a lit­tle dif­fer­ent as of this week, ac­cord­ing to an SEC fil­ing.

Shree­r­am Arad­hye left the board on May 19 and, that same day, Ax­cel­la’s board ap­point­ed Paul Sekhri and Michael Rosen­blatt to join as Class II and Class I di­rec­tors, re­spec­tive­ly. Sekhri re­cent­ly stepped down as CEO of xeno­trans­plan­ta­tion biotech eGe­n­e­sis, and Rosen­blatt is a se­nior part­ner at Flag­ship Pi­o­neer­ing and for­mer Mer­ck CMO.

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

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.

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.