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.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.