Bill Hinshaw, Axcella CEO

UP­DAT­ED: Say­ing good­bye to R&D chief, Flag­ship-backed Ax­cel­la drops PhII pro­gram as it fo­cus­es on long Covid, NASH

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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

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.

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

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.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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