
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.

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.

“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.