In an exclusive interview with The Fly, Axcella (AXLA) CEO Bill Hinshaw talked about the company, its pipeline, long COVID, the NASH opportunity and much more.

LONG COVID TRIAL: Axcella and Oxford University have started dosing long COVID patients in their Phase 2a clinical trial investigating AXA1125 as potential treatment for the debilitating symptoms of the disease. "The trial is going very well. We've initiated and started dosing patients. There is a tremendous interest both with patients as well with the medical community because unfortunately there are no proven options for patients with long COVID, there is very little in development and a tremendous need from a number standpoint – we now have 70M people globally estimated to have long COVID – fatigue is the most common symptom and has a huge impact both on society as they can't return to work and a human element," Axcella's CEO Bill Hinshaw explained to The Fly. " It's a very large need and thus we've had a tremendous response and we're on track to report our data in the middle of this year. We're extremely excited and compelled by this need. "

MILLIONS COULD POTENTIAL BENEFIT FROM AXA1125: COVID is here to stay near-term, at least, and while several vaccines have hit the market, there's still an unmet need in therapeutics, especially for long COVID. "The need is there so the opportunity to help people is there. Unfortunately, the numbers are quite staggering - an estimated of 70 million people with long COVID and that is growing dramatically with the increases we're seeing recently. Now, of those a majority suffers from fatigue. We're talking about over 35M worldwide. When you translate that into the United States, you're talking about more than 15M people with long COVID and more than 7.5M already suffering from some form of fatigue. We're testing this with the Phase 2a trial partnered with Oxford. We look at the middle of this year and hopefully we will provide a solution to these patients who are suffering and need help," the executive added.

EMMPACT TRIAL IN NASH: Discussing AXA1125's Phase 2b trial for non- alcoholic steatohepatitis, or NASH, Axcella's CEO said, "The Phase 2b EMMPACT trial is progressing very well." "We plan an interim analysis mid of this year and total data completion by second half of next year," the executive added. Hinshaw also noted that the NASH opportunity is "unfortunately very large." "Up to 40 million Americans are considered to have NASH. 1 in 10 of our children. And it has a devastating impact on the healthcare system. Consequentially, there is estimated to be a minimum of an $8B type of opportunity here and Axcella 1125's product is well positioned for first line and potential differentiation."

OVER HEPATIC ENCEPHALOPATHY: Axcella is also developing AXA1665 for overt hepatic encephalopathy. "This program is underway and screening patients actively. We've had high engagement from medical community because they understand that this product has the opportunity to first improve on the standard care and then become the standard care because of its multitargeted, well differentiated, safe and well tolerated profile. OHE is a rarer disease than NASH or long COVID, and we're working with the investigators to make sure we identify the right patients, screen against them and then treat them appropriately with the 1665 compared to the standard of care," the executive explained.

COVID-RELATED IMPACTS: Discussing any potential COVID-related impacts on the company's trials, Axcella's CEO said: "We've been fortunate, both in the initial stages of the pandemic where we completed our previous work as well as now, that we've been able to execute strongly in that context." "We have not to date seen any impact in the near-term from the pandemic on our sites outside what I would call normal in today's world. The sites have their protocols in place. Now, there's a possibility as always that as the pandemic evolves, there could be impact in our programs but today we haven't had supply chain issues and we will continue to monitor and collaborate with our groups to try to deliver against our timelines and right now we're on track for those," he added.

POISED FOR 'TRANSFORMATIONAL' YEAR: CEO Bill Hinshaw believes Axcella "is poised for a transformational year." "We have two major data readouts in long COVID and in 1125 with NASH.  These are very important diseases with high unmet needs. We are compelled and excited as a company. We believe we have high information, higher probability of success and a number of important transformational data readouts in the near-term," the executive told The Fly.

"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company. A more detailed version of this interview to follow.

For more on Axcella's trial in long COVID click here.
For more on Axcella's AXA1125 trial for NASH click here.
For more on Axcella's AXA1665 for overt hepatic encephalopathy click here.
For more on COVID-related impact click here.
For more on the company and upcoming events click here.