Adaptive Phage Therapeutics just landed a game-changing allowance from regulators.
The Maryland biotech said Wednesday the Food and Drug Administration has cleared its expanded access investigational new drug application for its therapy for antibiotic-resistant bacteria in Covid-19 patients.
The green light means the company can treat coronavirus patients infected with certain types of bacteria that cause pneumonia, as well as bacteremia or septicemia — bacteria in the bloodstream.
“The FDA’s decision supports our ability to provide a new treatment option for critically ill Covid-19 patients with bacterial infections resistant to nearly all other available therapies,” Subhendu Basu, chief operating officer of Adaptive Phage, said in a statement. “This Covid-19 patient population is rapidly increasing in line with the overall number of hospitalized Covid-19 patients. As a result, APT expects requests for PhageBank therapy to address this critical unmet need to continue to increase in the coming months.”
The Gaithersburg company plans to request a meeting with the agency once it has more data “to raise the possibility” of an emergency use authorization in this patient population, Basu said.
Adaptive Phage has thus far administered its PhageBank therapy to nine Texas patients with secondary infections from Covid-19.
The company is making the therapy free to patients. It’s now seeking financial support from federal agencies and private-sector organizations to continue providing this access.
“Without such funding, our ability to meet the growing demand to treat antibiotic-resistant secondary bacterial infections in the ever-increasing U.S. Covid-19 population remains uncertain,” APT CEO and co-founder Greg Merril said in a statement. “We are hopeful that our ongoing discussions with a variety of government and nongovernmental bodies will result in our ability to continue to meet this urgent medical need in our country.”
The news comes after the Gaithersburg biotech separately earned orphan drug designation from the FDA for its treatment in prosthetic joint infections.
The Montgomery County biotech is also planning to open a $30 million Series B round this year to fuel expansion of its clinical pipeline. It is first raising $7 million in new funding with the Mayo Clinic as its lead investor.
The company — which Merril launched with his father in 2016 out of National Institutes of Health research in collaboration with the Navy — has raised $38 million to date, including a previous $7 million round and a $10.2 million contract with the Department of Defense. APT is also hiring and expanding its existing space in Gaithersburg, following a $9.8 million DOD contract for research and development of Covid-19 vaccine candidates using its phage-based approach.
