The Department of Defense has awarded Adaptive Phage Therapeutics a $10.2 million contract to help advance its experimental therapy for the treatment of multidrug-resistant infections.
Gaithersburg, MD-based Adaptive Phage Therapeutics (APT) says it will pursue a two-year multi-site clinical trial as it looks to get the OK from the FDA, which considers phage to be “Generally Regarded as Safe” and has identified phage therapy as a potential alternative to antibiotics.
Phages are bacterial viruses that destroy targeted bacteria—including those which have become resistant to antibiotics—and APT is developing its phage collection, “PhageBank,” to do just that.
According to the company, PhageBank is a library of polymicrobial broad-spectrum phages that can be matched to a specific pathogen. It is used with a companion diagnostic to select the best option for each patient.
“PhageBank incorporates a built-in feedback loop in which any uncovered bacteria are captured as source material for additional phage discovery. The additional phages enrich PhageBank and increase the spectrum of coverage, offering an effective response to evolving bacterial resistance,” explains APT CEO and co-founder Greg Merrill.
Since acquiring rights to PhageBank in 2017 from the US Navy, APT has provided patients access to the therapy under compassionate use.
Now, the company is working toward submitting the necessary data to the FDA in order to begin clinical trials in humans. If given the OK, APT plans to recruit patients with bacterial infections across three study sites in the US over the next 90 days. It will then quickly expand to a fourth site, Merrill tells Xconomy.
“Over the term of the program, APT’s effort is expected to expand terms of the variety of clinical indications and variety of pathogens,” he says. Though further details are undisclosed, the company says the market for the antibiotic alternative could be in excess of $4 billion for its first four planned indications.
“Phages have existed and co-evolved with bacteria over the past 3.8 billion years. There is a practically unlimited number of phages on earth,” he explains. And phages continue to evolve, which Merrill says enables “a broad and continually updated universe of potential options for patients with multi-drug resistant infections.”
The use of phage therapy to treat bacterial infections was first explored in the 1920s, Merrill says, though the emergence of antibiotics put development on the backburner. Today, as the threat of antibiotic resistance grows, however, so has the interest in phage therapy.
“Recent breakthroughs by APT and its collaborators at the biodefense directorate of the US military in bioinformatics, rapid phage-bacteria isolation and matching, and phage purification methods, enable both the rapid administration of phage therapy and a personalized solution tailored to a patient’s individual infection,” says Merrill.
APT in October last year raised approximately $7 million. Investors included Alexandria Venture Investments and an unnamed health care delivery network and New York Stock Exchange-listed life sciences company.