- Arranta Bio, a contract manufacturer formed last year to help companies produce microbiome therapies, has finished building manufacturing suites at a site in Watertown, Massachusetts.
- The company is pouring more than $100 million into the commercial-ready facility, which will supply developers with live biotherapeutic products. An Arranta plant in Gainesville, Florida, is also being expanded to address demand for early clinical supply.
- The investment comes as the field of research into the human microbiome, the trillions of microbes that colonize our bodies, has made some notable progress. Multiple developers have reported positive results from clinical trials this year, and one of them, Seres Therapeutics, could seek a regulatory clearance in 2021.
Arranta is a relative newcomer to the field of microbiome therapeutics, through which drugmakers aim to harness the bacteria that live in our bodies to treat tricky conditions.
But Arranata, which was formed in 2019, appears to have joined the fray at the right time.
Some 200 companies are working on microbiome-related therapies, according to Arranta. And the giant contract manufacturer Lonza, which has a joint venture focused on microbiome drugs, estimated the market for supplying live biotherapeutic products could top $200 million within five years.
Investment in microbiome research has been building for years, despite some notable clinical setbacks. And that pace looks likely to continue, thanks to some recent successes that could finally bring the first microbiome-based drugs to market.
Seres in August became the first company to detail results from a successful pivotal study, showing its microbiome drug could significantly reduce the return of Clostridioides difficile (C. diff) infections. The company plans to seek U.S. approval of its SER-109 capsule next year.
Two months earlier, a small Massachusetts biotech called Finch Therapeutics reported positive data in its own C. diff trial. Finch plans to run another study to confirm the results. Rebiotix, another microbiome drug developer, claimed success in a Phase 3 study earlier this year as well.
The U.S. government is also bolstering its interest in the field, with the Biomedical Advanced Research and Development Authority (BARDA) this week making its first award to a company pursuing a microbiome drug. PureTech Health said one of its subsidiaries, Vedanta Biosciences, will receive $7.4 million upfront from BARDA and as much as $69.5 million more to boost development of its experimental treatment VE303 for high-risk C. diff infection.
C. diff is a particularly tough bacterium to confront. A leading cause of hospital-acquired infections, it affects almost a half a million people a year in the U.S. and can cause diarrhea and potentially deadly colon inflammation. Fecal transplants have been used for patients suffering from C. diff, but the transplants themselves have sparked thorny regulatory questions.