With $33 million in fresh backing, Clarametyx Biosciences Inc. is starting the first tests of whether its infection-busting technology can be effective in two different diseases.
Positive results would lead to strategic thinking about next steps – raising more capital for later-stage clinical trials, pursuing acquisition by a large pharmaceutical company, or something else, CEO David Richards said.
Development of new antibiotics has stalled nationally as antibiotic resistance rises. The Columbus startup's novel approach draws enthusiasm at medical conferences.
"It’s a new category, not another antibiotic class," Richards said in an interview. "We think this is going to be the preferred approach, therapeutically and for vaccination, addressing biofilms. We believe we're in a strong position to lead the space."
The Nationwide Children's Hospital spinoff is developing an antibody therapy that uniquely targets the slimy "biofilm" that bacteria build around themselves in persistent and drug-resistant infections. Collapse the film, and the immune system and antibiotics can work.
The Cystic Fibrosis Foundation joined repeat investors in a $33 million funding round that closed early this month, led by Columbus-based Ohio Innovation Fund. Most of the funding will go towards this year's clinical trials.
Seeking U.S. Food & Drug Administration is an expensive, seven-to-10-year process. Clarametyx was founded in 2020.
"I’m highly encouraged that we've been able to drive this lead asset to the clinic in two applications," Richards said.
Last year no serious adverse reactions were reported in an early trial in healthy volunteers. The next group underway is patients hospitalized with pneumonia – although still in the early phase to test safety, Richards said the team is "hoping to get some signals about efficacy."
Cincinnati-based Medpace is the contract research organization administering those trials.
The other application is in patients with cystic fibrosis, a genetic lung condition that leads to persistent and repeat infections. It will start with safety testing and possibly get early data on effectiveness.
Rho, a contract research organization based in North Carolina's Research Triangle Park, is administering that work, because it has experience in cystic fibrosis research and ties with clinics that specialize in the disease.
The startup also has a $3 million federal grant toward developing a vaccine using the antibody to prevent recurrent infections. That could be in clinical trials in about two years, Richards said.
Inventors Lauren Bakaletz and Steven Goodman, Children's microbial researchers behind several of the Columbus hospital's patents, have developed the technology for more than a decade, and had an earlier spinoff with a different version.
"They’re thrilled to see the progress because they have been working on it for so long," Richards said. "It’s going to be their seminal contribution to the field."
Children's, which has built a robust commercialization program, performs "amazing science" and supports its licensees and spinoffs with regulatory, IP, and financial aspects, Richards said.
"I can't overstate how great of a partner they've been for us," he said.
