TBED-driven investors keep an eye out for existing intellectual property that could, with the right management team, develop into a local company with a market-ready product. Rev1, a nonprofit venture development organization that manages several for-profit investment funds, partners with Nationwide Children’s Hospital to support the commercialization of promising research that advances the hospital’s mission. For about six years, the Rev1 team monitored Nationwide’s research on the challenge of the bacterial biofilm, a catalyst for inflammation and exacerbations in chronic respiratory disease. When the time was right, they played a critical role in founding the company, Clarametyx Biosciences, in Columbus, Ohio.
Biofilms are present in about 80% of human bacterial infections and are the central drivers of progressive inflammation, tissue damage, and declining function in chronic respiratory diseases like cystic fibrosis, bronchiectasis and COPD, according to the National Institutes of Health. Based on positive safety and efficacy data from Phase 1 and Phase 2a studies, Clarametyx is optimistic that targeting the biofilm will benefit people with a wide range of respiratory diseases. [These types of diseases are likely to grow: earlier this week, Bloomberg cited World Health Organization data revealing only 14% of 9,500 cities met air quality standards for average annual fine-particulate matter)
Rev1 was positioned to observe early research that would lead to Clarametyx because of its role as an innovation-focused entrepreneurial service provider for the Central Ohio region through the Ohio Third Frontier Entrepreneurial Service Program. Rev1 senior advisory partner, Wayne Embree, connected early on with Nationwide Children's researchers Lauren O. Bakaletz, Ph.D., and Steven D. Goodman, Ph.D., who would eventually become Clarametyx’s scientific co-founders. "I was thoroughly impressed with the work that they'd done," said Embree. "I thought it was something that could be the basis for a startup then."
Matt McFarland, PhD, RPh, then vice president of technology commercialization and industry relations, and Kyle Murrah, PhD, senior licensing associate in the Nationwide Children’s Office of Technology Commercialization, were also watching the progress of the research. “Bakaletz and Goodman had discovered a critical component of bacterial biofilms, which are present in most bacterial infections,” said Murrah. “By targeting this particular component of biofilms, you could have a powerful therapeutic that could potentially work against a whole range of diseases. If you can weaken or destroy the biofilm, you improve your ability to clear the bacterial infection and reduce the associated inflammation. We felt that the time was right to move this outside of Nationwide Children's Hospital into a startup so that they could pursue clinical testing."
In 2018, Embree suggested they spin-out a company with a handpicked management team of experienced entrepreneurs with whom he and Nationwide Children’s had worked previously. Embree also proposed that, with a selected management team, Rev1 Ventures would lead the initial investment round.
Clarametyx launched in 2020. Nationwide Children’s and Rev1 collaborated to recruit a highly capable management team. Michael Triplett and Peter Kleinhenz--well-known and respected by Rev1 and Nationwide Children’s—joined as CEO and CFO, respectively. They also recruited an experienced life science executive, Chief Business Officer David Richards. In January 2021, Richards transitioned into the role of CEO; Triplett and Kleinhenz remain on the Clarametyx Board of Directors.
Clarametyx team members (LtoR)
Ella Balasa, community engagement advisor;
David Richards, CEO; Veronica Hall, COO;
Charles McOsker, CSO
Clarametyx raised $3 million in their first seed round; the Ohio Innovation Fund and Emerald Shoals Targeted Opportunities Fund joined Rev1 as investors. Embree continued his involvement with the company as a board member. He is now a board observer. Clarametyx then completed a $33 million Series A raise in 2024, further propelling its progress.
Margaret Barkett, PhD, interim director and director of licensing at the Office of Technology Commercialization at Nationwide Children’s, noted Rev1's critical role in creating Clarametyx:
“Rev1 has a lot of connectivity with Nationwide Children's and supporting their companies, and they have been integral in working with us on startups, including helping recruit several leaders as CEOs. Starting a company is an incredibly challenging endeavor. Rev1’s efforts were a big part of Clarametyx finally coming to fruition in 2020. Clarametyx is one of more than 1,600 companies Rev1 has supported and one of 150 companies in which Rev1 has invested. Rev1 estimates that more than 100 of these 150 are still active portfolio companies. Rev1 continues to support companies' post-investment through advisory, mentorship and access to critical services.”
Richards, the Clarametyx CEO, recently summarized the accomplishments of the company since its founding in 2020, saying,
“In five years, we've gone from having early candidates all the way through the IND (Investigational New Drug) enabling process, which allows the initial drug testing in a Phase 1 study in healthy volunteer participants in a clinical study. And now we have completed our 1b/2a study in cystic fibrosis, which is a safety and tolerability study. I'm incredibly proud of our team for accomplishing that in that time frame with the capital that we raised.”
Their next study will be a larger Phase 2, proof-of-concept study in several hundred patients with bronchiectasis and cystic fibrosis, then a registrational Phase 3 study. “We have more work to do to reach patients,” said Richards, “but we are optimistic about these early results and have strengthened our resolve to continue to advance this promising science.”
Fundraising has been challenging because targeting biofilms has been traditionally difficult, and attempts by others have been unsuccessful. However, Richards notes that no effort to develop this type of technology has ever reached this far into clinical development with a clearly defined mechanism and strong IP. “It's a potentially new category of therapeutics that we can use to treat chronic respiratory diseases,” said Richards. “That could be very beneficial to patients if our data continues to demonstrate the promise we’ve seen in our early studies.”
Clarametyx received a major funding boost in 2021 when Carb-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global nonprofit partnership, awarded them up to $14.2 million to advance through the completion of a Phase 1 clinical study. “That was a major boost to the company and validation for the platform that they're developing,” said Embree.
Rev1 continues to be involved in Clarametyx. "They're a valued investor, advisors, and they're a permanent part of our company in that respect," said Richards. "We wouldn't be standing here today if Rev1 hadn't believed in the promise of this technology."