Traverse sinks teeth into human periodontal study

Traverse Biosciences CEO Joseph Scaduto and an eager team of Stony Brook University researchers are champing at the bit over TRB-N0224.

It seems everyone wants a piece of TRB-N0224.

Already being tested as a potential treatment for lung injuries and for periodontal disease in dogs and cats, the flagship formula patented by Stony Brook-based Traverse Biosciences will now be pitted against inflammatory diseases threating bone and tissue around human teeth.

The National Institutes of Health has awarded Traverse Biosciences, in partnership with Stony Brook University’s School of Dental Medicine, a $1.32 million Phase II Small Business Technology Transfer award to study the pre-clinical safety and effectiveness of TRB-N0224, specifically as it relates to periodontal disease treatment.

Lorne Golub: Full speed ahead.

Lorne Golub: Full speed ahead.

The award “provides an infusion of non-dilutive capital that will allow us to demonstrate the pre-clinical safety and efficacy of this lead drug candidate,” according to Traverse Biosciences founder and CEO Joseph Scaduto, while scientific co-founder Lorne Golub – co-creator of TRB-N0224 – said he was “very pleased that Traverse Biosciences has been able to attract the financial resources necessary to advance this highly collaborative research-and-development program.”

“With this critical support from [the NIH], we can accelerate the commercialization of this platform technology for the treatment of periodontal disease, as well as a variety of other chronic inflammatory conditions,” Golub said.

The NIH becomes the latest benefactor to put chips on TRB-N0224, one of several patented compounds – key ingredients in a potential suite of anti-inflammatory drug therapies – developed by Golub and SBU chemistry and pharmacological sciences professor Francis Johnson and exclusively licensed to Traverse Biosciences by the Research Foundation for the State University of New York.

That study of TRB-N0224’s efficacy as a lung-injury treatment, conducted by Traverse Biosciences in conjunction with SUNY Upstate Medical University, is funded by a Department of Defense award. Efforts to commercialize the drug as a companion-animal periodontal treatment are funded by a $250,000 cooperative R&D agreement with Kansas-based veterinary biotech Aratana Therapeutics – and could lead to an exclusive sublicensing deal with Aratana, including $8.25 million in up-front and milestone payments and a cut of global royalties.

And various private investors have jumped aboard along the way, highlighted by a recent $500,000 seed-financing round led by Rochester-based venture capital fund Excell Partners.

Now add the NIH’s National Institute of Dental and Craniofacial Research to the backers list. The human-periodontal research will be led by Golub, a member of SBU’s Department of Oral Biology and Pathology, and Ying Gu of the university’s Department of General Dentistry.

Golub and Gu, named as co-principle investigators in the NIH award, will work in “close collaboration with Traverse Biosciences,” according to a company statement. Johnson, the TRB-N0224 co-creator who’s also credited as a Traverse Biosciences scientific co-founder, said the team is raring to go.

“Our experienced research team is very pleased to partner with Traverse Biosciences to commercialize this unique technology,” noted Johnson, who is also president of Stony Brook-based R&D and manufacturing company Chem-Master Development.

In addition to Golub and Gu – who said in a statement the NIH grant will “advance our research from benchtop to chairside, from idea to commercialization” – researchers working on the study include Maria Ryan, chairwoman of SBU’s Department of Oral Biology and Pathology, and Hsi-Ming Lee, a research assistant professor in Ryan’s department.

According to Scaduto, the eager team will likely have to wait a short while. Noting the NIH award is granted over two years – matching “the intended term of the project” – the Traverse Biosciences CEO said it would be several months at least until human periodontal testing actually commenced at Stony Brook Medicine.

First, the company must come up with enough TRB-N0224 to facilitate the test – and for that, Traverse Biosciences has turned to Albany Molecular Research Inc., a multinational, Albany-based contract manufacturer.

The NIH grant will cover the costs of producing 5 kilograms of the drug – and even that tiny amount will take “at least three months, probably six” to produce, according to Scaduto, who noted complicated technology-transfer processes, manufacturing specifics and other potential production hurdles.

The SUNY Upstate Medical University lung-injury study is also “just getting started,” Scaduto said Tuesday, though tests at Aratana Therapeutics’ facilities have been completed, and Traverse Biosciences is now awaiting word on that lucrative licensing agreement.

With that potential blockbuster looming, there’s no immediate rush on the human-periodontal study – the research timeframe can actually be extended if necessary, Scaduto noted – but company and university researchers are still eager to sink their teeth.

And they’re confident that two years will be enough time to prove TRB-N0224’s bite against human periodontal disease, the CEO added.

“We do have the option of extending the project for one additional year,” Scaduto said. “But we’re hoping that we’ll be able to successfully complete the project within the two-year timeframe.”


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