Noveome Biotherapeutics Inc., of Pittsburgh, shared positive top-line safety results from three phase I trials of its multifaceted lead candidate, ST266, ahead of plans to move the cell-derived therapy into a phase II study in periodontitis this quarter.

In the first study, patients with partial thickness burns were administered topical ST266 according to one of three dosing regimens over a 21-day period. In another trial, patients with a history of dry eye syndrome were given ST266 eye drops four times per day for six weeks and observed for 30 days more following treatment. But it’s the third study, in gingivitis, that’s serving as a springboard for the company’s most immediate plans in periodontitis. In that trial, participants received intraoral ST266 once daily for two weeks, a treatment that led to improvements in the condition of both their gums and teeth, giving the company confidence to move ahead with the phase II.

Periodontitis, which is usually preceded by gingivitis, is a condition that impacts more than 47 percent of adults age 30 and older, according to the U.S. Centers for Diseases Control and Prevention. Its symptoms include serious inflammation of the gums that damages soft tissue in the mouth and destroys bone that supports teeth.

With ST266 appearing to modulate inflammation as well as to restore and promote bone growth, Noveome sees the candidate as a good bet, with positive performance on endpoints very similar to those that would be required by a periodontitis trial. “We were able to show an effect on both clinical attachment and pocket depth and also on the cytokines that are produced between the gum and the tooth,” Noveome’s CEO and president, Clarke Atwell, told BioWorld Today. “So you have a nice clinical endpoint and an effect on the biomarker,” he said.

The company, formerly known as Stemnion Inc., is also exploring other applications for the solution of molecules secreted from its proprietary cells, harvested from cesarean sections following full-term births. Areas of interest include both ophthalmology and wound healing. In a hamster model of impaired wound healing, for example, ST266 appeared to increase the rate of healing to a normal rate, said Atwell. In a potential back-of-the-eye indication, the orphan condition optic neuritis, the candidate has appeared to aid nerve regeneration and repair. Though the company has yet to select a lead indication in ophthalmology, it is also considering allergic conjunctivitis and dry eye.

Noveome, a 47-person company, was founded in 2000 by Lancet Capital directors William Golden and George Sing along with current and former faculty members of the University of Pittsburgh’s McGowan Institute for Regenerative Medicine. Together, they’ve worked to advance ST266, an amnion-derived cellular cytokine suspension, for years, first as a pluripotent stem cell therapy, and now in its current incarnation as a secretome therapy, leveraging the dynamic communication between cells mediated by secreted molecules and paracrine factors.

While the company originally sought to use its cells as a direct therapy, it eventually found that they “don’t like to be other cells, they like to be themselves,” said Atwell. “Trying to force them to be come hepatocytes or islet cells didn’t really work. So, the company started to look at the secretome that the cells produced.” The name change for the business, which arrived Wednesday, is part of that evolution.

Since its inception, the private company has raised $19 million of private equity financing and more than $100 million in nondilutive funding. Today, it has sufficient sources of committed capital to fund operations and multiple clinical trials into 2017, it said. As it moves ahead, Atwell said it will be important for the company to remain transparent, focused and disciplined in controlling the quality and design of its trials, all with an eye toward phase III studies.

Moving forward, the company has no small plans. It’s building a commercialization strategy that would allow it to take ST266 to market on its own and is even preparing for the possibility of an IPO after an interim financing.