Resolvyx sets out to leverage positive Phase II data
Resolvyx Pharmaceuticals is rolling out a set of Phase II data today demonstrating that its lead drug for chronic dry eye passed its first crucial efficacy trial. And the company says its success in the clinic has cleared the path to a late-stage test in the first half of next year while building hopes that the developer can leverage the data by striking new partnership deals and possibly raising fresh venture capital.
Resolvyx's first-in-man trial for RX-10045-which combined a two-step approach to illustrate the safety of the therapy as well as its effectiveness--was designed to capture the attention of everyone in the biopharma field working on dry eye.
Rather than recruit a handful of patients for a classic Phase I study, standard operating procedure for an entry-level clinical trial, researchers signed on 232 participants. Researchers studied the safety and tolerability of three different dosages in the first step and then concentrated on the efficacy of the best dose for step two, says Jamie Nichols, the chief operating officer of Resolvyx. And they reported a statistically significant reduction in symptoms ranging from dryness and stinging to burning and grittiness sensations.
Bedford, MA-based Resolvyx hopes to make a name for itself developing a whole new class of anti-inflammatories known as resolvins. The company uses a derivative of Omega-3 fish oil to develop its therapies, which it intends to test against a range of ailments that also include inflammatory bowel disease and asthma.
In its trial of RX-10045, patients either received daily treatments of the Resolvyx therapy or a placebo over four weeks. The therapy hit its goal on relieving symptoms of chronic dry eye but fell short of achieving a statistically significant improvement in the signs of dry eye--what's technically referred to as CAE-induced staining of the central cornea--compared to a placebo.
"We didn't miss by much," Nichols says about the second efficacy goal of the trial. It's likely, he adds, that adding more patients to a late-stage trial would put Resolvyx over the top on that score as well.
Resolvyx has a big market in mind. Some 25 million to 30 million Americans suffer from the condition. So far, only Allergan's Restasis is approved to treat the condition.
"There is an urgent need for new treatment options in dry eye and the results of this Phase II study are as strong as any I have seen," said Stephen Pflugfelder, MD, an expert in dry eye at Baylor College of Medicine, in a statement. "Based both on these clinical results and on its unique mode of action, I am confident that RX-10045 can be an important new treatment modality for these patients."
The company plans to launch a Phase III trial of the therapy in the first half of next year, says Nichols. Resolvyx has another therapy, RX-10001, in a Phase I trial that it hopes will indicate potential for treating asthma and inflammatory bowel disease. Early stage data should be in hand for 001 by the end of the year, setting the stage for a mid-stage study next year.
Resolvyx has been building on the scientific work of Charles Serhan, a scientist at Brigham and Women's Hospital. As FierceBiotech reported back in early 2008, soon after Resolvyx raised $25 million from its Series B, developer was confident that it was working with a safe ingredient provided by mother nature.
As then CEO Paul Rubin noted, "people have been exposed to these things as long as there have been cold water fish around. We've essentially run a toxicity study that's a 100 million years old."
Rubin left the company earlier this summer, triggering a search for a new CEO. But Nichols, working with Executive Chairman Greg Weinhoff, intends to pick up where Rubin left off, pursuing new partners and possibly a new venture round.
"We plan to refinance the company in the next six months," adds Nichols, noting that the right partnership deal, if completed, could give Resolvyx all the money it needs for its next stage of development.