Emerging Drug Developer: Resolvyx Pharmaceuticals

Resolvyx builds on a 100-million-year toxicity study

Resolvyx Pharmaceuticals is taking a cue from nature and turning it into new therapeutics.

In their case, the cue comes from the tonic qualities of omega-3 fatty acids, now a highly touted supplement to daily diets. Omega-3 fatty acids, which can be absorbed in a diet rich with sea food, are converted into resolvins in the body, which are known to have an anti-inflammatory affect. And that can have implications for a wide range of diseases.

Building on the scientific work of Charles Serhan, a scientist at Brigham and Women's Hospital, the biotech is advancing new therapies based on resolvins. And they’re starting out with what they believe is a key advantage in proving its safety. As CEO Paul Rubin notes, “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.”

To illustrate Resolvyx’s approach to drug development, Rubin quickly raises the example of Sirtris, a Fierce 15 company that has been making waves in biotechnology by developing a therapeutic version of sirtuins, an ingredient in red wine that has been linked to longevity.

It’s been a persuasive story. Resolvyx raised $17 million in its Series A round of venture capital when the company was formed in 2005, and just weeks ago added $25 million more in a Series B. The second round notably included Biogen Idec as an investor, along with Flagship Ventures, CHL Medical Partners, and Atlas Venture. Their money will be used to advance a clinical program to test a topical formulation for dry eye and push new research on asthma.

“It gets us through the third quarter of 2009,” says Rubin, the former CEO of Critical Therapeutics. “We have adequate capital for proof-of-concept in eye disease and systemic inflammation. We’ll have Phase II data in the fourth quarter of 2008, for systemic disease by late second quarter of 2009.”

But that’s just the beginning.

“It has multiple applications,” adds Rubin. Among other indications to explore are programs to prevent programmed cell death as well as promote wound healing. And Rubin raises the possibility of tackling rheumatoid arthritis as well as dermatological ailments. “It opens up many, many potential indications.”

Resolvyx detailed the results of In vivo studies which demonstrated that the resolvin drugs RX-10008 and RX-10001 (RvE1) were “highly effective in preventing clinical signs of dry eye--the most common corneal disease.” According to a company release, resolvins decreased “corneal inflammation, reducing corneal epithelial damage and preventing loss of goblet cells (the cells responsible for maintaining tear film integrity). In a second study, RX-10008 and RX-10001 (RvE1) accelerated corneal tissue repair with an effect level comparable to that seen with epidermal growth factor (EGF), the most potent previously-known mediator of corneal tissue repair. In a third study, RX-10008 and RX-10001 (RvE1) potently blocked several key proinflammatory mediators in dry eye syndrome. Together, these data form the basis for initiating clinical evaluation of resolvins for the treatment of dry eye.”

The company has had the assistance of an impressive group of advisors, including Nobel Prize laureate Bengt Samuelsson, the former president of the prestigious Karolinska Institute in Sweden, as well as Serhan.

The developer, which is based in Bedord, MA, has a payroll of about 30, but doesn’t plan to do a lot of hiring.

“I think there will be some growth,” says Rubin. “But there’s so much expertise outside that we can leverage, we don’t need to build a lot of clinical expertise.

“We have the technical ability to do a Phase III,” he adds. “We wouldn’t have to find people. It becomes a question of cost of capital, driven by data and the financial environment. We’re open to multiple potential ways to proceed.

“The devil is in the detail,” says Rubin. And in this case, the details are all in the data. Positive Phase II data can keep the venture capitalists coming back to the table, offer a possible route to a public offering and also raise the prospect of partnerships.

“This has already captured the attention of other pharma companies,” says Rubin.