Staff Writer

Founded a year ago to develop drugs for orthopedic diseases, BioAssets Development Corp. recently closed an initial seed round and is positioned to start advancing its first program, a TNF inhibitor against pain caused by disc injury or herniation.

The Natick, Mass.-based firm closed $800,000 in seed funding, with money coming from an undisclosed institutional investor and orthopedic spine surgeons, and it's conducting an ongoing convertible note offering through the end of this year "targeting an additional $1.5 million," said BioAssets President Jim Gorman, who founded the company with Robert Kamen, chairman and chief scientific officer, with the aim of taking existing biologics, such as TNF inhibitors, and expanding them into new indications.

They are products that have broad potential, but the orthopedic area "for a variety of reasons does not make it to the top of the priority list" of the companies that own them, Gorman said, adding that the name BioAssets refers to "the capabilities tied up in these products that we can help unlock."

Because the orthopedic indication is off-label, BioAssets can investigate the mechanism of action of an existing biologic in preclinical and clinical studies. At some point, either before or after reaching proof of concept, the company will seek to partner with a firm that has an existing marketed or late-stage product.

"We're in active discussions with a number of partners" that have drugs designed to inhibit tumor necrosis factor (TNF), he said.

It's no surprise that the company's first program focuses on the use of TNF inhibitors, since Gorman and Kamen are both alumni of Abbott Park, Ill.-based Abbott Laboratories, the firm that markets the blockbuster rheumatoid arthritis drug Humira (adalimumab). Gorman previously served as director of strategic initiatives at Abbott, and Kaman, whose company BASF Bioresearch Corp. developed Humira, joined Abbott after the health care giant acquired BASF.

An antibody product that inhibits tumor necrosis factor, Humira also gained approval in psoriatic arthritis and, most recently, in ankylosing spondylitis, and is one of the big three anti-TNF biologics on the market - the other two being Remicade, by Malvern, Pa.-based Centocor Inc., and Enbrel, by Thousand Oaks, Calif.-based Amgen Inc. Beyond those, a number of other products aimed at inhibiting production of the pro-inflammatory cytokine are in various stages of development across multiple indications.

Gorman said he and Kamen were interested in one indication in particular.

"We became aware of this whole spine angle," he told BioWorld Today. "TNF is actually implicated as a key orchestrator of the pain that comes from disc herniation."

BioAssets gained patents covering the use of TNF inhibitors for conditions related to TNF-mediated disc injury, including sciatica, which is characterized by "intense, unremitting" pain in the back and legs, Gorman said.

For a subset of patients, that pain persists for as long as 12 months, and studies to date have shown that it's the TNF released by the injured disc and systemic macrophages that results in the immediate pain and leads to peripheral nerve damage, he added. By blocking the production of TNF, "we could help [patients] manage pain and stop the damage to their nerve roots."

BioAssets plans to begin with preclinical studies using a marketed product. Development work will include investigating dosing levels and routes of administration to see what works best in sciatica, which might require a much different regimen than rheumatoid arthritis.

Gorman said he's "not particularly concerned" by disappointing data reported last year of an oral TNF-alpha inhibitor developed by South San Francisco-based Renovis Inc. That drug, REN-1654, missed its endpoint in a Phase II trial in 74 patients with sciatica. On that news, Renovis dropped work on the drug, which also had missed in an earlier post-herpetic neuralgia study. (See BioWorld Today, Aug. 29, 2005.)

REN-1654's mechanism of action "was poorly understood," Gorman said. "We've looked at the data, and we don't think it's at all indicative of TNF."

Early work with anti-TNF compounds in the orthopedic space has demonstrated "a signal of potential efficacy," he added, "and we're committed to optimizing" that potential.

BioAssets' seed round is expected to carry the company into 2007, through partnering and proof of concept.

The company is staffed by two full-time employees and eight part-time employees.