Privately held NeurogesX Inc. pulled in $35 million in its third financing round, which should allow the company to finish pivotal trials of its lead pain drug.
Anthony DiTonno, CEO and president for San Carlos, Calif.-based NeurogesX, said the company will use the proceeds to complete the pivotal trials for NGX-4010, as well as to expand the company's technological capabilities and to acquire additional products. It also will help with the new drug application submission for NGX-4010.
"We expect to be in the position to file an NDA sometime in the middle of 2005," DiTonno told BioWorld Today.
New investor Global Life Science Ventures led the financing round. Other new investors include Diamond Capital Management as agent for both Dow Employees' Pension Plan and the Union Carbide Employees' Pension Plan. Existing investors include Alta Partners, ARCH Venture Partners, Montreux Equity Partners, Walden International Venture Partners, TIAA-CREF (Teachers Insurance and Annuity Association) and the University of North Carolina.
The $35 million will carry the company at least through mid-2005 and the NDA filing, DiTonno said.
"We obviously would use some of the proceeds to do some in-licensing to extend the technology," he added. "Certainly, a portion of the funding would be used to add new things to the pipeline, outside of our lead product."
NeurogesX's lead product, NGX-4010, is a topical treatment for neuropathic pain that appears to offer a better side effect profile and a more convenient dosing regimen than standard treatments. The drug, a high-concentration capsaicin dermal delivery system, is in two Phase II/III pivotal trials to treat post-herpetic neuralgia. It also entered last October a Phase II/III pivotal trial to treat painful HIV-associated neuropathy; the product has orphan drug status in that indication. The trial is enrolling 300 patients. NGX-4010 demonstrated significant clinical results - a mean decrease in pain intensity of 40 percent - in the first 12 patients with HIV-associated neuropathy. Two-thirds of the patients experienced pain decreases of 30 percent or more. The pain reduction remained stable for at least 12 weeks, and the drug showed good safety and tolerability. Likewise, Phase II data of a single administration of NGX-4010 in post-herpetic neuralgia patients showed a clinically significant reduction of pain for at least 12 weeks.
NeurogesX expects to begin clinical studies in painful diabetic neuropathy patients in the second half of this year.
Juerg Eckhardt, of Global Life Science Ventures, joined the NeurogesX board in connection with the financing.
NGX-4010 is the only product in the clinic for NeurogesX.
"We've got a technology extension program, which is a different application for high concentrations of capsaicin, that we're in preclinical with," DiTonno said. "We could possibly be in the clinic with that one at the end of 2004."
While the company has not named the extension candidate, it would possibly cover applications outside of neuropathic pain, such as acute traumatic pain, chronic inflammatory pain and conditions affecting the urinary tract and bladder, DiTonno said.
NeurogesX was founded in 2000 by Wendye Robbins, who then was an assistant professor of anesthesia and perioperative care at the University of California at San Francisco. The company has raised about $65 million since its first equity round in June 2000, including the Series C.
It raised $23 million in its Series B round conducted in January 2002. (See BioWorld Today, Jan. 24, 2002.)