Dyax looks like it may have just transformed into a commercial drug company today. Shares in the Cambridge, MA-based company (NASDAQ: DYAX) shot up 15 percent today after it said its lead drug in development, DX-88, helped patients in a late-stage clinical trial with a rare, life-threatening disease called hereditary angioedema.
Investors drove Dyax shares up 67 cents to $5 at the close of markets. The company said its experimental drug, given as an injection, worked in a trial of 96 patients with hereditary angioedema. It’s a genetic condition that causes rapid pain and swelling, particularly of the face and lungs. The trial, called Edema4, found that 94 percent of patients had a successful response to the drug at four hours following an attack, compared with 58 percent who did that well on a placebo. About 44 percent of patients on the drug reported that they felt “a lot better or resolved” for a full 24 hours after treatment, compared with 21 percent of patients in the placebo group.
Dyax, founded in 1995, is best known for a phage display technology that its licenses to other drugmakers as a discovery tool. It has no marketed products of its own, and has run up a $335 million deficit in its history, according to its most recent quarterly report with the Securities and Exchange Commission. Based on the results of the DX-88 trial, which match up with another pivotal study, the company plans to submit an application to the FDA to market the product shortly after the fourth quarter begins on Oct. 1. An estimated 10,000 patients in the U.S. have hereditary angioedema, although without yet setting a price for the drug, Dyax declined to specify how big it considers the potential market to be.
“This is good news for Dyax and for patients too,” said Mark Monane, an analyst with Needham & Co. on a conference call this morning with the company.
Dyax chief business officer Gustav Christensen said the company plans to market the product without a partner in the U.S.. It could face competition from Firazyr, a product approved for sale in Europe. That drug was developed by German drugmaker Jerini AG, which London-based Shire is attempting to take over. Another drug for hereditary angioedema that’s close to reaching the U.S. market is Cinryze, which is produced by Lev Pharmaceuticals of New York. Exton, PA-based Viropharma (NASDAQ: VPHM) said last month it had agreed to acquire Lev and obtain the rights to that product.
Dyax sounds confident in how its contender stacks up. When pressed by Monane to characterize the clinical trial results, CEO Henry Blair said, “I’d classify them as excellent. We’re very pleased with the result.” It may not be long before doctors and patients weigh in with their own verdict on how much the drug is really worth.