© 2003 American City Business Journals Inc.

The U.S. Food and Drug Administration has granted orphan drug designation to AEOL 10150, Incara Pharmaceuticals Corp.'s drug candidate for the treatment of Lou Gehrig's disease.

Orphan drug designation can be granted by the FDA for treatments that might provide significant benefit to patients with serious, life-threatening diseases that affect fewer than 200,000 people in the United States.

Orphan drug designation qualifies a product for possible funding to support clinical trials, study design assistance from the FDA during development and for financial incentives, including seven years of marketing exclusivity upon FDA approval. In addition to market exclusivity, orphan drug status provides possible tax incentives for a company's investment.

Lou Gehrig's disease, or amyotrophic lateral sclerosis, results from progressive degeneration of both upper and lower motor neurons and is usually fatal within five years.

Incara said it intends to file an Investigational New Drug application for AEOL 10150 in the second quarter of 2004. The IND filing timetable hinges on the satisfactory completion of animal safety studies, and completion of the remaining components of the company's previously announced financing,

Incara closed on a bridge loan facility of $3 million from The Xmark Funds in late July. The company also has signed a nonbinding letter of intent for an additional $5 million in funding from Xmark. The additional $5 million is subject to satisfactory completion of a toxicology study.

Allowance of the IND by the FDA would permit Incara to initiate clinical trials. The clinical program will test the ability of AEOL 10150 treatment to extend the survival of ALS patients.

Research Triangle Park-based Incara Pharmaceuticals Corp. is focused on developing a new class of disease modifying antioxidant small molecules.