US Orphan Drug Designation Given to Peptide for CF-Related Infections

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US Orphan Drug Designation Given to Peptide for CF-Related Infections

By Ori Twersky

WASHINGTON (Reuters Health) Nov 05 - The US Food and Drug Administration

(FDA) granted orphan drug status to the experimental P113D peptide for the

treatment of cystic fibrosis-related infections, biotechnology firm

Demegen Inc. said on Tuesday.

P113D is a peptide derived from histatins, which are found in human

saliva. According to Demegen, P113D has been shown in pre-clinical testing

to act against bacterial isolates resistant to traditional antibiotics.

However, the company noted that a number of preclinical toxicology

evaluations still must be completed before human trials can begin.

Orphan drug designation is granted to therapies for diseases and

conditions affecting fewer than 200,000 people. The designation entitles

the sponsor to 7 years of marketing exclusivity if the product is

approved, as well as tax credits for the clinical research expenses and

assistance with the clinical development program.

Demegen President Ekstrom told Reuters Health the company needs

about $1.5 million to cover an animal inhalation study and a phase I study

in about 20 patients. He said the company hopes to raise that capital by

using the orphan drug tax credit to attract an already profitable

development partner.

If funding is secured and the animal study proves successful, Ekstrom

said, the company could file to begin human testing in 2003. Demegen is

currently designing the pre-clinical trial, he noted.

The Pittsburgh-based Demegen is a development-stage biotech specializing

in peptides for the treatment of infectious diseases.