Regulators with the U.S. Food and Drug Administration have handed local biotech Samumed LLC a special classification for one of its drug programs, granting the company a number of perks.
The status was granted for a drug program Samumed calls SM04646, which is being developed to treat an often fatal illness called idiopathic pulmonary fibrosis (IPF). This is a disease in which tissue deep in the patient’s lungs becomes thick and stiff, or scarred, over time. The formation of scar tissue is called fibrosis.
Samumed’s drug just went through Phase 1 trials in humans, where it appeared to be safe and well-tolerated by patients. In earlier studies (testing the drug in animals and lab dishes), the drug appeared to cause regression in fibrosis.
SM04646’s new classification is called “Orphan Drug Designation,” and it gives Samumed several benefits that lighten the burden of development, including guidance, reduced fees, and extended market exclusivity once the drug is approved.
This program is one of nine drug programs Samumed is working on. The company made waves last year when it was valued at $12 billion during a recent round of funding.