FDA Designates Vast’s BIOC11 a Qualified Infectious Disease Product

The U.S. Food and Drug Administration (FDA) has designated Vast Therapeutics’ BIOC11 a Qualified Infectious Disease Product (QIDP) for the treatment of people with cystic fibrosis (CF) who have chronic pulmonary infections due to Pseudomonas aeruginosa.

The QIDP designation makes BIOC11 eligible for priority-review and fast-track statuses that can speed the therapy’s development.

BIOC11 uses nitric oxide (NO), a molecule that can damage cells by oxidizing important cellular components, like DNA, to combat bacterial infections. This strategy is also employed by cells in the immune system, which generate NO as a way to destroy invading bacteria. BIOC11 utilizes a synthetic, powder-based form of NO.

The FDA’s decision was announced by Vast Therapeutics, a subsidiary of KNOW Bio, which is developing BIOC11. The QIDP designation was established by the Generating Antibiotic Incentives Now Act of 2011 (GAIN Act), and aims to incentivize the development of new antibiotics to treat serious or life-threatening infections caused by pathogens.

This status makes BIOC11 eligible for the FDA’s Priority Review and Fast Track designations, which can speed development of the therapy. Further, if it is ultimately approved by the FDA, the designation grants Vast an extra five years of market exclusivity.

“We are very pleased that the FDA has granted QIDP designation to BIOC11,” Mark Schoenfisch, PhD, Vast’s president and chief science officer, said in a press release.

“BIOC11 reflects an advanced platform for the delivery of nitric oxide,” Schoenfisch said. “Chronic, persistent lung infections continue to increase in frequency and are a major factor impacting the quality of life and untimely mortality of patients across a broad spectrum of diseases. The QIDP designation will accelerate the advancement of BIOC11 regulatory approval as a potential treatment for these patients.”

Vast is planning to submit an Investigational New Drug application for the therapy, and to initiate clinical trials still this year.

“The designation of BIOC11 to QIDP status is yet another achievement for Vast and the KNOW Bio group. This designation for a new materials system underscores our commitment to foundational drug product technology. The QIDP success should decrease the timeline to serve our patients,” said Neal Hunter, CEO and chairman of the board of Vast Therapeutics, and managing director of KNOW Bio.

BIOC11 is the second therapeutic product for which Vast Therapeutics has received QIDP designation. The first was BIOC51, also a nitric oxide-based therapy.