Aradigm's Pulmaquin Antibiotic Granted FDA QIDP Status
By Cyndi Root
Aradigm Corporation announced in a press release that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) status to its antibiotic Pulmaquin. The inhaled antibiotic candidate is for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa. QIDP designation confers certain benefits to Aradigm including priority review, fast-track eligibility, and marketing exclusivity.
Igor Gonda, CEO of Aradigm said, "Persistent lung infections with Pseudomonas aeruginosa are a key factor related to the poor quality of life and untimely death in non-cystic fibrosis bronchiectasis patients. The QIDP designation will accelerate the advancement of Pulmaquin development as a potential treatment for these patients."
Pulmaquin
Pulmaquin is a formulation of ciprofloxacin, a widely prescribed antibiotic. Currently available orally and intravenously, ciprofloxacin has broad-spectrum capabilities, acting against various kinds of bacteria. Pulmaquin (also called Dual Release Ciprofloxacin for Inhalation, DRCFI, or ARD-3150) is a mixture of liposome encapsulated (Lipoquin) and unencapsulated ciprofloxacin. Aradigm licensed its inhaled liposomal ciprofloxacin product candidates to Grifols S.A. in 2013.
Pulmaquin Clinical Trials
In preclinical studies and Phase I/II studies, Pulmaquin showed clinical safety. Two Phase III studies are underway, ORBIT-3 and ORBIT-4. ORBIT-3 began dosing in April 2014 and ORBIT-4 will begin dosing patients in 2014. Both studies are worldwide, placebo-controlled trials for patients with non-cystic fibrosis bronchiectasis (non-CF BE). About 250 patients will participate in each trial for a 48-week time period. Patients will cycle six times through 28 days of treatment or placebo, and then take 28 days away from treatment. Investigators will evaluate pulmonary exacerbations, the number of pulmonary exacerbations, and the quality of life improvements.
The GAIN Act
Pulmaquin was given QIDP status under the GAIN Act of the FDA Safety and Innovation Act. The Act provides pharmaceutical companies incentives to develop antibacterial and antifungal drugs. The Act specifies the organisms that qualify as high value targets including the Escherichia coli species, Acinetobacter, Pseudomonas, and Klebsiella.
Bronchiectasis
Bronchiectasis is a rare disease associated with chronic lung infections. The severe and chronic condition occurs due to abnormally dilating bronchi and bronchioles. Over 100,000 people in the U.S. and over 200,000 people in Europe suffer from a debilitating and often fatal cycle of inflammation and lung infection.