NEW YORK, April 12, 2016 /PRNewswire/ -- TGV-Inhalonix, Inc., a New York-based pharmaceutical company, today announced that its new drug candidate for treating antibiotic-resistant bacterial lung infections in patients with cystic fibrosis has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).
The FDA granted the special status for TGV-Inhalonix's antimicrobial agent Mul-1867.
"This is a breakthrough for our novel drug candidate, which has shown good results in early studies," said Dr. Victor Tetz, chief scientific advisor at TGV-Inhalonix.
"Previous studies have shown that Mul-1687 holds promise as a treatment for life-threatening pulmonary infections from Pseudomonas aeruginosa, Burkholderia cepacia, and other bacteria," said Dr. George Tetz, drug development advisor, at TGV-Inhalonix. "Our research revealed that Mul-1867 is more effective against antibiotic-resistant pathogens as compared with other drugs commonly used for the treatment of infections in cystic fibrosis patients."
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time.
The FDA granted the Orphan Drug Designation for Mul-1687 after reviewing multiple experimental research findings by TGV-Inhalonix. TGV-Inhalonix said its research indicates Mul-1867 holds promise for addressing unmet need for improved treatment of antibiotic-resistant pulmonary infections.
According to the Cystic Fibrosis Foundation, the median predicted survival age in persons with cystic fibrosis in the United States is 39.3 years. Chronic pulmonary infections lead to progressive decline in lung function and eventually respiratory failure in patients with cystic fibrosis.
TGV-Inhalonix also believes Mul-1867's unique mechanism offers a broad potential for the treatment of various bacterial and fungal infections, including respiratory tract infections in COPD patients, ventilator-associated pneumonia (VAP), and fungal pneumonia.
"Taken together, our data suggest that Mul-1867 is a promising novel antimicrobial agent that has potent broad-spectrum antibacterial activity against clinically important microorganisms," said Dr. Sushant Kumar, a member of TGV's advisory board. "TGV-Inhalonix has completed comprehensive preclinical and pilot clinical studies of Mul-1867 in Europe, showing good efficacy and safety profile in cystic fibrosis patients. Regarding development in the US, the company plans to conduct Investigational New Drug studies (IND) studies with an IND filing expected in 2018."
Mul-1867 data have been published in several scientific journals and were presented at major microbiology and infectious disease conferences including ASM-2015 and ICAAC-2015.
TGV-Inhalonix is a New York-based Research & Development pharmaceutical company that provides a broad range of innovative products that are developed, manufactured and marketed worldwide by TGV-Laboratories Group of Companies. The research of the TGV-Laboratories Group of Companies is focused on identifying new causes for diseases, as well as blueprinting and creating small molecules and recombinant proteins.
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