Protez Initiates Phase II Study for Its Lead Product PZ-601 in Infectious Diseases
Protez Pharmaceuticals, a privately held biopharmaceutical company focused on the development of innovative antibiotics to combat drug resistant and life threatening infections, today announced the commencement of a Phase II clinical study of the company’s lead compound, PZ-601, in patients with complicated skin and skin structure infections. PZ-601 is a new, injectable antibiotic with a uniquely broad spectrum of activity against drug-resistant Gram positive pathogens including MRSA and Gram negative bacteria.
The Phase II clinical trial is projected to enroll approximately 100 adult patients at 20 sites in the U.S. The study will evaluate the safety and efficacy of PZ-601 in patients with complicated skin and skin structure infections including cellulitis, abscesses, infected wounds and ulcers.
“The rapid advancement of this program demonstrates the Protez team’s clinical development capability,” said Christopher Cashman, Protez President and CEO. “We are pleased that pre-clinical and Phase I human studies have supported this important next step in the development of PZ-601,” said Luigi Xerri, Ph.D., Chief Scientific Officer. “Feedback from clinical experts indicates that PZ-601 has the potential to combat infections that represent a significant health risk to patients across the globe, such as infections due to MRSA and multidrug- resistant Gram negative organisms,” said Clarence Young, M.D., Chief Medical Officer.
Antibiotic resistance has been called one of the world’s most pressing public health problems. The number of bacteria resistant to antibiotics has increased significantly in the last decade driven by methicillin-resistant Staphylococcus aureus (MRSA) and more recently, the emergence of beta-lactamase producing enterobacteriaceae. Following their discovery in the 1930s, antibiotics transformed medical care and dramatically reduced illness and death from bacterial infections. However, the past few decades has witnessed a dramatic increase in the emergence of bacteria resistant to these drugs. Multidrug-resistant microbes are considered by the Institute of Medicine of the National Academy of Sciences to be a substantial threat to US public health and national security.
About PZ-601
PZ-601 is a new carbapenem antibiotic with an extended spectrum of activity against multidrug-resistant Gram positive and Gram negative pathogens. PZ-601 has the potential to replace the use of multiple antibiotics for the treatment of infections in hospitalized patients where drug-resistant Gram negative or positive bacteria may be encountered. PZ-601 was licensed from Dainippon Sumitomo Pharma Co., Ltd.
About Protez Pharmaceuticals
Headquartered in Malvern, Pennsylvania, Protez Pharmaceuticals is engaged in the discovery and development of new antibiotics for difficult-to-treat infections. Its focus is on highly differentiated intravenous and oral small molecule antibiotics to address increasing bacterial resistant and chronic or recurrent infections. Protez intends to acquire, develop and commercialize additional antibiotic product opportunities to which it can add significant value by leveraging its core technologies and drug development expertise. For more information visit www.protez.com.