Cempra Pharmaceuticals And Biovista Enter Agreement For Macrolide Clinical Trial Design Support Studies
Collaboration will help determine safety profiles to further advance clinical development efforts in important drug class
Chapel Hill, NC and Charlottesville, VA - September 30, 2008 - Cempra Pharmaceuticals, Inc., and Biovista, Inc., announced today that they have entered into a research agreement to systematically identify and profile adverse event associations for members of the macrolide drug class. The data generated will be used to better understand the unique benefit/risk characteristics of this important group of antimicrobial drugs, thereby helping to adapt and optimize future clinical trial designs.
“This collaboration with Biovista is a significant step forward in understanding macrolide safety profiles in a way that will help us further our clinical development plans, and ultimately further our goal to bring much-needed antimicrobial and therapeutic drugs to market,” said Prabha Fernandes, president and CEO of Cempra.
Cempra’s macrolide in development, CEM-101, recently completed an exceptionally clean Phase 1 study [with new data to be presented at the upcoming ICAAC conference in October]. “Our learnings thus far suggest we may well have that unique combination of safety and potency that you hope to find, yet we want to remain prudent in our efforts to bring a best-in-class macrolide drug to market,” said Fernandes. “Biovista’s unique adverse event profiling and repositioning technology will bring the highest quality of supporting data to Cempra’s clinical development efforts at an early stage, which is consistent with our approach, and is of course the central idea behind the FDA’s Critical Path Initiative.”
Cempra is a leader in the development of next-generation macrolides, a group of antimicrobial drugs that are active against aerobic and anaerobic gram-positive cocci. Macrolides are typically prescribed for the treatment of respiratory tract and soft tissue infections. With resistance to available macrolides and other antibiotics becoming an increasingly significant global problem, new alternatives are needed. Cempra’s lead candidate, CEM-101, is considered the most potent macrolide antibiotic currently known, and has shown activity in both in vitro and animal infection models against organisms with acquired resistance to available macrolides.[For more on this class of macrolides, visit http://www.cempra.com/technologies/promise/.]
“We are looking forward to working with the Cempra team on this interesting class of antibiotics,” commented Aris Persidis, president of Biovista. “Biovista has the resources and expertise to support the company's development plans, based on an in-depth understanding of benefit/risk correlations and how they can be applied to clinical trial design.”
Financial details of the collaboration were not disclosed. In addition to its antibacterial programs, Cempra is addressing non-antibiotic, therapeutic uses for macrolides and is screening its macrolide library for motilin-receptor activity, anti-inflammatory, activity and GnRH receptor antagonism. Cempra has exclusive rights to all uses and indications for more than 500 macrolides.
About Cempra Pharmaceuticals, Inc.
Founded in 2006, Cempra Pharmaceuticals, Inc., is a privately-held biotechnology company that discovers and develops well-differentiated medicines to cure bacterial infections and improve the quality of life for those with chronic illnesses. The company strives to meet urgent and rapidly expanding needs to treat patients with drug-resistant bacterial infections. Cempra balances near-term product development opportunities, including the macrolide CEM-101, while investing in future products from new technologies to derive the next generation of antibiotics. Cempra is utilizing its proprietary chemistry technology to develop macrolides without antibacterial activity for these non-antibiotic uses. Additional information about Cempra can be found at www.cempra.com.
About Biovista, Inc.
Biovista systematically de-risks and repositions drugs for new uses. It uses state-of-the-art drug, disease or adverse event screening, using large scale mode of action profiles. Starting with a drug of interest, Biovista's technology is used to identify potential adverse events and new indications. The drug could be in development, on the market, or a generic. Starting with a disease of interest, Biovista's technology is also used to find medically-relevant drugs that have never been used before for that disease and have IP potential. Additional information can be found at www.biovista.com.
Feinstein Kean Healthcare