Cempra Expands Clinical Management Team to Advance Leading Antibacterial Clinical Programs Solithromycin and TAKSTA™

- David Oldach, M.D. joining Cempra as vice president, clinical research, to help lead clinical development of solithromycin and TAKSTA

- Three additional clinical management appointments are highly experienced in anti-infective clinical development

- Oral solithromycin undergoing Phase 2a CABP Studies, intravenous solithromycin in Phase 1 and TAKSTA in preparation for Phase 3 trials in aBSSSI

Mar 03, 2011, 08:00 ET from Cempra Pharmaceuticals

CHAPEL HILL, N.C., March 3, 2011 /PRNewswire/ -- Cempra Pharmaceuticals today announced the appointment of David Oldach, M.D. as vice president, clinical research as well as announcing an expansion of its clinical development team to manage the company's leading clinical programs, solithromycin and TAKSTA through advanced clinical development.  The four appointments have significant anti-infective clinical development experience.

Solithromycin is Cempra's innovative oral and intravenous next-generation fluoroketolide exhibiting high potency against respiratory pathogens, including drug-resistant strains, and broad spectrum activity against other serious pathogens.  The oral form is undergoing a global Phase 2 clinical trial in patients with community-acquired bacterial pneumonia. Intravenous solithromycin is undergoing multi-dose and dose escalation Phase 1 trials in healthy volunteers. Results from both the Phase 2 oral and the Phase 1 intravenous studies are expected in the second quarter 2011.

TAKSTA is an innovative oral dosing regimen of sodium fusidate, employing a PK-PD-based proprietary dosing regimen, under development for gram-positive infections including drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).  TAKSTA has completed enrollment in a Phase 2 trial and is preparing for Phase 3 studies in the U.S. for acute bacterial skin structure infections (aBSSSI).

"Both of our lead clinical programs have made substantial progress over the last year," said Prabhavathi Fernandes, chief executive officer of Cempra.  "Solithromycin is now in development with both oral and intravenous formulations for CABP.  TAKSTA, now in preparation for Phase 3 trials in acute bacterial skin and skin structure infections, has potential in treating osteomyelitis and lung infections in cystic fibrosis patients.  This progress requires us to continue to allocate resources to build a very experienced clinical management team so we can continue the progress of these two differentiated antibiotic candidates and maximize their chances for success."

Dr. Oldach will be working closely with Jennifer Schranz, M.D., vice president, clinical affairs, in advancing both programs into pivotal clinical trials.  He joins Cempra from Gilead Sciences, where between 2006 and 2011 he helped lead the early clinical development of the company's hepatitis C (HCV) pipeline. He also supported supplemental New Drug Applications (sNDAs) in the U.S. and Marketing Authorization Applications (MAAs) in the European Union as well as Investigational New Drug Applications (INDs) for seven unique compounds.  Prior to Gilead Sciences, Dr. Oldach was an associate professor of medicine at the University of Maryland School of Medicine, where he also received his medical degree, and served as the Infectious Disease Section Chief in the Baltimore Veterans Administration Hospital.  He has published over 50 peer-reviewed articles and 12 invited editorials and book chapters.  He is an elected fellow of the Infectious Disease Society of America.

Jane Anderson, Ph.D. joins Cempra as director of clinical research and operations following nearly 20 years of experience at several biopharmaceutical companies.  She will be responsible for directing the multiple clinical operations of the company.  She was a key contributor to the ultimate NDA submissions and approvals for two anti-viral agents, while at Gilead.  

Angela Paulovits joins Cempra as a clinical study manager following her tenure as a clinical research associate at ICON Clinical Research.

Sara Wu, Ph.D., is joining Cempra as a senior chemist.  She has over 12 years of experience in pharmaceutical formulation development.  

Jennifer Shranz, M.D., vice president, clinical affairs for Cempra, added, "Our two leading clinical candidates are rapidly progressing to pivotal trials.  In addition, each has several promising applications beyond the lead indications that we are studying presently.  Bringing on these experienced pharmaceutical professionals will help us to both prioritize follow-on indications as well as expertly design all of our clinical development programs."  

About Cempra Pharmaceuticals

Founded in 2006, Cempra Pharmaceuticals is a privately-held, clinical-stage pharmaceutical company focused on developing antibacterials to address critical medical needs. Two lead products, both in late-stage clinical trials, address the urgent and increasing need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is well-funded and is committed to developing commercially and medically differentiated and novel products that reduce development risk and provide a high financial return. The company is also utilizing its proprietary compound library and chemistry technology to develop novel macrolides without antibacterial activity for non-antibiotic uses such as COPD, chronic inflammatory and GI disorders. Additional information about Cempra can be found at www.cempra.com.

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SOURCE Cempra Pharmaceuticals