Since its inception six years ago, Tetraphase has developed a strong pipeline with a lead broad spectrum candidate in Phase 2 clinical trials, another drug candidate in Phase 1, and several additional candidates in preclinical development. Importantly, Tetraphase’s pipeline antibiotics offer significant differentiation from drugs that are currently on the market or in development by other companies.
Tetraphase Pipeline
TP-434
A novel antibiotic, TP-434 has been shown to be effective against a majority of gram-negative multidrug-resistant (MDR) pathogens in preclinical studies. In Phase 1 studies, TP-434 was well tolerated, demonstrating an acceptable safety profile and excellent exposure.
TP-434 is ideally suited as a broad spectrum intravenous (IV) antibiotic with potential for oral stepdown for empiric treatment of severe and life-threatening bacterial infections. It has the potential to be used as a once-daily monotherapy capable of treating the majority of MDR gram-negative pathogens. TP-434 also offers potent, broad spectrum coverage of other serious and MDR gram-positive, anaerobic, and atypical pathogens.
Tetraphase is continuing to demonstrate TP-434’s differentiated profile in a Phase 2 study to assess the treatment of community-acquired complicated intra-abdominal infections (cIAIs) and via further planned studies with an oral formulation.
Additionally, in February 2012, Tetraphase announced a contract award from the Biomedical Advanced Research and Development Authority (BARDA) worth up to $67 million for the development of TP-434. The contract includes pre-clinical efficacy and toxicology studies; clinical studies; manufacturing activities; and associated regulatory activities to position the broad-spectrum antibiotic TP-434 as a potential empiric countermeasure for the treatment of inhalational disease caused by Bacillus anthracis, Francisella tularensis and Yersinia pestis.
TP-2758
Novel antibiotic TP-2758 is in development as an IV/oral compound specifically targeted as empiric monotherapy in complicated urinary tract infections (cUTIs). TP-2758 is in Phase 1 clinical development.
cUTI represents a category of bacterial infections with a high incidence of gram-negative pathogens. A rise in infections involving difficult-to-treat, resistant gram-negative pathogens has severely limited available treatment options, especially with an oral stepdown option.
TP-834
TP-834 is in preclinical development for treatment of moderate-to-severe community-acquired bacterial pneumonia (CABP) with IV/oral administration. TP-834 will be developed as a monotherapy with once-daily dosing targeting key CABP pathogens, including penicillin- and fluoroquinolone-resistant organisms and atypicals. Tetraphase has demonstrated that TP-834 has excellent in vitro potency and in vivo efficacy. The company anticipates initiating Phase 1 trials with TP-834 in the near future.
TP-271
TP-271, a novel antibiotic currently in preclinical development, is being developed to combat respiratory disease caused by bacterial biothreats and antibiotic-resistant public health pathogens. As development continues, TP-271 is anticipated to protect against certain biothreats agents, including Francisella tularensis, which causes tularemia; Yersinia pestis, which causes bubonic plague; Bacillus anthracis, which causes anthrax disease; and bacterial pathogens associated with community-acquired bacterial pneumonia (CABP), a significant public health threat and commercial market opportunity.
Tetraphase will be developing TP-271 with the financial assistance of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), which awarded a $36 million contract in October 2011 to support TP-271's development, manufacturing, and clinical activities.
Other Assets
Tetraphase’s proprietary drug engine, which has produced more than 2,600 proprietary compounds with novel molecular structures, continues to offer great potential for creating additional products with significant commercial value.
