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Clinical Trials

Date: 2015-04-27

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at ECCMID 2015 (European Congress of Clinical Microbiology and Infectious Diseases), on April 25, 2015, in Copenhagen, Denmark

Company: Synthetic Biologics (USA - MD)

Product: SYN-005

Action mechanism:

  • monoclonal antibody. SYN-005 is designed to neutralize the pertussis toxin, thereby reducing the mortality rate in infants and potentially shortening the chronic cough in adults. Synthetic Biologics is developing SYN-005 through its Exclusive Channel Collaboration with Intrexon Corporation and academic researchers at The University of Texas at Austin to target and neutralize the pertussis toxin in order to reduce morbidity and mortality in infected infants.

Disease:

pertussis

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news:

  • • On April 27, 2015, Synthetic Biologics, a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, announced that preclinical data from its novel SYN-005 program for the treatment of Pertussis were presented in two posters at ECCMID 2015 (European Congress of Clinical Microbiology and Infectious Diseases), on April 25, 2015, in Copenhagen, Denmark.
  • The "Antibody Cocktail Effectively Treats Pertussis in a Baboon Disease Model" poster summarized preclinical efficacy data that support advancing Synthetic Biologics\' novel monoclonal antibody combination (hu1B7 and hu11E6), SYN-005, toward the clinic. The poster presented key data from both murine and non-human primate models with the following conclusions: In the murine model, prophylactic administration of hu1B7 and hu11E6, both individually and in combination, completely blocked the rise in white blood cell count that is characteristic of the disease and reduced bacterial colonization in the lungs. In the non-human primate model, therapeutic administration of SYN-005 reversed the rise in white blood cell count and accelerated the clearance of pertussis bacteria.
  • The second poster, entitled "Spontaneous Identification of Bordetella bronchiseptica in a Baboon Colony: Potential Ramifications for Bordetella pertussis Modeling" presented data that further evaluated 16 non-human primates and provided new information important to the future use of this model. "The data suggest that SYN-005 has therapeutic potential to diminish morbidity, long-term complications and mortality from Pertussis in critically ill infants," said Jennifer Maynard, Ph.D., Associate Professor at The University of Texas at Austin's McKetta Department of Chemical Engineering. "In addition, the data support a prophylactic approach for use in newborns that has the potential to save thousands of lives annually, particularly in the developing world where the unmet need is greatest.""
  • In September 2014, the FDA granted Orphan Drug designation to the company's proprietary SYN-005 monoclonal antibody combination for the treatment of Pertussis.
 

Is general: Yes