Near term Catalysts; Second Phase 2a Clinical Tria
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Posted On: 03/29/2016 3:11:42 PM
Near term Catalysts; Second Phase 2a Clinical Trial Topline Results
In June 2015, we initiated a second Phase 2a clinical trial of SYN-004 to evaluate the GI antibiotic-degrading ability and the safety of SYN-004, in the presence of the proton pump inhibitor (PPI), esomeprazole. Topline data is expected from the second Phase 2a clinical trial during the first half of 2016.
Phase 2b Clinical Trial Design
In September 2015, we initiated a Phase 2b proof-of-concept clinical trial of SYN-004. This randomized, placebo-controlled clinical trial is expected to enroll approximately 370 patients at up to 75 global clinical sites. This clinical trial is intended to evaluate the ability of SYN-004 to prevent CDI, C. difficile associated diarrhea (CDAD) and AAD in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone. Once 120 patients are enrolled and there are 10 confirmed cases of CDI, an interim analysis to evaluate baseline rate of CDI in the placebo group is anticipated to be conducted during the first half of 2016. The interim analysis will be performed by an independent data monitoring committee. As of March 8, 2016, 98 patients are enrolled in the SYN-004 Phase 2b clinical trial.
Summary of Clinical and Preclinical Programs:
Therapeutic Area Product Candidate Status
Treatment of IBS-C
SYN-010
oral modified-release lovastatin lactone)
• Reported positive topline data from two Phase 2 clinical trials (4Q 2015 & 1Q 2016)
• Request end of Phase 2 meeting with FDA (summer 2016)
• Plan to initiate Phase 3 clinical trial(s) (2H 2016)
• Collaboration with Cedars-Sinai Medical Center
Prevention of CDI and AAD
(Degrade IV beta-lactam antibiotics)
SYN-004
(oral enzyme)
• Reported positive Phase 1a/1b data (1Q 2015)
• Initiated Phase 2b proof-of-concept clinical trial (3Q 2015)
• Reported supportive topline data from first Phase 2a clinical trial (4Q 2015)
• Expect to report topline data from second Phase 2a clinical trial (1H 2016)
• Plan to initiate Phase 3 clinical trial(s) (2H 2016)
Prevention of CDI and AAD
(Degrade oral beta-lactam antibiotics)
SYN-007
(oral enzyme)
• Preclinical work ongoing to determine ability of SYN-007 to protect the gut microbiome and degrade oral beta-lactam antibiotics
Prevention and Treatment of pertussis
SYN-005
(monoclonal antibody therapies)
• Reported positive preclinical research findings (2014)
• The University of Texas at Austin (UT Austin) received a grant to support a preclinical study to evaluate the prophylactic capability of SYN-005 (4Q 2015)
• Collaborations with Intrexon and UT Austin
http://www.sec.gov/Archives/edgar/data/894158...75_10k.htm
Guess you could say I have a few that may show their colors April - June time frame.
In June 2015, we initiated a second Phase 2a clinical trial of SYN-004 to evaluate the GI antibiotic-degrading ability and the safety of SYN-004, in the presence of the proton pump inhibitor (PPI), esomeprazole. Topline data is expected from the second Phase 2a clinical trial during the first half of 2016.
Phase 2b Clinical Trial Design
In September 2015, we initiated a Phase 2b proof-of-concept clinical trial of SYN-004. This randomized, placebo-controlled clinical trial is expected to enroll approximately 370 patients at up to 75 global clinical sites. This clinical trial is intended to evaluate the ability of SYN-004 to prevent CDI, C. difficile associated diarrhea (CDAD) and AAD in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone. Once 120 patients are enrolled and there are 10 confirmed cases of CDI, an interim analysis to evaluate baseline rate of CDI in the placebo group is anticipated to be conducted during the first half of 2016. The interim analysis will be performed by an independent data monitoring committee. As of March 8, 2016, 98 patients are enrolled in the SYN-004 Phase 2b clinical trial.
Summary of Clinical and Preclinical Programs:
Therapeutic Area Product Candidate Status
Treatment of IBS-C
SYN-010
oral modified-release lovastatin lactone)
• Reported positive topline data from two Phase 2 clinical trials (4Q 2015 & 1Q 2016)
• Request end of Phase 2 meeting with FDA (summer 2016)
• Plan to initiate Phase 3 clinical trial(s) (2H 2016)
• Collaboration with Cedars-Sinai Medical Center
Prevention of CDI and AAD
(Degrade IV beta-lactam antibiotics)
SYN-004
(oral enzyme)
• Reported positive Phase 1a/1b data (1Q 2015)
• Initiated Phase 2b proof-of-concept clinical trial (3Q 2015)
• Reported supportive topline data from first Phase 2a clinical trial (4Q 2015)
• Expect to report topline data from second Phase 2a clinical trial (1H 2016)
• Plan to initiate Phase 3 clinical trial(s) (2H 2016)
Prevention of CDI and AAD
(Degrade oral beta-lactam antibiotics)
SYN-007
(oral enzyme)
• Preclinical work ongoing to determine ability of SYN-007 to protect the gut microbiome and degrade oral beta-lactam antibiotics
Prevention and Treatment of pertussis
SYN-005
(monoclonal antibody therapies)
• Reported positive preclinical research findings (2014)
• The University of Texas at Austin (UT Austin) received a grant to support a preclinical study to evaluate the prophylactic capability of SYN-005 (4Q 2015)
• Collaborations with Intrexon and UT Austin
http://www.sec.gov/Archives/edgar/data/894158...75_10k.htm
Guess you could say I have a few that may show their colors April - June time frame.
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