A little extra PR for SYN today. Might help us a little next week.
We've seen this, but the more, the merrier.
Conference Update
April 22, 2017
As part of our ongoing coverage of the 2017 meeting of the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), we attended a late-breaking session on recent clinical trials. Affected companies include Synthetic Biologics (NYSE MKT: SYN), Seres Therapeutics (NasdaqGS: MCRB), and Achaogen (NasdaqGM: AKAO).
Analysts
David Sherman, Ph.D. (AC)
(212) 915-2570
dsherman@lifescicapital.com
Presentation #OS0250B: SYN-004 (ribaxamase) Significantly Reduced the Incidence of Clostridium difficile Infection in a Phase 2b Clinical Study.
Affected companies: Synthetic Biologics
Disruption to gut microbiome can lead to C. difficile infection
Antibiotics often the cause, as much as 50% excreted into intestine; disrupts bacteria in gut
Attempts to develop vaccines against the bacteria or the spores; it is toxin-mediated; some approaches look to neutralize the toxins; rebiotics also to strengthen and repair the microbiome; fecal transplants as well
What if we could prevent this entire cascade from occurring?
Making the gut hostile to spore
SYN-004 - Beta lactamase that can degrade beta lactam antibiotics; orally administered
Preclinicaly, SYN-004 can degrade ceftriaxone in dog model; didn’t affect PK of antibiotic
In another model of gut dysbiosis, SYN-004 prevented the establishment of infection
Early clinical studies – well-tolerated, not absorbed into the system
Phase 2a – two studies – all ceftriaxone in the intestine degraded; can be given with PPI
Phase 2b study for SYN-004
Patients admitted for lower respiratory tract infection; treated with at least 5 days of ceftriaxone; could also receive a macrolide; greater than 50 years old.
Primary endpoint: prevention of c dificille; secondary: prevent non c difficile diarrhea
Received SYN-004 for 3 extra days to mop up any lingering antibiotic
Monitored for diarrhea and C difficile infection
1/3 concurrent drug use for stomach acid
TEAEs and SAEs were comparable between the groups
Cure rate was 99% for lower respiratory tract infection
Primary endpoint: 71% REDUCTION IN c difficile infection
3.4% vs ~2% p =0.045
Trend in all cause diarrhea; reduction in self-reported antibiotic associated diarrhea; reduction in patients treated for diarrhea
New C difficile colonization at 72 hours and 4 weeks; significant reductions; these patients were negative at baseline
SYN-004 reduced onset of new onset CDI; confirmed by central lab testig; well-tolerated and did not affect cure rate; did not reduce protocol-defined diarrhea, but did reduce in certain subgroups.
Q: carbapenems?
A: no, but we have another product to degrade those; this produce targets beta lactams and most cephalosporins
