Confidence of SYN-004 gaining FDA approval is rapidly increasing. Riley stated that SYN-004 Phase 2a clinical trial will begin within 2 weeks, March 2015. Trimesta may be "sexy" but SYN-004 is going to do a lot of heavy lifting for the pps IMO.
"The PK data confirmed that SYN-004 acts as Synthetic Biologics intended. SYN-004 goes directly to the gut where intravenous (IV) antibiotics are excreted, with the intention of protecting the microbiome from a cascading set of events that often lead to potentially deadly C. difficile infections,"
"No clinically significant safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies"
"No meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period." We now have the answer to the big question about SYN-004 being confined to the intestinal tract, that is Huge.
A successful Phase II and beyond for SYN-04 is as much of a "sure thing" as one can hope to find in the risky world of biotech investing IMO. There is also the benefit of these trials moving along at a speedy pace. Riley is doing a good job of managing the process. The relationship between antibiotics and C difficile infections is already very well established. Since SYN-004 is safe & blocking the antibiotics only in the intestinal tract as intended it seems to me that a boatload of derisking has occurred.
Phase 2b (Proof of Concept) trial goals: Demonstrate SYN-004 efficacy at preventing CDAD following IV ceftriaxone & limiting disruption of the gut microbiome by IV ceftriaxone. SYN needs a big enough trial to achieve statistical significance given the rate of c-diff following IV antibiotic therapy. The FDA will want to see a decrease in c. dif rates between those who get SYN-004 plus antibiotic and those who get a placebo plus antibiotic. Riley has been quite clear that this is the approval strategy that SYN has chosen.
Recall the successful Finnish Phase 1 & Phase 2 clinical trials already conducted in the EU. We already KNOW that SYN-004 works as advertised. What an advantage for Riley & Co when designing their strategy for gaining approval from the FDA. It's like being given the answers prior to your big final exam. SYN-004 is a Slam Dunk. GLTL!
I'll post more of the company info soon but wanted to share this post here. Thought there was a more recent topic on SYN here. I'll try and get here more often.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7762 | From: Virginia | Registered: May 2006
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