Non-inferior simply means that eravacycline performs as well as current standard of therapy. In this case it was compared to levofloxacin. What we'd also expect is that eravacycline would be available to use against levofloxacin resistant bacteria, providing an alternate therapy where one doesn't exist. Further, the data seemed to suggest that the responder outcomes in the ITT arm seemed to respond about 20% better to eravacycline vs levofloxacin. You couldn't ask for better phase 3 results IMO, especially with the recent focus from the FDA around fast tracking antibiotic therapy's.
Forget non-inferiority compared to levofloxacin, in many cases eravacycline appears to be superior. Today's results de-risk TTPH. This is pretty much a buy and hold for acquisition. Perhaps after the pivotal portion of IGNITE2 completes or just ahead of NDA Filing. Comments?
The design of the trial was flawed. Unsurprising that it failed. However it doesn't change how the drug performs. A trial designed to assessment cardic parameters would have succeded. I can't explain why they choose time to rehospitilation as a primary endpoint. So while a Phase 2 trial failure is never good the drug itself is just fine. This will likely be discussed in the call. There is to much interest in improving CHF outcomes to give up. That will be the theme here.
The general sense is that Tetraphase will be bought before Phase 3 results come out. Brean's report confirmed prevailing street sentiment. Any thoughts on what a deal might look like? Prrojected sales x2 seems reasonable given what we saw with Merck and Actavis, but when you add in CRE, it seems the value may be higher. Assuming eravacycline has the potential to be a billion dollar drug (particularly given CRE efficacy), that would put us around a $74 buyout. Thoughts on who might be interested? It wasn't mentioned in Brean's report Friday, but perhaps Glaxo or Pfizer would be interested to compete with Merck's acquisition of Cubist.