What is particularly important in light of yesterdays Insmed comparative study . . .
is the four logs of kill against Pseudomonas aeruginosa that the Ciprofloxicin (Pulmoquin) achieved. In a head to head study of Arikace and tobramycin inhalation solution (TOBI) both these inhalational drugs only achieved 2 logs of Pa kill. The beneficial effects on FEV1 (force expiration volume) test was about the same (helped by 8%). But Pulmoquin had four logs of bacterial kill. That suggests a very good potential for clinically significant statistical results for a Phase III. Cipro can also be taken orally at the same time and really eliminate any lung infections.
Will Lewis (CEO of INSM) presented a paper at the JPM Health conference and clarified the comparative data of Arikace v. TOBI. The importance of the study was the for the first time, the study monitors made the TOBI patients administer their twice per day doses. Thus the data was a bit closer than INSM wanted as the TOBI group did better than the head to head study of Cayston v. TOBI. So the closeness of the data is clarified. But it is the second study that points the way to the path for approval. So the equally important part of the Arikace v. TOBI study is the added value of having a once per day (SID) inhalational antibiotic. This administration advantage, the safety of administering an oral dose of Cipro while doing inhalational therapy and the apparent superior log kill of Cipro will be the key to the future.