INSM drug is good but ARDM drug 'Pulmoquin' seems 2 times better, says data
Great post by rehdvm2004 on Aradigm board:
"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."
The 4.2 log improvement was for BRONCHIECTASIS, NOT CF:
We tested once daily inhaled Pulmaquin in the ORBIT-2 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) 168 day, multicenter, international Phase 2b clinical trial in 42 adult patients with non-cystic fibrosis bronchiectasis. Statistical significance was achieved in the primary endpoint - the mean change in Pseudomonas aeruginosa density in sputum (CFU) from baseline to day 28: there was a significant mean reduction of 4.2 log10 units in the Pulmaquin group, reflecting an almost sixteen-thousand fold decrease in bacterial load, versus a very small mean decrease of 0.1 log10 units in the placebo group (p=0.004).
There was only a 1.43 log improvement in their CF trial:
We conducted a multi-center 14-day treatment Phase 2a trial in CF patients to investigate safety, efficacy and pharmacokinetics of once daily inhaled Lipoquin. The Pseudomonas aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load, decreased by a mean 1.43 log over the 14-day treatment period (p