- Thinly traded nano cap Citius Pharmaceuticals (CTXR +7.6%) is up on more than triple normal volume, albeit on turnover of only 255K shares, in response to a change in the primary efficacy endpoint in a Phase 3 clinical trial evaluating antibiotic lock solution Mino-Lok in patients with catheter-related or central line-associated bloodstream infections.
- The current endpoint is the proportion of patients who were successfully treated at week 8, meaning that Mino-Lok needs to demonstrate the disinfection of colonized catheters and the sustained functioning of infection-free catheters for eight weeks post-treatment, compared to standard-of-care (SOC) systemic antibiotic therapy. Target enrollment is 700.
- The new endpoint will be the time to catheter failure compared to SOC antibiotics, a change that the company says should reduce the number of required subjects to fewer than 150 and saving it ~$10M. The agency is currently reviewing the proposed smaller sample size.