Individuals in the study were assessed two years after NX-1207 treatment for symptomatic improvement, treatment outcomes, and durability of efficacy. This is the largest cohort of patients treated with NX-1207 followed for as long as two years thus far. The company expects to report the results of the follow-up study in the next two weeks once final analysis of the data is completed.
NX-1207 has successfully completed three US trials and several smaller long term follow-up studies to date. The company’s Phase II double-blind, placebo controlled, randomized study showed positive efficacy and safety results for NX-1207 after three months in patients with benign prostatic hyperplasia (BPH). Overall, patients treated with NX-1207 showed after three months a mean improvement of 9.35 points in AUA symptom score values, the standard scale used to evaluate BPH drugs and treatments.
This improvement compares favorably to the 3.5 to 5 points reported in published studies of currently approved drugs for BPH and reached statistical significance when compared to placebo. Subjects treated with NX-1207 also showed an overall significant reduction in mean prostate volume.
The company says results of the trial demonstrated the excellent safety and side effect profile of NX-1207. Subjects treated with NX-1207 had no serious side effects. In particular, patients given NX-1207 had no significant sexual side effects.