Today Sophiris Bio (SPHS) announced that is has obtained positive phase 3 results for its trial in patients with benign prostatic hyperplasia — BPH. Shares of Sophiris are up by 178% on this news. The phase 3 trial uses the company’s drug PRX302 to treat these patients with BPH. The company reported that it met on the primary endpoint with statistical significance.
The drug demonstrated a statistically significant in the International Prostate Symptom Score — IPSS — total score from a from baseline over a 12-month period. The primary endpoint of the study produced an IPSS score of 7.60 vs 6.58 in the control group which generates a p-value of p = 0.043. The drug is safe and tolerable and no patients are experiencing any side effects.
The company now states that they will possibly run another phase 3 trial with with the same types of endpoints. If this other phase 3 trial also reports similar efficacy results to the ones seen today then the company can move forward with possibly filing an NDA for this drug. This is a huge market opportunity because this drug could potentially produce up to $2 billion in revenue annually.
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