Sophiris Bio Inc (NASDAQ:SPHS)’s stock fell more than 80% with 7.4 million shares changing hands compared to its average volume of 52,773 shares. It could be seen as investor reaction to unpromising interim analysis results announced by the company for its PRX302 related Phase III PLUS-1 trial.
Sophiris’ PRX302 is intended for the treatment of lower urinary tract symptoms of BPH (Benign Prostatic Hyperplasia). The Independent Data Monitoring Committee revealed that an analysis suggests that a treatment with PRX302 could not achieve pre-defined efficacy threshold at 12 weeks, based on the change in IPSS (International Prostate Symptom Score) score from baseline. This interim administrative analysis was planned to direct subsequent clinical trials for the candidate.
Sophiris Bio Inc (NASDAQ:SPHS) is a biopharmaceutical company engaged in the research and development of therapeutics aimed at treating urological disorders. PRX302 is its lead product candidate which is under late stage clinical trials for treatment of prostate cancer and symptoms of BPH. Its strategic development partners include The Johns Hopkins University, UVIC Industry Partnerships Inc., and Kissei Pharmaceutical Co., Ltd.
PRX302 related PLUS-1 trial is a randomized, double-blind, multicenter study designed to assess the efficacy and safety of a single administration of the drug for BPH. The primary study endpoint is the change in IPSS total score from baseline at 52 weeks. Secondary study endpoint will assess change in Qmax from baseline at 52 weeks. Sophiris completed the enrollment and dosing for approximately 479 patients in PLUS-1 around September 2014.
The interim analysis of PLUS-1 trial was conveyed to the Company and other directly involved stakeholders in a manner that they remain blinded to the study. The unpromising results won’t impact the trial and the company will continue to follow all patients up to 52 weeks to further assess the primary efficacy endpoint. The company expects to report further updates in 2H15.
Sophiris Bio Inc (NASDAQ:SPHS)’s reported significant increase in its research and development expenses through 2014, primarily due to higher expenses associated with Phase III PLUS-1 trial for which enrollment commenced in October 2013. Over the first nine-month period, the company incurred $20.62 million in R&D expenses during 2014, up from $6.14 million in 2013. The company ended 3Q14 with cash and cash equivalents of $16.17 million.
Given the unpromising results for PLUS-1 trial, the company may find hard time going forward unless it reports substantial improvement in primary endpoint at 52 weeks.
Sophiris Bio Inc (NASDAQ:SPHS) was listed in the exchange in 2013 August and since then, suffered from a gradual descent, in a grinding manner, towards near extinction. The technical picture lies far away from even any faint sign of strength but the downmove just took an unprecedented momentum this week. The 6-month long range of $2-$3.50 resolved on the downside and any bottom fishing attempt now, even after this 80% drop, looks too risky. Staying away till it manages to form a bottom may be the prudent step.