Sophiris Bio

Sophiris Bio was a clinical-stage biopharmaceutical company focused on developing treatments for urological diseases, primarily benign prostatic hyperplasia (BPH) and localized prostate cancer. The company was founded as Protox Therapeutics Inc. in 2002, with one source mentioning James L. Heppell as the founder in May 2003, and later changed its name to Sophiris Bio, Inc. in April 2012. The company's operations were based in La Jolla, California, and Vancouver, British Columbia.

The company's lead product candidate was topsalysin (PRX302), a genetically modified recombinant protein designed for targeted drug delivery. Topsalysin was engineered to be activated only by enzymatically active prostate-specific antigen (PSA), which is found in high concentrations within the prostate. Upon activation, the protein would form pores in cell membranes, leading to localized cell death and tissue disruption, thereby minimizing damage to surrounding healthy tissue. The treatment was administered via a direct intraprostatic injection. Sophiris's business model was centered on advancing topsalysin through clinical trials to gain regulatory approval and commercialize it as a minimally invasive alternative to existing pharmaceuticals and surgical procedures, which often carry risks of sexual side effects.

Throughout its existence, Sophiris advanced topsalysin through multiple clinical trials. It completed a Phase 3 study for the treatment of lower urinary tract symptoms of BPH and two Phase 2 trials for the focal treatment of localized prostate cancer. In late 2015, the company announced that its Phase 3 "PLUS-1" study for BPH had met its primary endpoint. However, the company faced significant setbacks, including a patient death during a Phase 2b prostate cancer trial in 2018, though a subsequent investigation deemed the event was unlikely related to the drug. Despite receiving positive feedback from the FDA on a Phase 3 trial design for prostate cancer in late 2019, Sophiris was unable to secure the necessary funding or strategic partnerships to proceed. The company's stock was delisted from the Nasdaq in March 2020 due to non-compliance with the minimum stockholders' equity requirement and began trading on the OTCQB market. After an extensive, year-long process to find a buyer or partner failed, the company announced in May 2020 that its board of directors had approved an immediate shutdown of all operations, as its liabilities exceeded its assets.

Keywords: Sophiris Bio, topsalysin, PRX302, urology, benign prostatic hyperplasia, BPH, prostate cancer treatment, clinical-stage, biopharmaceutical, Protox Therapeutics, PSA-activated, focal therapy, drug development, delisted, ceased operations