BPH program overview

About BPH

Benign prostatic hyperplasia (BPH or enlarged prostate) is a non-cancerous enlargement of the prostate gland that commonly affects men who are age 50 and older. Despite available pharmaceutical treatments and surgical options, no single solution provides quick, long-term relief of symptoms without unwanted side effects.

What is BPH?

Benign prostatic hyperplasia (BPH) is an enlarged prostate gland often resulting in a constricted or partially blocked urethra that can lead to pain, discomfort and other complications with urinating.
BPH, and its associated clinical manifestations of Lower Urinary Tract Symptoms (LUTS), is one of the most common medical conditions of aging men in the United States, with approximately 70% of men aged 60-69 years and 80% of men older than the age of 70 being affected by BPH. If untreated, it can lead to urinary problems such as:

  • Trouble starting and stopping urination
  • Frequent and irregular needs to urinate, particularly in the night while sleeping
  • A weak urine stream
  • Painful urination or urinary retention, leading to bladder infections or stones or kidney damage

Limitations of Current Treatments

Our market research suggests that as many as 36 million men in the United States are affected by BPH with approximately 5 million of these men suffering from bothersome symptoms. While 3 million men are prescribed pharmaceuticals for BPH in the US each year, these treatments lack sustainable efficacy and are associated with undesirable side effects including sexual dysfunction. With current pharmaceutical treatments, symptoms will usually return if medication is discontinued. More aggressive treatment options include invasive surgical procedures that may be successful at treating BPH. However, any type of prostate surgery can cause side effects, such as semen flowing backward into the bladder (retrograde ejaculation), loss of bladder control (incontinence) and impotence (erectile dysfunction). There is a demand for better balance between efficacy, safety and quality of life.

A Singular Solution

The lead drug candidate at Sophiris, PRX302 (topsalysin), is designed to be a single treatment for the long-term relief of BPH symptoms, without causing sexual dysfunction or sacrificing quality of life. Late stage development of PRX302 is supported by a successful randomized Phase IIb study (TRIUMPH) with standard and well defined regulatory endpoints. PRX302 has shown meaningful improvements in the International Prostate Symptom Score (IPSS) and urinary flow rate (Qmax) at 3, 6 and 12 months in this randomized, double-blind, placebo controlled Phase IIb trial (TRIUMPH). Prior to Phase III, 126 patients with BPH had been treated with PRX302, demonstrating an attractive safety profile including no drug-related erectile dysfunction adverse events. Enrollment into a Phase III clinical trial (PLUS 1) has been completed.

IPSS has been a primary endpoint and Qmax has been a secondary (or co-primary) endpoint for the FDA approval of currently available drugs for the treatment of BPH.

Learn more about clinical development of PRX302 in BPH here.