Agents for overactive bladder and congenital adrenal hyperplasia are among the other products discussed.
PCa agent phase III data show significantly improved survival
Results from the pivotal phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer showed a statistically significant improvement in metastasis-free survival (MFS) with the investigational agent darolutamide plus standard of care (ADT) compared to placebo plus ADT (HR=0.41, 95% CI: 0.34-0.50; p<.001). This translates to a 59% reduction in the risk of metastasis or death, according to a report from Orion Corp. and Bayer. The median MFS was 40.4 months in the darolutamide arm compared with 18.4 months for the placebo arm-an overall improvement in median MFS of 22 months. A positive trend in overall survival was also observed (HR=0.71, 95% CI: 0.50-0.99; p=.045), and all other secondary endpoints demonstrated a benefit in favor of darolutamide. Importantly, the incidence of treatment-emergent adverse events with ≥5% frequency or of grade 3-5 was comparable between darolutamide and placebo arms; only fatigue occurred in more than 10% of patients (darolutamide plus ADT resulted in 12.1% vs. 8.7% in patients with placebo plus ADT). Quality of life outcomes were similar between the treatment groups. The data were presented at the Genitourinary Cancers Symposium in San Francisco and published in the New England Journal of Medicine (2019; 380:1235-46).
Overactive bladder agent meets primary endpoint in phase IIb study
Velicept Therapeutics’ next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in patients with overactive bladder. In the study, twice-daily administration of solabegron demonstrated a statistically significant improvement compared to placebo at week 12, as measured by the mean change in number of micturitions per day, the study’s primary endpoint. Solabegron also demonstrated statistical significance across multiple secondary endpoints, including percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes. The 12-week placebo-controlled VEL-2002 study enrolled 435 women ages 18 to 80 years suffering from OAB. Solabegron was generally well tolerated. Treatment-emergent adverse events and serious adverse events were infrequent and comparable between the solabegron- and placebo-treated groups.
Ligation tech to be integrated into robotic surgical system
Titan Medical Inc. and Teleflex Inc. have announced a collaboration under which Teleflex’s market-leading polymer ligation technology will be integrated into Titan’s development-stage, single-port robotic surgery system. Teleflex’s Weck Hem-o-lok polymer ligation system is used for vessel sealing and has enhanced clip security features. Titan Medical is developing the SPORT Surgical System, a single-port robotic surgical system comprised of a surgeon-controlled patient cart that includes a 3-D high-definition vision system and multi-articulating instruments for performing minimally invasive surgical procedures, and a surgeon workstation that provides an advanced ergonomic interface to the patient cart and a 3-D endoscopic view inside the patient’s body. Titan Medical says it intends initially to pursue focused surgical indications for the SPORT Surgical System, which may include one or more of gynecologic, urologic, colorectal, or general abdominal procedures.
Next: Phase III trial to evaluate OAB Tx in men on BPH treatmentPhase III trial to evaluate OAB Tx in men on BPH treatment
Urovant Sciences has initiated COURAGE, an international phase III trial to evaluate the safety and efficacy of vibegron for symptoms of overactive bladder in men who are receiving pharmacologic treatment for BPH. Vibegron is an investigational beta-3 agonist that has previously been evaluated in phase IIb and phase III studies in patients with OAB. The COURAGE study is a randomized, double blind, placebo-controlled trial in men with BPH who are also taking BPH medications but continue experiencing OAB symptoms. The study will be conducted in two phases, with the first phase focusing on safety and the second phase assessing efficacy and safety. Approximately 1,000 patients who meet eligibility requirements will be randomized to receive either 75 mg of vibegron or placebo daily for 24 weeks. The co-primary efficacy endpoints will be measured at 12 weeks and include change from baseline in the average number of micturitions per 24 hours and change from baseline in the average number of urgency episodes per 24 hours.
Positive interim phase II data reported for CAH treatment
Neurocrine Biosciences, Inc. recently announced positive interim results from a phase II proof-of-concept study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-74788, a proprietary corticotropin-releasing factor type 1 receptor antagonist, in adult patients with classic congenital adrenal hyperplasia (CAH). Results from this ongoing phase II open-label study demonstrated a reduction of at least 50% from baseline in 17-hydroxyprogesterone and adrenocorticotropic hormone levels in more than 50% of CAH patients treated with NBI-74788 for 14 days. Meaningful reductions were also observed in other biomarkers, including androstenedione. NBI-74788 was shown to be well tolerated with no serious adverse events reported to date. The company says it plans to meet with the FDA to discuss the registration program for NBI-74788 in adult and pediatric patients with CAH.
Antibiotic for prostatitis granted QIDP designation
Iterum Therapeutics plc recently announced that the FDA has granted Qualified Infectious Disease Product (QIDP) designations to the oral and intravenous formulations of sulopenem in four new indications: acute bacterial prostatitis, community-acquired bacterial pneumonia, gonococcal urethritis, and pelvic inflammatory disease. These new designations augment Iterum’s existing QIDP designations for oral and IV sulopenem for the treatment of uncomplicated urinary tract infection (uUTI), complicated urinary tract infection (cUTI), and complicated intra-abdominal infection (cIAI), which the FDA granted in 2017. The company is currently conducting three pivotal phase III clinical trials in uUTI, cUTI, and cIAI, and expects to report top-line results in the second half of 2019. Fast Track designation for all seven of these indications in both the oral and intravenous formulations has also been granted, according to the company.