Hyperoxaluria agent shows substantial treatment effect
Allena Pharmaceuticals, Inc. recently announced interim data from Study 206, its phase II basket clinical trial of reloxaliase, an orally administered, recombinant oxalate-degrading enzyme. Study 206 includes adult and pediatric patients suffering from the progression of primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease. Consistent with Allena’s prior clinical experience, enteric hyperoxaluria patients treated with reloxaliase in Study 206 demonstrated a substantial treatment effect. This includes enteric hyperoxaluria patients with advanced chronic kidney disease, a patient population not previously treated with reloxaliase, who showed reductions in urine oxalate and plasma oxalate. Treatment with reloxaliase was well tolerated in all patient populations, with no reported treatment-related serious adverse events, according to Allena.
Clinical registry launched for ED treatment
Urologist Judson Brandeis, MD, is launching the world’s largest clinical registry focusing on GAINSWave for erectile optimization. The Shock Wave Erectile Enhancement Trial (SWEET) Clinical Registry will utilize 50 top GAINSWave providers, led by Dr. Brandeis. GAINSWave is a marketing organization that educates consumers and raises public awareness for low-intensity shock wave therapy for erectile dysfunction. The primary goal of the SWEET Registry is to evaluate the efficacy of shock wave therapy across a wide group of participants, treating physicians, and shock wave protocols. Other targets of interest include identifying optimal treatment plans, identifying factors that predict superior outcomes, and quantifying long-term efficacy. AFFIRM Science, producer of the Nitric Oxide Boosting supplement, AFFIRM, and Premature Ejaculation supplement, PreLONG, is funding the initial stages of this prospective observational research study on shock wave therapy for erectile dysfunction.
Positive phase III data announced for PARP inhibitor
AstraZeneca and MSD Inc. announced positive results from the phase III PROfound trial of the PARP inhibitor olaparib (Lynparza) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (eg, enzalutamide [XTANDI] and abiraterone [ZYTIGA]). Study results showed a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival with olaparib versus enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. The safety and tolerability profile of olaparib was generally consistent with previous trials. AstraZeneca and Merck said they plan to present full data from the trial at a forthcoming medical meeting.
Supplemental NDA submitted for prostate Ca treatment
The FDA has accepted for review the filing of a supplemental new drug application for enzalutamide (XTANDI) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer, according to Astellas Pharma Inc. and Pfizer Inc. The application has also been granted priority review. Enzalutamide is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer. The submission is based on results from the phase III ARCHES trial presented at the Genitourinary Cancers Symposium and published in The Journal of Clinical Oncology (July 22, 2019 [Epub ahead of print]). Additionally, the submission is supported by data from ENZAMET, an Astellas-supported, investigator-sponsored phase III research study led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and sponsored by the University of Sydney. Results from ENZAMET were presented at the American Society of Clinical Oncology annual meeting and simultaneously published in The New England Journal of Medicine (2019; 381:121-31). Both trials met their primary endpoint. The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2019.