–If approved, UGN-102 would be the first non-surgical first-line treatment for highly relapsing, multi-resectable bladder cancer.
PRINCETON, NJ–( BUSINESS WIRE )– UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on developing and commercializing innovative solutions for the treatment of urologic and specialty cancers, announced the Phase 3 ENVISION study of UGN. 102 (mitomycin), an intravenous solution for the treatment of LG-IR-NMIBC, is receiving full enrollment. The ENVISION study was designed to enroll 220 patients at 90 sites and, assuming positive results, UroGen expects to submit a New Drug Application (NDA) for UGN-102 in 2024.
“The completion of enrollment in the ENVISION trial is a major milestone that brings us one step closer to validating chemoablation for the treatment of LG-IR-NMIBC,” said Sandeep Prasad, MD, director of genitourinary surgical oncology at Morristown Medical. Center, Atlantic Health System, NJ, and principal investigator of the ENVISION trial. “These patients face the burden of disease recurrence and repeat surgery, which is especially common in the elderly, who have co-morbidities that increase the risk of surgery. If successful, ENVISION could fundamentally change the way we treat these patients.”
ENVISION is a phase 3, single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy in 220 patients with LG-IR-NMIBC from 90 sites. The ENVISION phase 3 trial design is similar to the 2b OPTIMA II trial in that the patient population will have similar clinical characteristics, receive the same treatment regimen, and undergo similar efficacy, safety assessment, and quality control. Patients enrolled in ENVISION will receive 6 weekly intravenous infusions of UGN-102. The primary endpoint was a complete response to PDE (primary disease assessment), usually occurring within three months of the first infusion, and the primary secondary endpoint was the durability of the response in patients who achieved a complete response.
“We are optimistic about the clinical potential of UGN-102 as ENVISION shares a similar approach to the successful OPTIMA II Phase 2b study,” said Mark Schoenberg, UroGen’s Chief Medical Officer. “Also, our chemoablative treatments for low-grade upper urinary tract cancer and UGN-102 use our proprietary RTGel™ technology, which mimics the mucosal properties of bladder and upper urinary tract cells. If approved, UGN-102 may have the added benefit of being infused into the bladder through a urethral catheter in an outpatient setting.
If approved, UGN-102 could offer a simpler, less invasive, non-surgical approach to transurethral resection of bladder tumors (TURBT) because UGN-102 can be performed without anesthesia or special equipment. UroGen’s original product and UGN-102 use mitomycin as the drug’s active ingredient, but in different ratios, and both allow for local delivery and prolonged mitomycin retention of up to six hours.
Of the approximately 800,000 people living with bladder cancer in the United States, 80,000 have LG-IR-NMIBC. Patients with LG-IR-NMIBC face the prospect of recurrence and additional surgery. Currently, the only primary treatment is a surgical procedure known as TURBT that requires anesthesia. Each time a TURBT is performed, it can cause more burden and serious risks to the patient, such as pain, bleeding, infection, and trauma (such as perforation).
UGN-102 (mitomycin) for intravenous solution is a Phase 3 investigational mitomycin for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, UGN-102 is a sustained-release, hydrogel-based formulation that allows bladder tissue to remain exposed to mitomycin for a longer period of time, allowing for non-surgical treatment of tumors. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive results from ENVISION’s Phase 3 study, UroGen expects to submit a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical first-line treatment for bladder cancer. with high recurrence rates and multiple surgeries.
About UroGen Pharma Ltd.
UroGen is a biopharmaceutical company dedicated to creating new solutions for the treatment of urothelial and specialty cancers as patients need better choices. UroGen has developed RTGel™ Reversible Thermal Hydrogel, a hydrogel-based platform technology capable of enhancing the therapeutic properties of existing drugs. UroGen’s sustained-release technology is designed to keep the drug in the urinary tract tissue longer, making topical treatment a more effective treatment option. UroGen’s first commercial product, UGN-102 (mitomycin), an intravenous solution for patients with non-muscle-invasive bladder cancer, is designed for non-surgical tumor removal. UroGen is headquartered in Princeton, NJ and has operations in Israel. For more information, visit www.urogen.com or follow us on Twitter @UroGenPharma.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the progress, design, timing, and potential benefits of ENVISION’s Phase 3 trial; Design and potential benefit of UGN-102 in the treatment of LG-IR-NMIBC, including comparison with other therapies; UroGen’s Plans and Expected Timing for NDA Filing for UGN-102; UroGen’s optimism about the clinical potential of UGN-102; the potential for UroGen’s proprietary RTGel technology platform to enhance the therapeutic profile of existing drugs; and UroGen’s sustained-release technology makes local delivery more effective than other treatment options. These statements involve a number of risks, uncertainties and assumptions, including: the timing and success of clinical trials and potential safety and other complications, including ENVISION’s Phase 3 trials; the ability to obtain regulatory approvals on a timely basis or at all; ability to maintain regulatory approvals; difficulties related to commercial operations, including difficulties caused by the COVID-19 pandemic; any approved product labels; competition in our industry; the scope, progress and expansion of UroGen’s product candidate development and commercialization activities; market size and growth, level and level of market acceptance versus alternative treatments. In light of these risks and uncertainties and other risks and uncertainties described in the Risk Factors section of UroGen’s Form 10-Q filed with the SEC on November 10, 2022, UroGen’s filings with the SEC from time to time (available at http: //available at www.sec.gov), the events or conditions described in such forward-looking statements may not occur, and UroGen’s actual results may differ materially or adversely from those anticipated or similarly expressed. . Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this press release.