Urovant Sciences Announces Publication of Results from Phase 1 Clinical Trials Evaluating URO-902 Gene Therapy in Patients with Overactive Bladder
“This is the first publication of clinical data for a potential novel gene therapy delivered directly to the bladder,” said Dr.
About the Phase 1 Trials
Two double‐blind, placebo‐controlled, multicenter Phase 1 trials were performed in female patients with OAB and urodynamically demonstrated detrusor overactivity (DO). The aim of the trials was to demonstrate the safety and potential efficacy of URO‐902, which comprises a gene therapy plasmid vector expressing the human big potassium channel α subunit. Among the safety outcomes, there were no clinically relevant or dose‐limiting adverse events (AEs) preventing dose escalation during either trial, and no participants withdrew due to AEs.
For efficacy, a significant reduction versus placebo in urgency episodes and number of voids were observed as early as one week after injection. These improvements over placebo were statistically significant and observed over 24 weeks.
The full publication can be accessed online at https://onlinelibrary.wiley.com/doi/10.1002/nau.24272.
URO‐902, a gene therapy using a naked DNA plasmid vector, has the potential to be the first gene therapy for patients with OAB delivered directly into the bladder. This novel treatment has the potential to address an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions related to existing third‐line OAB treatments.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding Urovant’s plans to advance the clinical development of URO-902 in patients with OAB, as well as the clinical development of vibegron in patients with OAB+BPH and IBS-pain. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s filings with the