Novel treatment effective against OAB in phase 2 study

American Urological Association 2021 meeting report

Priscilla Lynch presents a round-up of the latest overactive bladder research presented at the 2021 American Urological Association meeting

The novel muscarinic M3 receptor antagonist DA8010 significantly reduced urine frequency and urgency episodes compared with placebo in adults with OAB, according to new data presented at the virtual 2021 AUA meeting. Dr Hee Seo Son, MD, PhD, of Yonsei University College of Medicine in South Korea, presented phase 2 trial data about the novel agent.

Dr Son and colleagues conducted the phase 2, randomised, double-blind, parallel-group, active reference- and placebo-controlled trial at 12 centres in South Korea. The study cohort included 306 patients, 69.93 per cent of whom were women. The patients had symptoms of OAB for three months prior to enrolment.

The researchers randomly assigned patients to receive one of four treatments: 2.5mg of DA8010; 5mg of DA8010; 5mg of solifenacin succinate or placebo. The treatments were administered once daily for 12 weeks. The researchers evaluated DA8010 for its clinical efficacy, safety and optimal dosage.

At 12 weeks, the mean values for 24-hour frequency were -1.01 in the placebo group, -1.22 in the DA8010 2.5-mg group, -1.56 in the solifenacin succinate group and -1.67 in the DA8010 5-mg group.

The difference in mean frequency was insignificant in the DA8010 groups compared with the solifenacin succinate group. However, compared with placebo, both DA8010 treatment doses exhibited significant differences in 24-hour frequency at four and eight weeks, and this difference remained significant at 12 weeks (P=.0413). Also, the 5mg dose of DA8010 was associated with significant reductions in the number of urgency episodes at four (P= .0278) and eight (P=.0092) weeks compared with placebo, according to the researchers.

Adverse drug reactions occurred in 3.95 per cent of patients in the placebo group, 6.67 per cent of patients in the DA8010 2.5-mg group, 18.42 per cent of patients in the DA8010 5-mg group and 17.33 per cent of patients in the solifenacin succinate group.

DA-8010 will now advance to phase 3 development.