Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB)
March 28, 2019-
Study VEL-2002 further validates solabegron’s potential for
best-in-class efficacy across multiple primary and secondary endpoints
WAYNE, Pa.–(BUSINESS WIRE)–Velicept Therapeutics, a privately-held specialty pharmaceutical company
dedicated to the development of best-in-class compounds for the
treatment of urological and gastrointestinal disorders, announced that
its next generation beta-3 adrenoceptor agonist solabegron met the
primary endpoint in VEL-2002, a Phase 2b study in patients with
overactive bladder (OAB). 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 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. Velicept plans to submit the data from the VEL-2002 study for
presentation at upcoming scientific meetings.
“We are encouraged by these positive top-line results for VEL-2002 as
they are consistent with what we’ve seen in a prior study with
solabegron undertaken by GSK and further validate the potential for
best-in-class efficacy and improved safety for patients with OAB,” said
James Walker, President and Chief Executive Officer, Velicept
Therapeutics. “We look forward to the results of our second study, which
will help us finalize our plans for moving forward with a pivotal Phase
3 program early next year.”
Velicept has also developed a novel, once-daily formulation of
solabegron which is being evaluated in an ongoing Phase 2b study
(VEL-2001). VEL-2001 has completed enrollment and the company expects to
announce top-line results in the second quarter of this year.
About Solabegron
Solabegron is a highly potent and selective beta-3 adrenoceptor agonist
being investigated for overactive bladder (OAB) and irritable bowel
syndrome (IBS). A Phase 2 study of solabegron in OAB, previously
conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258
patients with moderate to severe incontinence experiencing an average of
4.5 wet episodes per day. Results demonstrated a statistically
significant improvement with solabegron as compared to placebo.
Furthermore, the Phase 2 study also indicated a safety and tolerability
profile for solabegron that was similar to placebo.
About Velicept
Velicept Therapeutics, Inc. is a privately-held, clinical development
company focused on advancing best-in-class compounds for the treatment
of urological and gastrointestinal disorders. Its lead product,
solabegron, is a highly potent and selective beta-3 adrenoceptor agonist
being investigated for overactive bladder (OAB) and irritable bowel
syndrome (IBS). For more information, visit www.velicept.com.
Contacts
Media:
W2Otwist
Sheryl Seapy, (213) 262-9390
[email protected]