Market Overview

Velicept Therapeutics Initiates First of Two Phase 2b Dose-Ranging Studies of Solabegron in Patients with Overactive Bladder (OAB); Finalizes Novel, Once Daily Formulation; and Receives U.S. Patent Covering OAB


-First study has begun enrolling patients to evaluate twice-daily

-Second study to begin in the second quarter to assess once-daily dosing
with the novel QD formulation-

-Issuance of U.S. Patent No. 9,907,767 further expands Velicept's patent
portfolio covering Solabegron-

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 the
initiation of the first of two Phase 2b clinical studies. The first
study (VEL2002) will evaluate two doses of solabegron dosed twice daily
in patients with overactive bladder (OAB). The primary objective of the
study is to evaluate the mean change in number of micturitions per day
as measured by patients in an e-diary.

The Company has finalized a novel once daily formulation of solabegron
which will be evaluated in a second study. The formulation was
engineered to optimize efficacy in a convenient once daily dosing. This
study (VEL2001) will initiate patient enrollment in the second quarter
of this year.

Additionally the United States Patent and Trademark Office (USPTO) has
issued U.S. Patent No. 9,907,767, which is directed to methods related
to the use of solabegron to treat overactive bladder. The patent issued
with 42 claims directed to methods of treating overactive bladder,
measured by an increase in voided volume, using a therapeutically
effective amount of solabegron or its derivatives. This issued U.S.
Patent is part of a robust intellectual property portfolio that includes
numerous issued patents and pending patent applications in the U.S. and
major international markets directed to solabegron, its use for the
treatment of overactive bladder, once daily formulations designed to
optimize patient convenience and efficacy and methods of manufacture.

"We are pleased to be enrolling patients into the first of two dose
ranging studies. Driving the program forward with the novel once daily
formulation of solabegron as well as expanding our intellectual property
estate are key steps for Velicept as we work to deliver an optimal
therapy to patients suffering from OAB," said James Walker, President
and Chief Executive Officer, Velicept Therapeutics. "Many patients who
suffer from overactive bladder do not achieve adequate relief on
existing therapies, so we have designed our development program to
maximize potential treatment options for physicians and their patients."

The multicenter, randomized, double-blind, vehicle-controlled Phase 2b
study will enroll 375 adult women ages 18 to 80 with signs and symptoms
of overactive bladder from 90 centers across North America. Patients
will receive either 125mg or 175mg of solabegron twice daily or placebo
for 12 weeks.

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 II 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 II 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,

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