VIVUS Announces Positive Results from a Phase 1 Clinical Trial of VI-0106
July 10 2018 - 07:30AM
-Favorable pharmacokinetic results add to
body of data supporting continued development in the treatment of
pulmonary arterial hypertension-
VIVUS, Inc. (Nasdaq:VVUS) (the “Company”), a biopharmaceutical
company, today announced positive preliminary results from a Phase
1 clinical study evaluating the pharmacokinetic (PK) profile of its
VI-0106 in healthy volunteers. VIVUS is developing VI-0106, a
proprietary soft capsule formulation of tacrolimus for the
treatment of pulmonary arterial hypertension (PAH), a degenerative
disease that makes it difficult for the heart to pump blood through
the lungs to be oxygenated and may ultimately lead to heart
failure.
Current PAH treatment options only address the
symptoms, slowing but not preventing disease progression. New
therapies that address the underlying cause of disease are urgently
needed. The U.S. Food and Drug Administration
(FDA) approved tacrolimus in 1994 for use in lowering the risk
of organ rejection in patients undergoing kidney transplant, and
the drug is currently indicated for use in additional organ
transplant settings and to treat atopic dermatitis.
Tacrolimus has been shown to increase signaling through the
bone morphogenetic protein receptor 2 (BMPR2) pathway, which is
down-regulated in PAH patients.
“The positive Phase 1 data from this study of
VI-0106 in healthy volunteers support continued evaluation of this
investigational candidate in PAH patients,” said John Amos, Chief
Executive Officer at VIVUS. “The worldwide and U.S. markets
for PAH therapies were approximately $4.5 billion and $2.7 billion,
respectively, in 2015, and we believe that VI-0106 has the
potential to capture significant market share as a first-in-class
therapy with a novel mechanism of action. We are exploring a
variety of strategies for leveraging this collection of data to
advance this program consistent with our goals of working toward
profitability and reducing our corporate debt.”
The single-center, UK-based Phase 1 PK study was
conducted in two parts. Sixteen healthy volunteers were
enrolled in Part 1 and each patient sequentially received single
doses of three different tacrolimus prototype regimens administered
at least 10 days apart. An interim analysis was conducted
following the third dosing period to select a formulation prototype
with the most desirable PK profile. Three subsequent periods
assessed the selected formulation at different doses, or under
different fed/fasted conditions. The second part of the study
evaluated steady-state PK parameters in 12 healthy volunteers
receiving daily doses of the selected prototype formulation.
Dr. Santosh T. Varghese, MD Chief Medical
Officer at VIVUS stated, “The key findings from the Phase 1 PK
study show that prototype formulations had PK profiles consistent
with earlier in-vitro evaluations, namely an extended Tmax, a
lowered Cmax, and an increased AUC compared to available immediate
release tacrolimus. Moreover, data from this study demonstrate that
once-daily dosing of VI-0106 may facilitate maintenance of the low
tacrolimus concentrations required for the treatment of PAH with
minimal monitoring of drug levels.” Dr. Varghese further added,
“Based on the ongoing COMPERA registry study, the five-year
survival rate for high risk PAH patients is 22.8%. We are
hopeful that VI-0106 can be added to the therapeutic options for
patients and their treating physicians.”
VIVUS is developing VI-0106 under the FDA’s
505(B)(2) regulatory pathway, which will allow the Company to
leverage the FDA’s finding of safety and effectiveness for
tacrolimus as well as a significant body of previously published
tacrolimus safety and efficacy data. This is expected to
reduce the time and cost to develop VI-0106 as a potential
breakthrough therapy for the treatment of PAH.
In September 2017, results of a
university-run Phase 2a clinical study of tacrolimus in patients
with PAH were published in the European Respiratory Journal.
Study results demonstrate the safety of tacrolimus in patients with
PAH.
The currently approved formulation of VI-0106
tacrolimus was also provided for compassionate use in three class 3
or 4 PAH patients. The compassionate use demonstrated dramatically
reduced rates of hospitalizations and functional class improvements
were observed.
VIVUS believes that VI-0106 could become an
important new treatment option for PAH patients and intends to
request both Fast Track and Breakthrough Therapy Designation from
the FDA for VI-0106 in this indication. Breakthrough therapy
designation is intended to expedite the development and review of
drugs for serious or life-threatening conditions. The criteria for
breakthrough therapy designation require preliminary clinical
evidence that demonstrates the drug may have substantial
improvement on at least one clinically significant endpoint over
available therapy.
About Pulmonary Arterial Hypertension
(PAH)
PAH is a chronic life-threatening disease
characterized by endothelial dysfunction in the pulmonary
vasculature, resulting in excess smooth muscle proliferation,
elevated blood pressure in the pulmonary arteries (arteries between
the heart and lungs), and ultimately right-sided heart
failure. The symptoms of PAH are non-specific and can range
from mild shortness of breath and fatigue during normal daily
activity to symptoms of right heart failure and severe restrictions
on exercise capacity, and ultimately reduced life expectancy.
PAH includes patients with idiopathic PAH, familial PAH, and
associated PAH, which is related to certain conditions including
connective tissue diseases, congenital
systemic-to-pulmonary-shunts, portal hypertension, HIV infection,
drugs and toxins. The current treatments for PAH involve
calcium channel antagonists, prostacyclins, prostacyclin receptor
(IP receptor) agonist, endothelin receptor antagonists,
phosphodiesterase-5 (PDE5) inhibitors, soluble guanylate cyclase
stimulators, and long-term anticoagulant therapy, with the aim to
reduce symptoms and improve quality of life.
About VIVUS
VIVUS is a biopharmaceutical company committed
to the development and commercialization of innovative therapies
that focus on advancing treatments for patients with serious unmet
medical needs. For more information about the Company, please
visit www.vivus.com.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to potential change in our business strategy to enhance
long-term stockholder value, including the acquisition of revenue
generating products and the strengthening of our balance sheet;
risks and uncertainties related to our ability to address or reduce
our outstanding balance of the convertible notes due in 2020; risks
and uncertainties related to our expected future revenues,
operations and expenditures; risks and uncertainties related to our
ability to successfully develop or acquire a proprietary
formulation of tacrolimus as a precursor to the clinical
development process; risks and uncertainties related to our ability
to identify, acquire and develop new product pipeline candidates;
risks and uncertainties related to our ability to develop a
proprietary formulation and to demonstrate through clinical testing
the quality, safety, and efficacy of our current or future
investigational drug candidates; and risks and uncertainties
related to the failure to obtain FDA or foreign authority
clearances or approvals and noncompliance with FDA or foreign
authority regulations. These risks and uncertainties could
cause actual results to differ materially from those referred to in
these forward-looking statements. The reader is cautioned not
to rely on these forward-looking statements. Investors should read
the risk factors set forth in VIVUS’ Form 10-K for the year ended
December 31, 2017 as filed on March 14, 2018, and as amended by the
Form 10-K/A filed on April 26, 2018, and periodic reports filed
with the Securities and Exchange Commission. VIVUS does not
undertake an obligation to update or revise any forward-looking
statements.
|
|
VIVUS,
Inc. |
Investor
Relations: Lazar Partners |
Mark Oki |
David Carey |
Chief Financial
Officer
|
Managing Director |
oki@vivus.com |
dcarey@lazarpartners.com |
650-934-5200 |
212-867-1768 |
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