New formulation observed to improve safety margin while
offering bioequivalent exposure to prior
formulation
Company to proceed with initiation of Phase 3 trial on
schedule in second half of 2017
CMC scale-up work for NDA preparation
initiated
WALTHAM, Mass., June 22, 2017 (GLOBE
NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a
clinical-stage biopharmaceutical company focused on the development
of therapies to treat central nervous system (CNS) disorders, today
announced the successful completion of a bridging trial to select
an improved, gastric-resistant (GR) formulation of MIN-101. The
Company plans to use the selected formulation in its upcoming Phase
3 clinical trial, which remains on schedule for initiation in the
second half of 2017, as well as for the potential future submission
of a New Drug Application (NDA).
The key objective of the bridging
study was to identify an improved formulation of MIN-101 that
would:
- Maintain similar exposure of MIN-101
based on area under the curve (AUC) as that shown in the Phase 2b
study, which achieved its primary endpoint of improving negative
symptoms in patients with schizophrenia with both doses tested, 64
milligrams (mg) and 32 mg;
- Reduce maximum concentration
(Cmax) of an
inactive metabolite of MIN-101 known as BFB-520, thereby reducing
the potential for transient QTc increases observed in the Phase 2b
study at the higher dose but not the lower dose;
- Eliminate food effect to allow the
Phase 3 doses to be administered with or without food.
In summary, data from the bridging
study of the selected new formulation demonstrated:
- Bioequivalent exposures of MIN-101
as measured by AUC;
- Reduction of Cmax of
BFB-520 by approximately 30% compared to the formulation used in
Phase 2b;
- No observations of QTc prolongations
throughout the study;
- No observable food effect, thus
allowing administration of the drug with or without food without
changing its pharmacokinetic properties;
- Confirmation of the overall safety
and tolerability profile of MIN-101.
"The successful completion of this
bridging study should allow us to initiate Phase 3 clinical testing
with MIN-101 on schedule in the second half of 2017 with the same
doses used in the Phase 2b trial, while potentially enhancing the
safety profile of MIN-101," said Dr. Remy Luthringer, president and
chief executive officer of Minerva. "The results from this study
should also help to ensure the coherent interpretation of results
from both the Phase 2b trial and the Phase 3 trial."
The Company plans to immediately
initiate CMC scale-up processes that will form part of the NDA in
the future. As exposures of MIN-101 in the Phase 2b study and the
formulation to be used in the forthcoming Phase 3 are comparable,
the Company believes data from both studies can be aggregated for
the purposes of evaluating efficacy. The Company has also
filed a patent application for the GR formulation, which is in
addition to an already granted patent in the U.S. that provides
protection until 2035. If granted, the additional patent
could potentially extend exclusivity beyond 2035.
The bridging study was an open-label,
randomized, 3-treatment sequence, 3-period study to evaluate the
plasma pharmacokinetic profile of MIN-101 and its metabolites
(BFB-520 and BFB-999) after single oral administration of three
formulations of MIN-101 (2 GR formulations and the formulation used
in Phase 2b) under fasted condition to healthy volunteers.
Upon completion of the 3-period testing, the GR formulation that
will be used in Phase 3 was then advanced and tested with food.
About MIN-101
MIN-101 is a drug candidate with
equipotent affinities for sigma2 and
5-hydroxytryptamine-2A (5-HT2A) and lower
affinity at Alpha1-adrenergic receptors. MIN-101 has no direct
dopaminergic post-synaptic blocking effects, known to be involved
in some side effects like extrapyramidal symptoms, sedation,
prolactin increases and weight gain.
The Phase 2b trial with MIN-101,
announced in 2016 and presented at the annual meeting of the
American College of Neuropsychopharmacology, met its primary
endpoint of statistically significant improvement in negative
symptoms as measured by the PANSS pentagonal structure model and in
the higher dose showed statistically significant benefit in
multiple secondary endpoints that included general
psychopathology.
MIN-101 is designed to improve
negative symptoms and cognitive impairment in schizophrenia,
thereby increasing the patient's ability to function socially and
vocationally while preventing the exacerbation of intermittent
positive symptoms.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a
clinical-stage biopharmaceutical company focused on the development
and commercialization of a portfolio of products to treat CNS
diseases. Minerva's proprietary compounds include: MIN-101,
in clinical development for schizophrenia; MIN-117, in clinical
development for major depressive disorder (MDD); MIN-202
(JNJ-42847922), in clinical development for insomnia and MDD; and
MIN-301, in pre-clinical development for Parkinson's disease.
Minerva's common stock is listed on the NASDAQ Global Market under
the symbol "NERV." For more information, please
visit www.minervaneurosciences.com.
Forward-Looking Safe
Harbor Statement
This press release contains forward-looking statements
which are subject to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts, reflect management's expectations as of the date of this
press release, and involve certain risks and uncertainties.
Forward-looking statements include statements herein with respect
to: the improved formulation of MIN-101 to be used in the planned
Phase 3 trial of MIN-101; the timing and results of future clinical
milestones with MIN-101, including the planned Phase 3 trial of
MIN-101, the timing and scope of future clinical trials and results
of clinical trials with this compound; the potential for a single
Phase 3 trial with supportive Phase 2b results to support the basis
for an NDA; the timing and outcomes of future interactions with
U.S. and foreign regulatory bodies; our ability to successfully
develop and commercialize MIN-101; the sufficiency of our current
cash position to fund our operations; and management's ability to
successfully achieve its goals. These forward-looking
statements are based on our current expectations and may differ
materially from actual results due to a variety of factors
including, without limitation, whether MIN-101 will advance further
in the clinical trials process and whether and when, if at all, it
will receive final approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies and for
which indications; whether the results of future clinical trials of
MIN-101, if any, will be consistent with the results of past
clinical trials; whether MIN-101 will be successfully marketed if
approved; whether any of our therapeutic product discovery and
development efforts will be successful; our ability to achieve the
results contemplated by our co-development agreements; management's
ability to successfully achieve its goals; our ability to raise
additional capital to fund our operations on terms acceptable to
us; and general economic conditions. These and other
potential risks and uncertainties that could cause actual results
to differ from the results predicted are more fully detailed under
the caption "Risk Factors" in our filings with the Securities and
Exchange Commission, including our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2017, filed with
the Securities and Exchange Commission on May 4,
2017. Copies of reports filed with the SEC are
posted on our website at www.minervaneurosciences.com. The forward-looking statements in this
press release are based on information available to us as of the
date hereof, and we disclaim any obligation to update any
forward-looking statements, except as required by law.