Minerva Announces Completion of Bridging Study to Select Improved Formulation of MIN-101 for Use in Phase 3 Trial for the Tre...
June 22 2017 - 8:30AM
New formulation observed to improve
safety margin while offering bioequivalent exposure to prior
formulation
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 α1-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.
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
Minerva Neurosciences (NASDAQ:NERV)
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