Primary Endpoint Achieved with High
Statistical Significance
LAVAL, QC, Feb. 11, 2020 /CNW/ – Crescita Therapeutics Inc.
(TSX: CTX) (OTC US: CRRTF) ("Crescita" or the "Company"), a
commercial dermatology company with manufacturing capabilities and
a portfolio of non-prescription skincare products and prescription
drug products for the treatment and care of skin conditions,
diseases and their symptoms, today announced positive topline
results from two pivotal Phase 3 clinical trials for an
ultra-potent topical corticosteroid product being developed for the
treatment of plaque psoriasis using the Company's patented
Multiplexed Molecular Penetration Enhancer ("MMPE™") technology.
The studies were conducted by the Company's partners including
Ferndale Laboratories, Inc. ("Ferndale").
The two Phase 3 multi-centre, randomized, vehicle-controlled,
double-blind, parallel group trials were conducted in the United States using the same study design.
Both studies met the primary endpoint demonstrating that a
statistically significant greater number of patients achieved the
Investigator's Global Assessment ("IGA's") treatment success (p<
0.001) at the end of study. The IGA score is a static evaluation by
the investigator of the overall assessment of the patient's disease
status within the designated treatment area. These results are
based on the Intent To Treat ("ITT") population and study results
in the Per Protocol ("PP") population were also highly significant
as were key secondary endpoints for both studies.
Serge Verreault, Crescita's
President and CEO commented: "These impressive study results
support our continued belief that this product can have a
clinically meaningful benefit for the treatment of patients
suffering from moderate to severe plaque psoriasis."
This is the first of two dermatological products being developed
in collaboration with our partners. Under the terms of the
collaboration, Crescita utilized its proprietary MMPE™ technology
to formulate two patented topical dermatology product
candidates.
About Crescita Therapeutics Inc.
Crescita (TSX: CTX
and OTC US: CRRTF) is a publicly traded, Canadian commercial
dermatology company with manufacturing capabilities and a portfolio
of non-prescription skincare products for the treatment and care of
skin conditions, diseases and their symptoms and prescription drug
products for the treatment of pain. Crescita owns multiple
proprietary drug delivery platforms that support the development of
patented formulations that can facilitate the delivery of active
drugs into or through the skin.
Supported by a sales force covering Canada and executing its business to business
to consumer marketing approach, Crescita sells its non-prescription
products through spas, medispas and medical clinics. In addition,
our brands and formulations are currently sold in the U.S. and
certain Asian markets through international distributors as well as
through a leading cross-border e-commerce channel in China.
Crescita developed a prescription product called
Pliaglis® that utilizes our proprietary
phase-changing topical cream Peel technology. Pliaglis is a topical
local anaesthetic cream that provides safe and effective local
dermal analgesia on intact skin prior to superficial dermatological
procedures. The product is currently approved in over 25 different
countries and sold by commercial partners in the U.S., Italy and Brazil.
Crescita also provides contract development and manufacturing
services to several local and North American clients. Our contract
development and manufacturing organization infrastructure allows
Crescita to provide its clients with development and other support
activities required to bring their products to market. Crescita has
extensive expertise in product formulation and development,
leveraging our patented transdermal delivery technologies, and
specializes in manufacturing creams, liquids, gels ointments and
serums. The Company operates out of a 50,000 square-foot
manufacturing facility located in Laval, Québec that is compliant with current
Canadian Good Manufacturing Practices and is regularly inspected by
Health Canada.
About MMPE™
The MMPE technology uses synergistic
combinations of certain pharmaceutical excipients included on the
FDA's Inactive Ingredient Guide for improved topical delivery of
active pharmaceutical ingredients ("APIs") into or through the
skin. The benefits of this technology include the potential
for increased penetration of APIs with the possibility of improved
efficacy, lower API concentration and/or reduced dosing. Issued
U.S. patents provide intellectual property protection
through March 6, 2027.
About Ferndale Laboratories
Ferndale Laboratories
Inc., is a wholly owned subsidiary of the Ferndale Pharma Group.
Ferndale is a full-service turn-key CMC service provider for
semi-solid and liquid Rx and OTC drug products. They offer
formulation development and optimization, pivotal exhibit batch
production, clinical trial supplies, ICH stability programs and
scale-up to validated commercial batch production. Their analytical
laboratory capabilities include method development and validation
for HPLC, UPLC, GC, IVRT, various wet chemistry methods and
microbiologic testing. They can compound commercial bulk batch
quantities or clinical trial materials and offer packaging in
laminate, plastic or aluminum tubes as well as various sizes of
plastic bottles with secondary packaging that includes
serialization and aggregation.
Forward-Looking Information Cautionary Statement
This
press release contains "forward-looking information" as defined
under Canadian securities laws (collectively, "forward-looking
statements"). The words "plans", "expects", "does not expect",
"goals", "seek", "strategy", "future", "estimates", "intends",
"anticipates", "does not anticipate", "projected", "believes" or
variations of such words and phrases or statements to the effect
that certain actions, events or results "may", "will", "could",
"would", "should", "might", "likely", "occur", "be achieved" or
"continue" and similar expressions identify forward-looking
statements. In addition, any statements that refer to expectations,
intentions, projections or other characterizations of future events
or circumstances contain forward-looking statements.
Forward-looking statements are not historical facts but instead
represent management's expectations, estimates, projections and
assumptions regarding future events or circumstances. Such
forward-looking statements are qualified in their entirety by the
inherent risks, uncertainties and changes in circumstances
surrounding future expectations which are difficult to predict and
many of which are beyond the control of the Company.
Forward-looking statements are necessarily based on a number of
estimates and assumptions that, while considered reasonable by
management of the Company as of the date of this press release, are
inherently subject to significant business, economic and
competitive uncertainties and contingencies. Material factors and
assumptions used to develop the forward-looking statements, and
material risk factors that could cause actual results to differ
materially from the forward-looking statements, include but are not
limited to changes in the business or affairs of Crescita; the
ability of Crescita's licensees to successfully market its
products; competitive factors in the industries in which Crescita
operates; relationships with customers, suppliers and licensees;
changes in legal and regulatory requirements; foreign exchange and
interest rates; prevailing economic conditions; and other factors,
many of which are beyond the control of Crescita.
Additional factors that could cause Crescita's actual results
and financial condition to differ materially from those indicated
in the forward-looking statements include, among others, the risk
factors included in Crescita's most recent Annual Information Form
dated March 18, 2019 under the heading "Risks Factors",
and as described from time to time in the reports and disclosure
documents filed by Crescita with Canadian securities regulatory
agencies and commissions. These and other factors should be
considered carefully, and readers should not place undue reliance
on Crescita's forward-looking statements, as forward-looking
statements involve significant risks and uncertainties.
Forward-looking statements should not be read as guarantees of
future performance or results and will not necessarily be accurate
indications of whether or not the times at or by which such
performance or results will be achieved.
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SOURCE Crescita Therapeutics Inc.