Primary Endpoint Achieved with High Statistical Significance
LAVAL, QC, Feb. 11, 2020 /PRNewswire/ – 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.
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.
SOURCE Crescita Therapeutics Inc.