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MISSISSAUGA, ON, Sept. 18, 2017 /PRNewswire/ - Crescita Therapeutics Inc. (TSX: CTX) (Crescita or the Company), a Canadian commercial dermatology company with a portfolio of non-prescription skincare products and prescription drug products today announced that it has received positive topline results from a Phase 2 clinical trial (the Trial) in patients with plaque psoriasis (MiCal 1) conducted by its partner, Ferndale Laboratories, Inc. (Ferndale), in conjunction with a leading U.S. Contract Research Organization (CRO). The Trial demonstrated statistical significance in the achievement of its primary endpoint.
MiCal 1 is the first of two dermatological products being developed in collaboration with our partner. Under the terms of the collaboration, Crescita utilized its proprietary Multiplexed Molecular Penetration Enhancer Technology (MMPE™) to formulate two patented topical dermatology product candidates. It is anticipated that the product candidates will be made available for out-licensing at or before the completion of development. Licensing revenues would be shared between the parties, where Crescita's share would reflect its contribution of the patented formulations.
"We are excited by the positive results of this Phase 2 trial which studied the first developed formulation," said Serge Verreault, Crescita's President. "We believe that MiCal 1 can have a clinically meaningful benefit for the treatment of patients suffering from moderate to severe plaque psoriasis."
The TrialThe multi-centre, randomized, vehicle-controlled, double-blind, parallel group Phase 2 trial was conducted to determine and compare the efficacy and safety of MiCal 1 in the treatment of moderate to severe plaque psoriasis. The Trial was conducted at multiple U.S. study sites and enrolled 89 patients. The patients were randomly assigned on a double-blind basis to receive active or vehicle (the Control) formulations to treat their psoriasis in the designated treatment area twice daily for up to 28 days.
Primary EndpointThe primary efficacy endpoint of the Trial was the proportion of patients with Investigator's Global Assessment (IGA's) "treatment success" at the end of study after 28 days of treatment. 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. Successful achievement of the primary endpoint was defined as achieving an IGA score of 0 or 1 and a two-point move from their baseline assessment. The successful outcome was achieved in 17/89 (37.8%) of subjects in the active group compared to 3/89 (6.8%) of subjects in the vehicle group. This outcome was statistically significant. In addition, no unanticipated safety signals were noted in this Trial.
Next StepsThe Trial results will be evaluated in more detail to plan next steps in anticipation of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to further discuss the development of the product regarding advancement to Phase 3 as well as requirements for future FDA approval to market the product.
About Multiplexed Molecular Penetration Enhancer TechnologyThe MMPE technology uses synergistic combinations of pharmaceutical excipients included in the FDA's Inactive Ingredient Database 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 LaboratoriesFerndale Laboratories Inc., is a wholly owned subsidiary of the Ferndale Pharma Group (the Group). The Group comprises several independent subsidiary business units that are involved in researching, developing and delivering unique, value added skin care products designed to protect, heal, rejuvenate and beautify the skin.
Ferndale's business unit specializes in pharmaceutical development and manufacturing of topically administered prescription drugs, over-the-counter drugs, medical devices and cosmetics, including several New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) products. Ferndale's full-service Good Manufacturing Practice (GMP) facility performs analytical method and formulation development along with production scale-up for clinical trial supplies through to commercial batch manufacture, filling, packaging and distribution.
About Crescita Therapeutics Inc.Crescita (TSX:CTX) is a publicly traded, Canadian commercial dermatology company with a portfolio of non-prescription skincare products for the treatment and care of skin conditions and 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. For additional information, please visit www.crescitatherapeutics.com.
Forward-Looking StatementsThis Press Release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company's current beliefs, expectations and assumptions, the future of its business, future and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Crescita's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, readers should not rely on any of these forward-looking statements. Important factors that could cause Crescita's actual results and financial condition to differ materially from those indicated in the forward-looking statements include the risk factors included in Crescita's most recent Annual Information Form dated March 29, 2017 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 a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and none of Crescita or any other person assumes responsibility for the accuracy and completeness of these forward-looking statements.
Any forward-looking statement made by the Company in this Press Release is based only on information currently available to it and speaks only as of the date on which it is made. Except as required by applicable securities laws, Crescita undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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