Mr. Serge Verreault reports

CRESCITA THERAPEUTICS REPORTS POSITIVE TOPLINE RESULTS OF PHASE 2 CLINICAL TRIAL FOR THE TREATMENT OF PLAQUE PSORIASIS

Crescita Therapeutics Inc. has received positive top-line results from a phase 2 clinical trial in patients with plaque psoriasis (MiCal 1) conducted by its partner, Ferndale Laboratories Inc., in conjunction with a leading U.S. contract research organization (CRO). The trial demonstrated statistical significance in the achievement of its primary end point.

MiCal 1 is the first of two dermatological products being developed in collaboration with the company's 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 outlicensing 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 trial

The multicentre, 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 end point

The primary efficacy end point 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 end point was defined as achieving an IGA score of zero or one and a two-point move from their baseline assessment. The successful outcome was achieved in 17/89 (37.8 per cent) of subjects in the active group compared with three/89 (6.8 per cent) of subjects in the vehicle group. This outcome was statistically significant. In addition, no unanticipated safety signals were noted in this trial.

Next steps

The 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 technology

The 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 Crescita Therapeutics Inc.

Crescita is a publicly traded, Canadian commercial dermatology company with a portfolio of non-prescription skin care 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.

We seek Safe Harbor.