Intrepid Therapeutics Announces Development Agreement with Cosmo Pharmaceuticals

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IND for Acne Indication for CB-03-01 Accepted by FDA

Intrepid Therapeutics, Inc., a specialty pharmaceutical company based in San Diego focused on the development of innovative prescription products for dermatological indications, announced that it has entered into an agreement with Cosmo Pharmaceuticals (SIX: COPN) to conduct the Phase II clinical trials in the US for Cosmo’s novel topical anti-androgen molecule, CB-03-01 (cortexolone 17α-propionate). Intrepid Therapeutics also announced that the Investigational New Drug Application (IND) for CB-03-01 for acne has been accepted by the Food and Drug Administration (FDA) and the company will now proceed with a double-blind, randomized, placebo-controlled Phase II clinical trial in acne. Acne represents the most common skin disease, affecting 85% of teenagers, and 40-50 million people in the U.S.

“This agreement with Cosmo and the acceptance of the IND allow us to move forward with the rare opportunity to develop a new and innovative molecule for the dermatology market,” said Diane S. Goostree, Intrepid’s President and CEO. “We are extremely encouraged by the data generated to date with this novel drug, and look forward to conducting this large Phase II trial in patients with acne in the US. We are also conducting further non-clinical studies to prepare for an additional IND filing and clinical studies to evaluate CB-03-01 in the treatment of androgenic alopecia (hair loss).”

Previously, a European Phase II pilot study with CB-03-01 demonstrated positive results in a three arm, randomized, double-blind, parallel-group, controlled study versus placebo and versus Retin-A® 0.05% cream, in facial acne vulgaris. The trial showed that CB-03-01 was clinically superior to placebo and to Retin-A® 0.05% cream in the treatment of facial acne vulgaris after 8 weeks of drug application

About the Phase II Acne Study

The Phase II acne study is designed as a multi-center, double-blind, placebo controlled, dose-escalating study to evaluate the safety and efficacy of CB-03-01 in the treatment of patients with mild to moderate facial acne vulgaris. The clinical trial is intended to enroll approximately 360 patients, with a 12 week treatment period. Primary endpoints include the proportion of patients achieving success, based on the Investigator Global Assessment (IGA) scale, and the absolute change from baseline for inflammatory and non-inflammatory lesion counts at 12 weeks. Secondary endpoints include the proportion of patients achieving success based on the IGA at 8 weeks, and lesion counts at 8 weeks.

About CB-03-01

CB-03-01 is a molecule that acts at the level of the skin androgen receptor, blocking testosterone (T) and dihydrotestosterone (DHT) from binding to the receptor in the cell. The molecule has a unique mechanism that acts at the skin surface, and is quickly metabolized to free inactive cortexolone, a substance naturally found in the body. The molecule has been evaluated in a variety of animal models as well as initial human trials in Europe for acne and androgenic alopecia. The results of these studies demonstrate that CB-03-01 appears to have potent anti-androgenic activity without significant local or systemic side effects.

About Intrepid Therapeutics

Intrepid Therapeutics, Inc. is an independent, privately owned specialty pharmaceutical company based in San Diego, California, involved in licensing and developing innovative prescription drugs for dermatological conditions. More information about Intrepid Therapeutics is available at http://www.intrepidthera.com.

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal and topically treated Skin Disorders. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company is developing a new chemical entity for the topical treatment of Acne, Alopecia and Hirsutism. Cosmo’s first MMX® product that has reached the market is Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the intestines. For further information on Cosmo, please visit http://www.cosmopharma.com

Contact

Diane S. Goostree, President and CEO
Intrepid Therapeutics, Inc.
Phone: (858) 735-0387
http://intrepidthera.com
info(at)intrepidthera(dot)com

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Diane Goostree
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