CollaGenex Pharmaceuticals Announces Positive Results of Phase 2 Dose-Finding Study of Incyclinide for the Treatment of AcneNEWTOWN, Pa.--(BUSINESS WIRE)--Mar 1, 2007 - CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced results of a Phase 2 dose-finding study designed to evaluate the safety and determine the therapeutic range of incyclinide for the treatment of acne. The study achieved its objectives and demonstrated an excellent side effect profile similar to placebo. A clear dose-response relationship was also observed. While the study was not powered for statistical significance, incyclinide showed a statistically significant clinical benefit compared to placebo at certain dosages and time points during the study. The study determined the minimum effective incyclinide dose for the treatment of acne, which was 10 mg per day, and greater efficacy was observed at 20 mg per day. CollaGenex will continue the dose optimization trial and initiate an additional cohort with the objective to determine the maximum effective dose.
The Company will host a conference call and webcast today at 11:00 a.m. Eastern Time to discuss these results. Additional details about the call are provided below.
Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "We are extremely encouraged that our Phase II dose-finding study demonstrated a dose-response relationship for incyclinide in the treatment of acne. We established a minimum effective dose at 10 mg per day and saw greater efficacy at a 20 mg daily dose. The drug appears to be safe and effective at a 20 mg daily dose with a side effect profile similar to placebo. We do not believe that we have seen peak efficacy yet. Therefore, we will shortly initiate an additional cohort at a dose greater than 20 mg, subject to FDA approval. This cohort is planned to enroll a total of 100 patients and should be completed during the fourth quarter of this year."
Guy Webster, M.D., Ph.D., Clinical Professor of Dermatology, Jefferson Medical College, and a member of the CollaGenex Scientific Advisory Board, commented, "A 20 mg daily dose of incyclinide delivered a therapeutic benefit similar to that seen with other acne drugs with side effects similar to placebo. I have every reason to believe that a higher dosage will result in even greater efficacy."
Colin Stewart, president and chief executive officer of CollaGenex, stated, "The results of this trial provide significant evidence that incyclinide offers clinical benefits in the treatment of acne with side effects similar to placebo. We anticipate concluding our Phase II dose-ranging study later this year and initiating Phase III clinical trials of incyclinide in acne patients in the first quarter of 2008. We continue to be very excited about the potential of incyclinide to be the first new compound approved to treat acne in over 20 years."
The double-blind, placebo-controlled trial enrolled a total of 302 acne patients at 27 centers. The patients were divided among four arms of the study and administered either a placebo capsule or a 5 mg or 10 mg or 20 mg incyclinide capsule. Patients were enrolled in three sequential cohorts, each consisting of an active treatment group and a smaller placebo group. The first cohort received the lowest dose of 5 mg incyclinide and each subsequent cohort escalated to the next higher dose level of 10 mg and 20 mg, respectively. The total number of placebo patients across the three cohorts was approximately the same as each of the active treatment groups. Study-wide and in-cohort placebo analyses were conducted to detect possible effects of the seasons on the placebo response. Absent treatment, acne patients typically improve during the summer months and worsen during the winter months.
Each cohort of the study was administered either a placebo or incyclinide capsule once a day for 12 weeks. The primary endpoint of the study was the reduction in inflammatory lesion count at 12 weeks. Patients were evaluated at Baseline, Weeks 3, 6, 9, 12 and 16 (four weeks after the final capsule was administered). The average number of inflammatory lesions at baseline was approximately 24 and well-balanced across the four treatment arms.
Incyclinide was well-tolerated with most adverse events being mild or moderate. The adverse events were equally distributed across all treatment groups, including placebo. Laboratory and clinical safety assessments were unremarkable.
Efficacy was assessed in an Intent-To-Treat analysis comparing the lesion count profile over the course of the study. No apparent drug effect was observed in the 5 mg patient cohort at any visit. In the 10 mg patient group, a drug effect was observed compared to both the total placebo group and the in-cohort placebo group.
The 20 mg patient cohort showed the greatest reduction in inflammatory lesions compared to placebo, with a rapid onset of action. This cohort had a 25.9% reduction in inflammatory lesion count at Week 3 compared to a 9.4% effect in the in-cohort placebo group. At Weeks 6, 9 and 12, the reductions in inflammatory lesions for the incyclinide group were 36.0%, 36.1% and 31.7%, respectively, compared to 17.5%, 23.8% and 26.5%, respectively, for the in-cohort placebo group. At Weeks 3 and 6, the data showed a trend towards statistical significance, with p values less than 0.07.
When compared to the total placebo group, the reductions in inflammatory lesions in the 20 mg cohort were statistically significant at Weeks 6 (p=0.041) and 9 (p=0.037). The greatest reduction in inflammatory lesion count occurred at Week 9 and was less apparent at Week 12.
A secondary endpoint of the study evaluated the change in the Investigator's Global Assessment (IGA) score, a subjective measurement of disease severity. As with the inflammatory lesion count, the 5 mg cohort could not be differentiated from the total placebo group. The 10 mg cohort showed a statistically significant but modest improvement in the IGA score compared to the total placebo group at Week 9 (p=0.022), and the 20 mg group showed a greater improvement in the IGA score compared to the total placebo group at Week 6 (p=0.065) and Week 9 (p=0.026). The performance of the three cohorts compared to placebo in the change in IGA score further confirmed the dose-relationship across the three incyclinide cohorts.
Conference Call Information
CollaGenex will hold a conference call today, March 1, 2007, at 11:00 a.m. Eastern Time to discuss the results announced in this release. Investors and other interested parties may access the conference call by dialing (888) 321-3075 in the U.S. or (973) 582-2855 internationally, or via a live webcast on the company's website at www.collagenex.com.
For those who cannot listen to the live webcast, a replay will be available shortly after the call at www.collagenex.com for 90 days. Additionally, a recording of the call will be available by telephone until 11:59 p.m. on March 8, 2007 by dialing (877) 519-4471 in the U.S. or (973) 341-3080 internationally, and entering access code: 8503713.
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing innovative proprietary medical therapies to the dermatology market. In July 2006, CollaGenex launched Oracea(TM), the first FDA-approved systemic product for the treatment of rosacea. CollaGenex is also conducting Phase I clinical trials to evaluate COL-118, a topical compound based on the SansRosa(TM) technology, for the treatment of redness associated with rosacea and other skin disorders. CollaGenex's professional dermatology sales force also markets Pandel(R), a prescription topical corticosteroid licensed from Altana, Inc., Alcortin(TM) (1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal steroid combination, and Novacort(TM) (2% hydrocortisone acetate and 1% pramoxine HCl), a prescription topical steroid and anesthetic. Alcortin and Novacort are marketed by the Company under a Promotion and Cooperation agreement with Primus Pharmaceuticals, Inc.
Research has shown that new compounds can be created by chemically modifying certain tetracyclines and that these new compounds have properties that may make them effective in treating diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is evaluating various of these compounds (so called "IMPACS(TM)" compounds because they are Inhibitors of Multiple Proteases And CytokineS) to assess whether they are safe and effective in these applications. The Company has a pipeline of innovative product candidates with possible applications in dermatology and other disease states. In addition, CollaGenex has acquired the Restoraderm(R) technology, a unique, proprietary dermal drug delivery system, and plans to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.
To receive additional information on the Company, please visit our Web site at www.collagenex.com, which does not form part of this press release.
Forward Looking Statements
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the clinical results and commercial potential of Oracea, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. CollaGenex's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in the most recent Form 10-Q for the quarter ended September 30, 2006 under the section "Risk Factors" as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding CollaGenex's expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. CollaGenex assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Restoraderm(R) is a registered trademark and IMPACS(TM), SansRosa(TM) and Oracea(TM) are trademarks of CollaGenex Pharmaceuticals, Inc.
MetroGel(R) is a registered trademark of Galderma Laboratories, Inc.
Novacort(TM) and Alcortin(TM) are trademarks of Primus Pharmaceuticals, Inc.
Pandel(R) is a registered trademark of Taisho Pharmaceuticals.
All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.
CollaGenex Pharmaceuticals, Inc.
Nancy C. Broadbent, 215-579-7388
Evan Smith, CFA / Erica Pettit
212-850-5606 / 212-850-5614
Posted: March 2007