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Derma Sciences Provides Update on Aclerastide Phase 3 Trials
[May 19, 2015]

Derma Sciences Provides Update on Aclerastide Phase 3 Trials


Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration company focused on advanced wound and burn care, reports the halfway point of enrollment in the Phase 3 program with aclerastide (DSC127) in subjects with diabetic foot ulcers. The clinical trial sites contributing at this time are from the U.S. (including Puerto Rico), Canada and South Africa. The Company is taking solid steps toward accelerating screening and enrollment by opening additional sites in Eastern Europe, Germany and potentially Israel.

Derma Sciences has targeted the end of June 2016 for the last subject to be randomized in the pivotal program. Database lock will occur within a couple of months after the last subjects complete the 24 weeks of study participation. Top-line results should be available within a few weeks after database lock.

Commenting on the trials' progress, John Caminis, M.D., Derma Sciences chief medical officer, said, "We are pleased to have reached this important milestone in our pivotal Phase 3 program. This is the largest ongoing randomized controlled trial in diabetic foot ulcers and the most rigorous in recent years. Despite the complexities and associated co-morbidities of our patient population, we have achieved a steady recruitment rate and anticipate maintaining this momentum as we add new sites outside the U.S. We expect to enroll the first subject from these new sites in September."

According to Edward J. Quilty, Derma Sciences chairman and chief executive officer, "We are very excited with the progress we are now making with enrolling our aclerastide trial. There are as many as 1.5 million people in the U.S. alone suffering from diabetic foot ulcers, and there are no new pharmaceutical options for treating their wounds at present. We look forward to the potential of offering patients and their health care providers a new therapeutic solution with aclerastide."

"In addition to opening new clinical trial sites overseas, Derma Sciences is conducting a comprehensive review of existing sites with the goal of improving enrollment. We remain assertive and thoughtful with the handling of our trial sites," added Dr. Caminis. "While our immediate goal is accelerating enrollment, we are committed to the rigorous conduct of all aspects of the Phase 3 program in order to ensure continued patient safety, quality and data integrity."

About the Aclerastide Phase 3 Program

Derma Sciences expects to enroll up to 1,055 subjects across two trials. The first will evaluate aclerastide 0.03% against a topical vehicle, similar to the design of the completed Phase 2 trial. The second will evaluate clerastide 0.03% against a topical vehicle and against a standard of care hydrogel dressing. Throughout the course of both trials subjects will receive standard of care, including debridement, cleansing, maintenance of a moist wound environment and an off-loading device.



After a 14-day run-in period, subjects with wounds that have not closed by more than 30% will be randomized, in a blinded fashion, into one of five arms across the two trials. Subjects will receive the study drug or vehicle in the two-arm trial; and study drug, vehicle or placebo hydrogel in the three-arm trial once daily for four weeks. Subjects will then receive standard of care only and followed for up to six additional weeks to until complete wound closure is achieved. If the ulcer is confirmed closed, subjects will continue to receive standard of care and will be observed for up to 12 more weeks to determine the durability of the healing. The primary endpoint of the Phase 3 trials is the proportion of ulcers completely closed by 10 weeks and remaining completely closed two weeks later. Key secondary endpoints include rate of closure and safety.

In addition, a safety study allowing for multiple courses of therapy is well underway, and will include subjects from the pivotal trials as well as new subjects. This study will assess the safety of aclerastide with repeated courses of treatment of up to 12 weeks at a time. To date 120 subjects have been enrolled in this study.


Further information may be found at www.clinicaltrials.gov.

About Derma Sciences, Inc.

Derma Sciences is a tissue regeneration company focused on advanced wound and burn care. It offers a line of products with patented technologies to help better manage chronic and hard-to-heal wounds, many of which result from diabetes and poor vascular functioning. The Company sells AMNIOEXCEL® amniotic allograft membrane and AMNIOMATRIX® amniotic allograft suspension into the $500 million market for skin substitute products. Derma Sciences' MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. TCC-EZ® is a gold-standard total contact casting system for diabetic foot ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants. Its pharmaceutical wound care products include aclerastide (a patented peptide analog of angiotensin), currently in Phase 3 clinical trials for the healing of diabetic foot ulcers. Aclerastide is also in preclinical testing for scar prevention/reduction and is part of a BARDA grant program for the healing/prevention of skin tissue damage associated with exposure to ionizing radiation. The Company also offers a full product line of traditional dressings.

For more information please visit www.dermasciences.com.

Forward-Looking Statements

Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company's results include, but are not limited to development and commercialization of aclerastide (DSC127), product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission.


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