Endo Announces Initiation Of Two Pivotal Phase 3 Clinical Trials Of Collagenase Clostridium Histolyticum For The Treatment Of Cellulite
DUBLIN, Feb. 6, 2018 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced the initiation of two identical Phase 3 RELEASE* clinical trials of collagenase clostridium histolyticum (CCH) for the treatment of cellulite. The multicenter, randomized, double-blind, placebo-controlled RELEASE studies will evaluate the safety and efficacy of CCH in reducing the appearance of cellulite.
"Despite the number of options currently marketed as cellulite remedies, there still are no U.S. Food and Drug Administration (FDA)-approved pharmacologic treatments, and patients continue to seek new, effective, non-surgical treatment options to reduce the appearance of cellulite," said Matthew W. Davis, M.D., RPh., Chief Medical Officer and Senior Vice President, Research and Development at Endo Pharmaceuticals. "Endo understands the social stigma and psychological impact that cellulite can have on patients, and these Phase 3 RELEASE studies represent our commitment to identifying the full potential of this therapy through our clinical development program. This is an important step in our goal to provide a new treatment option for appropriate patients with cellulite."
The Phase 3 RELEASE studies are expected to enroll 840 women (420 in each trial) aged 18 years or older with moderate to severe cellulite in the United States. Each subject will receive up to three treatment visits of CCH (0.84 mg / treatment area, two treatment areas per visit) or placebo, with each treatment visit occurring approximately 21 days apart. Twelve injections will be administered into cellulite dimples during each visit across each treatment area – the left and right buttock. At both the outset and conclusion of treatment, cellulite severity will be assessed by each patient and clinician using two validated photonumeric cellulite severity scales developed by Endo and third-party psychometric experts.
The primary endpoint is a composite responder analysis demonstrating at least a 2-level composite improvement, independently reported by both patient and clinician on the photonumeric scales of cellulite severity. Key secondary endpoints include the percentage of subjects that experience at least a 1-level or 2-level improvement in patient reported assessment, percentage of subjects with a 1-level composite improvement, percentage of satisfied subjects, change from baseline in a cellulite impact scale, i.e., patients' self-perception related to their cellulite, as well as the percentage of subjects with at least a 1-level or 2-level improvement in the global aesthetic improvement scale (GAIS).
"Patients who seek treatment for cellulite often report that the condition negatively affects their self-image," said Sabrina Fabi, M.D., a double-board certified dermatologist and dermatologic cosmetic surgeon at Cosmetic Laser Dermatology in San Diego, CA. "As a practicing dermatologist, I am always looking for different, well-tolerated and non-surgical treatment options that may help address the needs of my patients. The start of the Phase 3 RELEASE studies is exciting because we need more research in the area of cellulite treatment."
In an earlier Phase 2b trial of CCH for the treatment of cellulite, CCH was well-tolerated by all dose groups with most adverse events (AEs) being mild to moderate and primarily limited to the local injection area. The most common AEs in the trial were injection site bruising, injection site pain, nodule/mass, pruritus, swelling and induration at the injection sites.
About Cellulite
Cellulite is a localized alteration in the contour of the skin that has been reported in 85 to 98 percent of post-pubertal females and affects women of all races and ethnicities.i,ii The primary cause of the condition is a thickening of the collagen septae that attach the skin to the underlying fascia layers with additional contributing protrusions of subcutaneous fat. The septae tether the skin, which causes the surface dimpling characteristic of cellulite.ii,iii CCH is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin. Despite multiple therapeutic approaches for the attempted treatment of cellulite, there are no FDA-approved pharmacological treatments.iv
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including, but not limited to, the statements by Drs. Davis and Fabi, and other statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential and product availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the Securities and Exchange Commission (SEC) and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval (SEDAR), including under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings, and as otherwise enumerated herein or therein, could affect Endo's future results and could cause Endo's actual results to differ materially from those expressed in forward-looking statements contained in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.
* Randomized EvaLuation of CEllulite Reduction by CollAgenaSE Clostridium Histolyticum (RELEASE)
i Avram M. Cellulite: a review of its physiology and treatment, Journal of Cosmetic Laser Therapy 2004; 6: 181–185.
ii Khan MH et al. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol. 2010 Mar;62(3):361-70.
iii Querleux B et al. Anatomy and physiology of subcutaneous adipose tissue by in vivo MRI and spectroscopy: Relationship with sex and presence of cellulite, Skin Research and Technology; 8: 118-124.
ivZerini I et al. Cellulite treatment: a comprehensive literature review. J Cosmet Dermatol. 2015 Sep 14(3):224-40
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