Endo Announces Initiation Of Two Pivotal Phase 3 Clinical Trials Of Collagenase Clostridium Histolyticum For The Treatment Of Cellulite
"Despite the number of options currently marketed as cellulite remedies, there still are no
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 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
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.
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
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 (
* Randomized EvaLuation of CEllulite Reduction by CollAgenaSE Clostridium Histolyticum (RELEASE)
i Avram M. Cellulite: a review of its physiology and treatment,
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,
ivZerini I et al. Cellulite treatment: a comprehensive literature review. J Cosmet Dermatol. 2015 Sep 14(3):224-40
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Endo International plc: Investors/Media: Stephen Mock (845) 364-4833; Investors: Nina Goworek, (484) 216-6657; Media: Heather Zoumas-Lubeski, (484) 216-6829