Endo Will Showcase Late-Breaking Phase 3 CCH Data at the 2019 American Academy of Dermatology Annual Meeting
Endo To Present Data From Two Abstracts on Collagenase Clostridium Histolyticum
The RELEASE-1 and RELEASE-2 Phase 3 studies, which were identically designed, randomized, double blinded and placebo-controlled, assessed the efficacy, safety and tolerability of CCH for the treatment of cellulite in women. A greater percentage of the 843 women treated during the studies (CCH vs. placebo: RELEASE 1, n=210 vs n=213; RELEASE-2, n=214 vs n=206) met the primary endpoint of response with CCH versus placebo in both the RELEASE-1 (P=0.006) and RELEASE-2 (P=0.002) studies.
"Our Phase 3 clinical trial program exhibited promising results and we are pleased to present the late-breaking data at the AAD Annual Meeting, a trusted, dependable source of dermatologic education," said
In addition, statistically significant improvements with CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints. Other patient-centric endpoints were also evaluated, including improvement in the Subject Global Aesthetic Improvement Scale (S-GAIS), a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the subject. Most adverse events observed in CCH-treated patients were mild/moderate and injection-site related (e.g., bruising, pain, nodule, pruritus, erythema, and discoloration).
"I see patients on a regular basis who are embarrassed and uncomfortable about their cellulite, yet there are currently limited effective treatment options available," said
Additionally, an encore e-poster presentation of the Human Pharmacokinetics of Subcutaneous CCH and Preclinical Safety of
About RELEASE-1 and RELEASE-2
RELEASE-1 and RELEASE-2 are two identical, multicenter, randomized, double-blind, placebo-controlled studies that enrolled 845 women aged 18 years or older in
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.1,2 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.2,3 . Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.
It is known that cellulite is different from generalized obesity. In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.4 In areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere. Weight gain may make cellulite more noticeable, but it may be present even in thin subjects.
Despite multiple therapeutic approaches for the attempted treatment of patients with cellulite, there are currently 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 statement by Drs. Davis and Kaufman-Janette, 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
- Avram M. Cellulite: a review of its physiology and treatment,
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- Khan MH et al. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol. 2010 Mar;62(3):361-70.
- 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 Researchand Technology; 8: 118-124.
- Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol 2010;62(3):361-370.
- Zerini I et al. Cellulite treatment: a comprehensive literature review. J Cosmet Dermatol. 2015 Sep 14(3):224-40
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Media: Heather Zoumas-Lubeski, (484) 216-6829; Investors: Pravesh Khandelwal, (845) 364-4833