Phase 3 Data of Collagenase Clostridium Histolyticum for the Investigational Treatment of Cellulite to Be Presented at The Aesthetic Meeting 2019
Clinical Investigator Dr.
"Last year at Hot Topics, my colleagues expressed great interest in the data that I presented on CCH for cellulite," said Dr. Bass. "An injectable option to treat cellulite, if approved, would be very meaningful to our patients, which is why I am thrilled to be back this year to share the positive results from the Phase 3 studies."
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.
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).
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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 makes cellulite more noticeable, but it may be present even in thin subjects. Genetics may also play a role, since cellulite tends to run in families.
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 Bass, 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
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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,
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- 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