Endo International has started its Phase 2b study of collagenase clostridium histolyticum (CCH) for the treatment of edematous fibrosclerotic panniculopathy, commonly known as cellulite.
Cellulite is a localised metabolic disorder affecting tissue under the skin, and has been reported in 85 to 98% of post-pubertal women.
The condition can involve the loss of elasticity or shrinking of collagen cords, called septae, which attach the skin to the muscle layers below.
In its currently approved indications in the US, CCH is known as Xiaflex.
Endo International executive vice president, chief scientific officer and global head of R&D and quality Dr. Susan Hall said: "Cellulite affects millions of US women, dimpling their skin, impacting their appearance and causing bother and self-consciousness for many."
"There are no FDA-approved pharmacological options for cellulite and many currently available treatment options have not demonstrated a scientific benefit.
"We believe that if CCH is successful in clinical trials and if approved by the FDA, it could become the first office-based biological treatment option for cellulite that is supported by scientific results.
"Endo is looking forward to expanding the understanding of using CCH for this aesthetic indication."
In the Phase 2b trial, 350 women aged 18 or older are being enroled in the US.
Each individual will undergo up to three treatment sessions with 0.84mg CCH or a placebo, with each session occurring around 21 days apart.
During each session, 12 injections will be administered into cellulite dimples across a complete treatment quadrant, from the left or right buttock to the left or right posterior thigh.
At the beginning and conclusion of treatment, cellulite severity will be reviewed using two photonumeric scales developed by Endo, third-party experts, and the US Food and Drug Administration (FDA).
The scale ranges from 0, which indicates no cellulite, to 4, which indicates severe cellulite.
Besides the patient and physician assessments, an independent five-member panel of trained aesthetic clinicians will review pre-treatment and end-of-study photo images of patients using the PCSS.
Results of an earlier Phase 2 trial of CCH for the treatment of cellulite demonstrated that three doses of CCH (low (0.06mg), mid (0.48mg) and high (0.84mg) indicated an improvement in the appearance of cellulite, as measured by the trial endpoints of an investigator and a patient score on the GAIS, which was adapted for use in cellulite.
In December 2015, Endo International had announced the extension of its exclusive US marketing rights for the marketed prescription medicine Voltaren Gel (diclofenac sodium topical gel) 1% as well as for the product’s Authorised Generic, if Endo were to opt to commercially launch it in the future.
Endo, through an indirect completely owned subsidiary, has entered into a licensing agreement with Sandoz and Novartis until 30 June 2023.