Endo International plc – Ordinary Shares (NASDAQ:ENDP) announced today positive results from its Phase 2b study of collagenase clostridium histolyticum (or “CCH”) for the treatment of edematous fibrosclerotic panniculopathy (“EFP”), commonly known as cellulite. CCH is known in its currently approved indications in the U.S. as XIAFLEX® for adult Dupuytren’s contracture and Peyronie’s disease. Trial subjects receiving CCH showed statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial’s primary endpoint (p<0.001), compared to those subjects receiving placebo. CCH was well-tolerated in the actively treated subjects with most adverse events (AEs) being mild to moderate in severity, and primarily limited to the local injection area.
“We continue to be encouraged and very excited by the promising results of our CCH program, especially in the cellulite indication – a condition which affects many millions of people,” said Dr. Susan Hall, Executive Vice President, Chief Scientific Officer and Global Head of R&D at Endo. “We believe these data further reinforce our belief that CCH could be a potential treatment option for those with cellulite and we look forward to working with FDA to efficiently and effectively advance our development of the program into Phase 3.”
The Phase 2b trial enrolled 375 women with moderate or severe cellulite aged 18 years or older in the United States. Each subject received up to three treatment sessions of CCH (0.84 mg / session) or placebo with each treatment session occurring approximately 21 days apart. Twelve injections were administered into cellulite dimples during each session across an entire treatment quadrant – left or right buttock or left or right posteriolateral thigh. At both the outset and conclusion of the study period (28 days after the last treatment), cellulite severity was assessed by each patient and clinician using two photonumeric cellulite severity scales developed by Endo and third-party experts. The scales – the Photonumeric Cellulite Severity Scale (PCSS) – are 5-point scales ranging from 0 (no cellulite) to 4 (severe cellulite) that measure improvement in the appearance of cellulite.
The Phase 2b trial’s primary endpoint was the proportion of composite responders at Day 71 defined as subjects with a 2-point improvement in severity from baseline in the clinician-reported (CR) PCSS and a 2-point improvement in the patient-reported (PR) PCSS. Additional endpoints include a composite of 1-point responders, the percentage of responders with 1-point and 2-point improvements on the CR-PCSS and PR-PCSS, assessment of improvement by patient and clinician using the Global Aesthetic Improvement Scale (GAIS); subject satisfaction, and change in the Hexsel cellulite severity scale.
“I believe these positive results demonstrate that CCH has the potential to be a treatment option for cellulite, a condition for which there are very limited safe and proven effective treatments,” said Mitchel P. Goldman, MD, Medical Director, Cosmetic Laser Dermatology. “With so many millions of women affected by cellulite, there is a substantial need for new and innovative therapeutic options.”
Key Phase 2b Trial Results Include:
- Subjects receiving CCH demonstrated a highly statistically significant improvement in the primary endpoint of composite investigators’ and patients’ assessments of the appearance of cellulite, as measured by a two-point improvement in both the CR-PCSS and PR-PCSS scores, with a p-value of <0.001 versus placebo
- Subjects receiving CCH demonstrated a highly statistically significant improvement in the composite investigators’ and patients’ assessments of the appearance of cellulite, as measured by a one-point improvement in both the CR-PCSS and PR-PCSS scores, with a p-value of <0.001 versus placebo
- A highly significant proportion of CCH subjects reported being “Satisfied” or “Very Satisfied” with their cellulite treatment, compared to placebo subjects, with a p-value of <0.001
- A highly significant proportion of CCH subjects were reported as “Improved” or “Very Improved” or “Very Much Improved” in global appearance of their cellulite area as assessed by the subjects and investigators, compared to placebo subjects, with a p-value of <0.001
- 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; 92 percent of all related AEs were mild to moderate in the CCH group compared to 96 percent in the placebo group; the most common AEs were expected and included injection site bruising (approximately 75 percent) and injection site pain (approximately 59 percent)
“These data are exciting for the medical community and definitely warrant further investigation and development,” said Neil Sadick, MD, Clinical Professor of Dermatology, Weill Cornell Medical College. “By successfully advancing this program, we could offer patients currently seeking cellulite treatment a new and promising option.”
Results for an earlier Phase 2a trial of CCH for the treatment of cellulite demonstrated that three doses of CCH (low (0.06mg), mid (0.48mg) and high (0.84mg)) showed 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. The mid and high dose groups demonstrated a statistically significant improvement in the appearance of cellulite, as measured by GAIS scores, with a p-value of <0.05 compared to placebo for both endpoints. In the mid and high dose groups, 68 percent of patients reported being “Satisfied” or “Very Satisfied” with the results of their treatment, compared to only 34 percent of patients randomized to placebo. 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. (Original Source)
Shares of Endo are currently trading at $17.24, up $0.14 or 0.82%. ENDP has a 1-year high of $63.71 and a 1-year low of $12.56. The stock’s 50-day moving average is $20.42 and its 200-day moving average is $18.86.
On the ratings front, Endo has been the subject of a number of recent research reports. In a report issued on November 11, Mizuho analyst Irina Rivkind Koffler reiterated a Buy rating on ENDP, with a price target of $25, which represents a potential upside of 46% from where the stock is currently trading. Separately, on November 10, BMO’s Gary Nachman reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Irina Rivkind Koffler and Gary Nachman have a yearly average return of 17.9% and 12.3% respectively. Koffler has a success rate of 51% and is ranked #60 out of 4226 analysts, while Nachman has a success rate of 72% and is ranked #404.
Sentiment on the street is mostly neutral on ENDP stock. Out of 9 analysts who cover the stock, 5 suggest a Hold rating and 4 recommend to Buy the stock. The 12-month average price target assigned to the stock is $28.67, which represents a potential upside of 68% from where the stock is currently trading.
Endo International Plc operates as a pharmaceutical company. It focuses on developing, manufacturing, and distributing of branded and generic pharmaceutical products. It operates through the following segments U.S. Branded Pharmaceuticals, U.S. Generic pharmaceuticals, Devices, and International Pharmaceuticals. The U.S. Branded Pharmaceuticals offers products that focus on the treatment and management of conditions in urology, urologic oncology, endocrinology, and orthopedics. The U.S. Generic pharmaceuticals segment consist of a differentiated product portfolio including high-barrier-to-entry products, first-to-file or first-to-market opportunities that are difficult to formulate, difficult to manufacture or face complex legal and regulatory challenges. The Devices segment offers medical devices that deliver innovative medical technology solutions to physicians treating female incontinence and pelvic floor repair. The International Pharmaceuticals segment includes a variety of pharmaceutical products for the Canadian, Latin American, South African, and world markets.