Cassiopea SpA’s Clascoterone cream 1% is safe for the treatment of acne with low rates of treatment-related adverse events, according to a study in the online issue of Journal of the American Academy of Dermatology (JAAD).
Clascoterone is a topical androgen receptor inhibitor that fights acne by limiting dihydrotestosterone binding to the androgen receptors in the sebaceous gland. The US Food and Drug Administration is reviewing a New Drug Application for Clascoterone cream 1% with an expected PDUFA date of August 27, 2020.
"These results underscore the promise of Clascoterone cream 1% as a first in class topical acne treatment with a favorable safety profile that targets the androgen receptor in both males and females 9 years of age and older," says Dr. Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, in a news release. “Safety data published in JAAD showed that Clascoterone has a consistent and favorable safety profile."
The multi-center, open-label, long-term extension study, CB-03-01/27, enrolled a total of 609 subjects from the pivotal studies /25 and /26, with 347 completing the study (n = 179 Clascoterone cream, n = 168 vehicle cream, original group assignment). Eligible patients for CB-03-01/27 must have completed one of the 12-week Phase III pivotal studies.
The two Phase III vehicle-controlled studies (CB-03-01/25 and CB-03-01/26) published in JAMA Dermatology showed Clascoterone cream significantly improved Investigator's Global Assessment (IGA) scores and lesion counts in subjects greater than 9 years of age with moderate to severe acne.
Clascoterone and vehicle-treated subjects from these pivotal Phase III trials participated in this study, CB-03-01/27; the extent of drug exposure and adverse events were assessed, evaluating long-term safety of Clascoterone cream.
All subjects applied Clascoterone cream 1% twice daily to the face for up to twelve months and/or trunk for up to nine months. Patient visits occurred at months 1, 3, 6, and 9 where disease severity (IGA score), medication use, vital signs, AEs, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) were assessed in all patients. Subjects were assessed on the IGA 5-point scale from clear to severe; if subject was more than mild at an evaluation visit, the treatment regimen continued.
Key safety findings showed that Clascoterone cream 1% had a low frequency of TEAE's over long-term observed treatment. Local skin reactions were mostly mild. Long-term efficacy was not a primary endpoint of this study.