Knocking the spots off acne
Connetics Corporation, a specialty pharmaceutical company focused on dermatology, has received a positive outcome from its Phase III clinical trials evaluating Velac in the topical treatment of acne vulgaris.
Connetics Corporation, a specialty pharmaceutical company focused on dermatology, has received a positive outcome from its Phase III clinical trials evaluating Velac in the topical treatment of acne vulgaris.
Velac is a first-in-class, once-a-day treatment combination of 1% clindamycin and 0.025% tretinoin in an aqueous gel.
The two Velac Phase III trials comprise the largest-ever pivotal program conducted by Connetics and included more than 2,200 patients with mild-to-moderate acne at 37 centres, in which patients were treated for 12 weeks in double-blinded, placebo- and active-controlled studies. The Phase III trials were of identical design evaluating the beneficial effect of Velac compared with each of the single active ingredients, clindamycin gel and tretinoin gel, and with the placebo gel on two primary efficacy endpoints: Lesion Count and Investigator's Static Global Assessment (ISGA). The Lesion Count endpoint is measured as a percent reduction in two out of three lesion counts (inflammatory, non-inflammatory and total). Treatment success based on ISGA is measured as the proportion of patients who are clear or almost clear of lesions at the end of treatment.
The data from each trial demonstrated a consistently robust and statistically superior treatment effect for Velac compared with clindamycin gel, tretinoin gel and placebo gel on both of the primary endpoints. An analysis of the combined data from the two clinical trials demonstrated similar results to the individual trials. In the combined analysis, the proportion of patients achieving treatment success on the ISGA were: 37% Velac, 27% clindamycin gel, 25% tretinoin gel and 14% vehicle gel (p<0.0001 for all comparisons). The mean percent reduction in total lesion counts was: 49% Velac, 38% clindamycin gel, 40% tretinoin gel and 23% vehicle gel (p<0.0001 for all comparisons).
The data from these trials also demonstrated that Velac was safe and well tolerated, with the most commonly observed adverse effects being application site reactions (e.g. burning, dryness, redness and peeling).
'We are delighted with the strength of the Velac pivotal data, and look forward to the prospect of bringing this significant advancement in the treatment of acne to dermatologists and their patients. As Velac is a patent-protected, first-in-class combination product, we expect it to play an important role as we build a strong franchise in the $1bn US acne market. Acne is one of the largest segments in dermatology, and Velac, if approved, targets three of the four causes of acne and represents the largest sales potential of any product in our pipeline,' said Thomas Wiggans, president and ceo of Connetics.
Velac increases the opportunity for Connetics in the acne market and complements Actiza, an investigational new drug formulation of 1% clindamycin delivered in the Company's proprietary VersaFoam delivery system. The FDA accepted the Actiza NDA for filing in December 2003.
About Velac
Velac is a once daily topical treatment that combines clindamycin, the No.1 prescribed topical antibiotic for acne, and tretinoin, the No.1 prescribed topical retinoid for acne. The combination drug has a triple-action effect combining the anti-inflammatory and antimicrobial effects of clindamycin with the beneficial comedolytic effects of tretinoin in normalizing the plugging of pores, which leads to acne lesions. Velac is delivered in an elegant, non-alcoholic gel. In May 2002, Connetics licensed rights from Yamanouchi Europe to develop and commercialise Velac exclusively in the US and Canada, and non-exclusively in Mexico. Velac is approved in Europe.