VERED is an innovative topical encapsulated benzoyl peroxide cream with a 5% concentration for the treatment of papulopustular rosacea.
Benzoyl peroxide is known to be an effective treatment for rosacea, but causes significant irritation. Our silica-based microencapsulation delivery system creates a silica barrier between benzoyl peroxide crystals and the skin, and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide, thereby making the drug tolerable to rosacea-affected skin. Our solution also alters the release profile of the drug substance to reduce skin irritation while maintaining efficacy. In a double-blind, randomized, dose-ranging Phase II clinical trial for VERED, involving 92 adult patients at ten centers in the U.S., VERED demonstrated statistically significant efficacy versus the control vehicle.
Moreover, the safety and tolerability profile of VERED was similar to that of the vehicle. In the second half of 2017, we expect to commence two double-blind, placebo controlled, multi-center pivotal Phase III clinical trials for VERED in the U.S, with results within one year after commencement.
TWIN is a novel non-antibiotic topical cream for the treatment of acne vulgaris (acne) that we designed to be tolerable and highly effective.
TWIN is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using our proprietary technology. Tretinoin and benzoyl peroxide are widely believed to be highly effective as a combination treatment for acne.
However, benzoyl peroxide causes degradation of the tretinoin molecules, thereby reducing its effectiveness. By separately encapsulating the tretinoin and the benzoyl peroxide, we have addressed this industry-wide challenge: The silica microcapsule protects tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability and clinical and commercial shelf-life. The silica shell also creates a barrier between the drug substances and the skin and as a result is expected to reduce irritation typically associated with topical application of benzoyl peroxide and tretinoin, thereby increasing the tolerability of TWIN on acne-affected skin. Pre-clinical data demonstrates that TWIN exhibits increased tolerability relative to non-encapsulated tretinoin and when compared to Epiduo, without any corresponding loss in efficacy. We believe that TWIN is more effective than Epiduo because it contains tretinoin as opposed to adapalene, and tretinoin is known to be more effective than adapalene as a standalone acne treatment, but generally causes greater skin irritation. In March 2016, we initiated a double-blind, dose-ranging placebo-controlled, six-arm, multicenter Phase II trial in the U.S.
Upon the successful completion of the Phase II trial, which is expected in the first half of 2017, we plan to initiate a pivotal double-blind, placebo-controlled, two-arm, multicenter trial in the U.S.
SIRS-T, a topical encapsulated tretinoin cream, is being developed for dermatologists and patients that have a preference for using an efficacious and more tolerable tretinoin. SIRS-T's efficacy and safety are currently being evaluated in TWIN phase II trial. The silica shell creates a barrier between the drug substances and the skin and as a result is expected to reduce irritation typically associated with topical application of tretinoin, making SIRS-T more tolerable to acne-affected skin. The release profile of tretinoin was tuned to reduce irritation while maintaining efficacy. We believe that a more tolerable tretinoin drug product will improve patients’ compliance.
In a cumulative 14-day non-occlusive skin irritation trial with 14-day recovery in five Göttingen minipigs, we compared SIRS-T to generic tretinoin gel 0.1%. Erythema and edema were scored as very slight, well-defined, moderate or severe, and were monitored over the 28 day period. SIRS-T 0.1% was found to be non-irritant, similar to the untreated group, while generic tretinoin gel 0.1% was shown to be irritating.
E-06 is a cream formulation of a new fixed-dose combination, containing an antifungal agent and a mid-potency steroid for the treatment of symptomatic interdigital tinea pedis (athlete's foot).
E-06 is expected to rapidly relieve inflammatory signs and symptoms such as erythema, itching and burning, thereby improving patient comfort and compliance.
In September 2016, we initiated a Phase II trial to evaluate the safety and efficacy of E-06 in the U.S.
In addition to drug products based on our proprietary delivery system, our pipeline includes two generic dermatological candidates in different stages of development.
Our goal is to be the first-to-file in all four generic projects.
Product Y is currently being evaluated in a bioequivalence study.
Product Z is in earlier stages of development.
In addition to advancing our lead product candidates, we are also engaged in the formulation and pre-clinical development of early stage innovative product candidates for both current focus indications, such as acne and rosacea and for other dermatological indications.