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 first half of 2018, 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. Click here for phase 2 data on Vered
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. During 2017, we have completed a double-blind, dose-ranging placebo-controlled, six-arm, multicenter Phase II trial in the U.S. Click here for TWIN phase II results.
Subject to an End of Phase II meeting to be scheduled with the FDA in the second quarter of 2018, we plan to initiate two pivotal Phase III trials for TWIN in the United States in the second half of 2018 and expect to report top-line data from these trials in 2019.
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 have been 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.
Subject to an End of Phase II meeting to be scheduled with the FDA with regard to the Phase II TWIN trial, we plan to commence a pivotal Phase III program for SIRS-T in the United States in 2020 and expect to report top-line data from this program in 2021.
In addition to drug products based on our proprietary delivery system, our pipeline includes six generic drug candidates in our pipeline; some are being developed before the reference listed drug (RLD) is approved; one received tentative approval.
Our Paragraph IV ANDA for ivermectin cream, 1%, received tentative approval from the FDA.
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.
Four of our generic drug product candidates are being developed in collaboration with Perrigo and one with Douglas Pharmaceuticals.
We plan to initiate a bioequivalence study regarding another generic drug candidate in H2/2018.