NEW YORK, July 16, 2015 /PRNewswire/ --
ACI Association has initiated research coverage on Anacor Pharmaceuticals, Inc. (NASDAQ : ANAC ). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.
Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=ANAC
Highlights from our ANAC Report include:
- Preliminary outcome of Clinical studies - On July 13, 2015, the biopharmaceutical company, Anacor Pharmaceuticals, Inc. announced positive preliminary top-line results from its two phase 3 pivotal studies of Crisaborole Topical Ointment, 2% (formerly AN2728), conducted in patients with mild-to-moderate atopic dermatitis. During both the trials, Crisaborole Topical Ointment, which is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor, achieved statistically significant results on all primary and secondary endpoints while demonstrating a safety profile consistent with previous studies.
- Details of Phase 3 Pivotal Studies - As stated by the Company, the Phase 3 pivotal studies of crisaborole consisted of two multi-center, double-blind, vehicle-controlled studies of over 750 patients each, aged 2 years and older with mild-to-moderate atopic dermatitis, which refers to a chronic rash characterized by inflammation and itching. (defined as an ISGA score of 2 (mild) or 3 (moderate)). The ISGA is a 5-point scale ranging from 0 (clear) to 4 (severe). Crisaborole was applied on the patients twice daily for 28 days. The primary endpoint of the studies was success in ISGA at day 29 (defined as the proportion of patients achieving an ISGA a score of 0 (clear) or 1 (almost clear) with a minimum 2-grade improvement from base-line).
- Safety evaluation of the two studies - Anacor Pharmaceuticals stated that the safety evaluation results, which included reported adverse events, safety laboratory tests and vital signs, was in line with the previous studies. In terms of severity, majority of adverse events were graded as mild in patients treated with Crisaborole. Apart from the Phase 3 pivotal studies, the Company is also conducting an open-label long-term safety study to evaluate the intermittent use of crisaborole for up to 12 months, the result of which is expected to be announced by 2015 end.
- Plan to file New Drug Application - The Company plans to file a New Drug Application (NDA) for crisaborole in the first half of 2016. According to the Company, approximately 18 to 25 million people in the United States suffer from atopic dermatitis, and 80% to 90% have mild or moderate disease. These patients suffering from the disease often try multiple treatments, yet many are not satisfied with the effectiveness of their medications. If the NDA gets approved by the US Food and Drug Administration (USFDA), Crisaborole could offer an important treatment option for patients with mild-to-moderate atopic dermatitis.
To find out how this influences our rating on Anacor Pharmaceuticals, Inc., read the full report in its entirety here: http://www.aciassociation.com/?c=ANAC
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