Phase 3 Data Published in the Journal of the American Academy of Dermatology
NEW YORK, NY, USA I July 13, 2016 I Pfizer Inc. (NYSE:PFE) announced today the publication of findings from two pivotal Phase 3 studies of investigational crisaborole topical ointment 2% (formerly AN2728) in the online issue of the Journal of the American Academy of Dermatology.
“Atopic dermatitis, or eczema, is a chronic, inflammatory skin disease that affects millions of children and adults. There have been no new therapies approved in the United States for people with atopic dermatitis in the past 15 years,” said Amy Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine. “The results seen in these pivotal Phase 3 studies demonstrate that crisaborole, if approved, could be a meaningful treatment option for patients with mild to moderate atopic dermatitis.”
The detailed results from the Pivotal Phase 3 studies (AD-301 and AD-302) showed that crisaborole achieved statistically significant results on primary and secondary endpoints for the treatment of atopic dermatitis (AD) in children two years of age and up and adults versus vehicle ointment alone. Crisaborole treatment-related adverse events were infrequent, mild to moderate in severity, and similar to vehicle ointment.
“The addition of crisaborole to the Pfizer inflammation and immunology portfolio as a potential treatment option for patients with mild to moderate atopic dermatitis underscores our commitment to deliver innovative medicines for patients with high unmet needs in medical dermatology,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, “This publication highlights the quality of the Phase 3 clinical data with crisaborole, and we are excited to continue to work with our Anacor colleagues and regulatory authorities in our effort to bring this important medicine to patients.” Pfizer recently completed the acquisition of Anacor Pharmaceuticals. If approved, crisaborole would represent the first commercialized product as a result of the combination with Anacor.
About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic condition characterized by inflammation and itching.1,2,3 Lesions of AD are commonly red, elevated patches and are often accompanied by pruritus (itching).1,2,3 Based on available sources, approximately 18 to 25 million people in the United States suffer from AD,4 and 80% to 90% have mild or moderate disease.5 AD most commonly appears in childhood, with estimates that between 8% and 18% of all infants and children in the United States are affected by the disease.6
About Crisaborole Topical Ointment, 2%
Crisaborole topical ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE4 inhibitor in development for the potential treatment of mild to moderate AD. Crisaborole is a boron-containing small molecule that inhibits PDE4 in target cells, which may reduce the production of pro-inflammatory cytokines thought to cause the signs and symptoms of AD.
SOURCE: Pfizer
Post Views: 138
Phase 3 Data Published in the Journal of the American Academy of Dermatology
NEW YORK, NY, USA I July 13, 2016 I Pfizer Inc. (NYSE:PFE) announced today the publication of findings from two pivotal Phase 3 studies of investigational crisaborole topical ointment 2% (formerly AN2728) in the online issue of the Journal of the American Academy of Dermatology.
“Atopic dermatitis, or eczema, is a chronic, inflammatory skin disease that affects millions of children and adults. There have been no new therapies approved in the United States for people with atopic dermatitis in the past 15 years,” said Amy Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine. “The results seen in these pivotal Phase 3 studies demonstrate that crisaborole, if approved, could be a meaningful treatment option for patients with mild to moderate atopic dermatitis.”
The detailed results from the Pivotal Phase 3 studies (AD-301 and AD-302) showed that crisaborole achieved statistically significant results on primary and secondary endpoints for the treatment of atopic dermatitis (AD) in children two years of age and up and adults versus vehicle ointment alone. Crisaborole treatment-related adverse events were infrequent, mild to moderate in severity, and similar to vehicle ointment.
“The addition of crisaborole to the Pfizer inflammation and immunology portfolio as a potential treatment option for patients with mild to moderate atopic dermatitis underscores our commitment to deliver innovative medicines for patients with high unmet needs in medical dermatology,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, “This publication highlights the quality of the Phase 3 clinical data with crisaborole, and we are excited to continue to work with our Anacor colleagues and regulatory authorities in our effort to bring this important medicine to patients.” Pfizer recently completed the acquisition of Anacor Pharmaceuticals. If approved, crisaborole would represent the first commercialized product as a result of the combination with Anacor.
About Atopic Dermatitis
Atopic dermatitis (AD) is a chronic condition characterized by inflammation and itching.1,2,3 Lesions of AD are commonly red, elevated patches and are often accompanied by pruritus (itching).1,2,3 Based on available sources, approximately 18 to 25 million people in the United States suffer from AD,4 and 80% to 90% have mild or moderate disease.5 AD most commonly appears in childhood, with estimates that between 8% and 18% of all infants and children in the United States are affected by the disease.6
About Crisaborole Topical Ointment, 2%
Crisaborole topical ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE4 inhibitor in development for the potential treatment of mild to moderate AD. Crisaborole is a boron-containing small molecule that inhibits PDE4 in target cells, which may reduce the production of pro-inflammatory cytokines thought to cause the signs and symptoms of AD.
SOURCE: Pfizer
Post Views: 138
