Austin Life Sciences Company Completes IL-1α Phase II Clinical Trial and Announces Positive Preliminary Results in Patients with Moderate to Severe Disease
AUSTIN, TX, USA I October 17, 2012 I XBiotech, a privately held biotechnology company, announced positive preliminary results today from their Phase II study using a True Human™ monoclonal antibody (MABp1) in patients with moderate to severe psoriasis. Data from the trial indicate a relatively rapid response in skin lesion severity following an initial subcutaneous injection, and continued improvement over 70 days with a maximum of three injections. Preliminary results demonstrated a 30 percent improvement in Psoriasis Area and Severity Index (PASI) scores within three weeks of receiving the initial subcutaneous dose. Full data from the study will be submitted to a peer-reviewed journal for future publication.
Psoriasis is a relatively common skin disease, affecting 2% of the Western population and about 123,000,000 persons worldwide. It is characterized by chronic inflammatory skin lesions, but patients may also suffer from arthritis or even life-threatening, systemic inflammation. Current treatments consist of topical emollients and steroids, as well as systemic therapies including immunosuppressive regimens and targeted biologics. The inciting lesion behind the pathogenesis of this disease is unknown, however it has increasingly become apparent that psoriasis is a complex, immune-mediated disease.
"What I was most impressed by was the immediate decrease in redness in skin lesions," said Kyle M. Coleman, M.D., American Academy of Dermatology (ADA), and American Society for Dermatologic Surgery (ASDS) member and a lead clinical investigator in the Phase II study from Westlake Dermatology, Austin, Texas. "Inflammation is a driving force in psoriasis, but other therapies aren’t directed at addressing the underlying cause first. Most address skin thickness initially, with resolution in inflammation and redness occurring as a last result. This is a whole new approach that appears to provide a well tolerated therapy with significant patient benefit."
"IL-1α is a master regulator of chronic inflammation that plays a pivotal role in triggering and sustaining the inflammatory process in a variety of disease indications," said John Simard, president and CEO, XBiotech. "Based on data being generated in our clinical trials, we believe that targeting IL-1α holds significant promise as a unique therapeutic option for psoriasis and a variety of other diseases. We are pleased to continue to advance a new medial paradigm for treatments that block chronic inflammation, and to develop therapies that represent a breakthrough in safety and efficacy for patients."
About True Human™ Antibodies
True Human™ antibodies represent the next generation of therapeutic antibodies. These antibodies are identified using the Company’s proprietary platform technology to ensure faithful reproduction of the original human antibody gene. True Human antibodies are "invisible" to the body’s immune system and thus have the potential for better safety, efficacy and patient tolerability compared to earlier generation antibody therapeutics.
About XBiotech
XBiotech is pioneering breakthrough therapies that improve the safety and efficacy of antibody therapeutics. The Company’s lead product candidate inhibits chronic sterile inflammation by targeting IL-1α, a master regulator of inflammation. The clinical development program addresses tremendous unmet medical need in multiple disease indications including, acne, psoriasis, cachexia, cancer, type 2 diabetes and cardiovascular disease. XBiotech is also revolutionizing scalable, flexible manufacturing systems for the production of biological therapies. Using minimal infrastructure and disposable bioreactor technology – to dramatically reduce capital requirements, operating complexity, and lead times – the Company has established a compelling commercialization path for its True Human™ antibody platform. For more information on how XBiotech is advancing human monoclonal antibody therapy please visit www.xbiotech.com.
SOURCE: XBiotech
Post Views: 62
Austin Life Sciences Company Completes IL-1α Phase II Clinical Trial and Announces Positive Preliminary Results in Patients with Moderate to Severe Disease
AUSTIN, TX, USA I October 17, 2012 I XBiotech, a privately held biotechnology company, announced positive preliminary results today from their Phase II study using a True Human™ monoclonal antibody (MABp1) in patients with moderate to severe psoriasis. Data from the trial indicate a relatively rapid response in skin lesion severity following an initial subcutaneous injection, and continued improvement over 70 days with a maximum of three injections. Preliminary results demonstrated a 30 percent improvement in Psoriasis Area and Severity Index (PASI) scores within three weeks of receiving the initial subcutaneous dose. Full data from the study will be submitted to a peer-reviewed journal for future publication.
Psoriasis is a relatively common skin disease, affecting 2% of the Western population and about 123,000,000 persons worldwide. It is characterized by chronic inflammatory skin lesions, but patients may also suffer from arthritis or even life-threatening, systemic inflammation. Current treatments consist of topical emollients and steroids, as well as systemic therapies including immunosuppressive regimens and targeted biologics. The inciting lesion behind the pathogenesis of this disease is unknown, however it has increasingly become apparent that psoriasis is a complex, immune-mediated disease.
"What I was most impressed by was the immediate decrease in redness in skin lesions," said Kyle M. Coleman, M.D., American Academy of Dermatology (ADA), and American Society for Dermatologic Surgery (ASDS) member and a lead clinical investigator in the Phase II study from Westlake Dermatology, Austin, Texas. "Inflammation is a driving force in psoriasis, but other therapies aren’t directed at addressing the underlying cause first. Most address skin thickness initially, with resolution in inflammation and redness occurring as a last result. This is a whole new approach that appears to provide a well tolerated therapy with significant patient benefit."
"IL-1α is a master regulator of chronic inflammation that plays a pivotal role in triggering and sustaining the inflammatory process in a variety of disease indications," said John Simard, president and CEO, XBiotech. "Based on data being generated in our clinical trials, we believe that targeting IL-1α holds significant promise as a unique therapeutic option for psoriasis and a variety of other diseases. We are pleased to continue to advance a new medial paradigm for treatments that block chronic inflammation, and to develop therapies that represent a breakthrough in safety and efficacy for patients."
About True Human™ Antibodies
True Human™ antibodies represent the next generation of therapeutic antibodies. These antibodies are identified using the Company’s proprietary platform technology to ensure faithful reproduction of the original human antibody gene. True Human antibodies are "invisible" to the body’s immune system and thus have the potential for better safety, efficacy and patient tolerability compared to earlier generation antibody therapeutics.
About XBiotech
XBiotech is pioneering breakthrough therapies that improve the safety and efficacy of antibody therapeutics. The Company’s lead product candidate inhibits chronic sterile inflammation by targeting IL-1α, a master regulator of inflammation. The clinical development program addresses tremendous unmet medical need in multiple disease indications including, acne, psoriasis, cachexia, cancer, type 2 diabetes and cardiovascular disease. XBiotech is also revolutionizing scalable, flexible manufacturing systems for the production of biological therapies. Using minimal infrastructure and disposable bioreactor technology – to dramatically reduce capital requirements, operating complexity, and lead times – the Company has established a compelling commercialization path for its True Human™ antibody platform. For more information on how XBiotech is advancing human monoclonal antibody therapy please visit www.xbiotech.com.
SOURCE: XBiotech
Post Views: 62
