XBiotech Announces First Patient in Phase 2 Study Evaluating MABp1 in Patients with Atopic Dermatitis
First Patient Begins Therapy with MABp1 for Treatment of Atopic Dermatitis
AUSTIN, Texas, May 22, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient has been enrolled in its Phase 2 open label, dose escalation clinical study evaluating MABp1 in patients with moderate to severe Atopic Dermatitis (AD). The patient began treatment at Florida Academic Dermatology Center under the care of the Study's Chair, Dr. Francisco Kerdel.
Dr. Kerdel commented, "Atopic dermatitis is a chronic inflammatory disease characterized by dry and scaly skin and severe, unrelenting itching. An inflammatory substance released by keratinocytes known as IL-1alpha, is believed to be a key trigger of inflammation in the disease. By neutralizing the activity of IL-1alpha, the new agent we are testing may arrest the disease process and offer relief from the debilitating symptoms. Today we treated a patient and I can report that within one hour of treatment, there was an unequivocal reduction in erythema [redness of the skin] and the patient reported an almost immediate reduction in associated pruritus [itching]. This is an extremely intriguing start for this promising therapy."
John Simard, the Company's President and CEO, added, "Interleukin-1alpha is emerging as a key therapeutic target in inflammatory skin diseases. We are extremely excited about the potential of our antibody to represent a breakthrough treatment for atopic dermatitis."
XBiotech is developing a human-derived antibody which neutralizes IL-1 alpha (IL-1alpha), an inflammatory cytokine that plays a key role in the pathophysiology of a wide range of inflammatory skin disorder1. Three phase II studies sponsored by XBiotech have been completed in dermatologic indications (acne, psoriasis, pyoderma gangrenosum) as well as one investigator sponsored study in Hidradenitis Suppurativa. In these studies, MABp1 was well tolerated and showed good therapeutic responses2,3,4.
About the Study
The phase 2, open label, dose escalation, multicenter study will consist of two dose cohorts of MABp1 in patients with moderate to severe AD. Dose ranging in the present study will include evaluation of the Company's new highly-concentrated subcutaneous formulation. Ten patients will receive a total of 4 weekly 200mg subcutaneous injections of MABp1. Following a safety assessment for patients in the first dose cohort, ten patients will receive 4 weekly 400mg subcutaneous injections of MABp1. Patients will be followed for 6 weeks to allow for assessment of safety and preliminary efficacy. Various efficacy measures will be assessed including changes in Eczema Area and Severity Index Score (EASI), Dermatology Life Quality Index (DLQI), Patient Oriented Eczema Measure (POEM), and SCORing Atopic Dermatitis (SCORAD), a measure of disease severity in AD.
About Atopic Dermatitis
Atopic dermatitis (AD) is an inflammatory skin disease affecting as much as 20% of the population in western industrial societies. Chronic eczema in AD and associated pruritus can be a significant cause of morbidity and impact life quality. Disease pathogenesis is complex but ultimately converges on a pathological inflammatory process that disrupts the protective barrier function of the skin. Keratinocytes are a major reservoir of IL-1alpha and may be a key source of inflammatory stimulus in AD. IL-1alpha is present on leukocytes, where its role in leukocyte trafficking and infiltration may represent a key step in the chronic inflammation of AD. IL-1alpha is a key inducer of matrix metalloproteinases activity which could be directly involved in the epithelial barrier breakdown in AD5. Loss of regulation of IL-1 results in systemic inflammation with extensive skin involvement6.
XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
1 Bou-Dargham MJ et al. The Role of Interleukin-1 in Inflammatory and Malignant Human Skin Diseases and the Rationale for Targeting Interleukin-1 Alpha. Med Res Rev. 2017 Jan;37(1):180-216.
2 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017 Nov 9.
3 Coleman KM et al. Open-Label Trial of MABp1, a True Human Monoclonal Antibody Targeting Interleukin 1alpha, for the Treatment of Psoriasis. JAMA Dermatol. 2015 May;151(5):555-6.
4 Carrasco D et al. An Open Label, Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity. J Drugs Dermatol. 2015 Jun;14(6):560-4.
5 Han et al. Interleukin-1alpha-induced proteolytic activation of metalloproteinase-9 by human skin. Surgery. 2005 Nov;138(5):932-9.
6 Askentijevich et al. An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist. N Engl J Med. 2009 Jun 4;360(23):2426-37.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via Globenewswire
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
BIMobject AB: BIMobject påbörjar processen för notering vid Nasdaq Stockholm19.6.2018 08:25 | Pressmeddelande
BIMobject, idag listat på First North, har beslutat att påbörja processen för att notera bolagets aktier vid Nasdaq Stockholm. Bolagets ambition är att vara noterad inom 16-20 månader. En notering på Nasdaq Stockholm är ett naturligt steg i BIMobjects utveckling och öppnar för ett ökat institutionellt ägande. Bolaget befinner sig i en stark tillväxtfas och en notering på Nasdaq Stockholm stärker kännedomen om BIMobjects verksamhet samt ger en kvalitetsstämpel som ökar tillgången till nationell och internationell kapitalmarknad. "Vi är idag ett av de högst värderade bolagen på First North och det har hela tiden varit vår ambition att använda First North som ett steg mot börsen och en notering vid Nasdaq Stockholm. Vi inleder nu det omfattande arbete som krävs för att anpassa rutiner och arbetsprocesser till en noterad miljö. Genom Nasdaq Stockholm får vi tillgång till en mer likvid och dynamisk marknadsplats som kommer att ge nuvarande och framtida investerare större möjligheter att han
Vricon's disruptive 3D GEOINT technology fuels company growth18.6.2018 22:23 | Pressmeddelande
Company's momentum reflects growing need for high-resolution, extremely accurate 3D data and solutions McLean, VA, June 18, 2018 (GLOBE NEWSWIRE) -- Vricon, a global leader in 3D data and solutions, today announced that it has more than doubled its year-over-year sales growth rate and set a record pace for new customer acquisition. Vricon serves the global professional geospatial market with world-leading 3D geodata and 3D visualization solutions. With direct access to the world's largest global imagery archive, Vricon uses automated 3D image-processing algorithms inside a state-of-the-art high-performance computing environment to produce its high-resolution 3D data and solutions for government and commercial clients. Use of 3D geodata helps users to see the world as it really exists, explain what they're seeing more clearly, and better convey their findings to decision makers. Vricon has greatly increased and diversified its government-sector portfolio. From early 2017 to today, Vrico
Cloudian wins Cloud Company of the Year at the 2018 UK Storage Awards18.6.2018 19:05 | Pressmeddelande
SAN MATEO, Calif. and LONDON, June 18, 2018 (GLOBE NEWSWIRE) -- Cloudian, the innovation leader in enterprise object storage systems, today announced that it has been awarded "Cloud Company of the Year 2018" at the UK Storage Awards. The win, which builds on its win as "Enterprise Hybrid Storage Product of the Year" at the 2017 ceremony, comes as Cloudian achieves record-breaking year-on-year success and growth across EMEA. The Storage Awards mark one of the biggest award nights in the storage industry, recognising IT's most innovative leaders and rewarding those that make significant contributions to the industry. Attended by global companies of all sizes, the ceremony took place at The Tower Hotel in London. Peers, partners and clients took part in a round of voting to select the deserving winners - with a record number of votes cast. This year, Cloudian walked away as "Cloud Company of the Year 2018," awarded for its innovative contributions to the cloud computing world. Throughout
Raven Indusries Releases CR12(TM) Field Computer18.6.2018 16:49 | Pressmeddelande
12-Inch Display With Field Planning Features Helps Farmers Save Time and Increase Efficiencies MIDDENMEER, The Netherlands, June 18, 2018 (GLOBE NEWSWIRE) -- Raven Industries (NASDAQ:RAVN) announced today the release of a new, larger field computer: the CR12(TM). Utilizing the same powerful functionality as the CR7(TM) field computer, the CR12 offers an extensive field planning feature for increased efficiencies. Built with a durable magnesium waterproof housing and a full glass capacitive touchscreen with high brightness, the CR12 also boasts a wider, 12.1-inch display. The CR12 joins the CR7 as the latest field computer in the CRX display family. This powerful operating system features easy job set-up, fewer touches and greater efficiencies - empowering the user with extraordinary data management capabilities. A simple widget concept, easily accessible settings, and ISO Universal Terminal and Task Controller capabilities make this mighty unit an affordable, plug-and-play system. Like
FPGA programming solution goes live at AEE 2018 in latest version of SLX18.6.2018 15:00 | Pressmeddelande
Silexica / FPGA programming solution goes live at AEE 2018 in latest version of SLX . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. Industry-first solution fully explores the design space to optimize hardware/software partitioning SLX automatically inserts pragmas and rewrites code to make it High-Level Synthesis (HLS) ready Solution designed in collaboration with customers including Ricoh SAN JOSE, Calif. and COLOGNE, Germany, June 18, 2018 (GLOBE NEWSWIRE) -- Silexica will launch a new solution within SLX to support the increasing use of FPGAs for embedded computing tasks such as sensor fusion and deep learning. It has been developed in partnership with Ricoh and other customers who will use the solution for industrial automation and defense projects. The technology will be presented at Silexica's first appearance one of the world's biggest avionics exhibitions - AEE held in Munich from June 19-20. The
Immunicum AB (publ) meddelar publicering av en översiktsartikel kring ilixadencel-konceptet i Pharmaceutical Research18.6.2018 14:00 | Pressmeddelande
Pressmeddelande 18 juni 2018 Immunicum AB (publ) meddelar publicering av en översiktsartikel kring ilixadencel-konceptet i Pharmaceutical Research Immunicum AB (publ; IMMU.ST) offentliggjorde i dag online-publiceringen av en översiktsartikel av den senaste tidens utveckling inom immunonkologiforskning, med särskilt fokus på tidigare publicerade data som stöder värdet av bolagets ledande program, ilixadencel. Artikeln, med titeln "Ilixadencel - An Allogeneic Cell-Based Anticancer Immune Primer for Intratumoral Administration" publicerades on-line i Pharmaceutical Research , American Association of Pharmaceutical Scientists officiella tidskrift. Artikeln finns via följande länk https://link.springer.com/article/10.1007/s11095-018-2438-x - Det är en ära för vårt forsknings- och utvecklingsteam på Immunicum att bli erbjudna att skriva denna omfattande översikt som tar upp ilixadencels verkningsmekanism mot bakrund av de senaste upptäckterna gällande immunaktivering mot cancer. Våra preklin
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum