XBiotech Announces Upcoming Phase 2 Clinical Studies in Dermatology
XBiotech to Launch Two Phase 2 Clinical Studies to Study Subcutaneous Administration of MABp1 for Treatment of Hidradenitis Suppurativa and Atopic Dermatitis
AUSTIN, Texas, April 16, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that it would evaluate a new subcutaneous formulation of the Company's True Human(TM) monoclonal antibody, MABp1, in two separate Phase 2, open label, dose escalation studies in patients with moderate to severe Atopic Dermatitis (AD) and Hidradenitis Suppurativa (HS). The Company is conducting final preparations for study launch including the first clinical site initiation scheduled later this month.
Francisco Kerdel, M.D., founder of Florida Academic Dermatology Centers and the Study Chair for the Atopic Dermatitis study, commented, "The antibody targeting Interleukin-1 alpha represents potentially a new era in the management of inflammatory skin disorders. MABp1 is a first-of-its-kind being isolated from a human immunoregulatory response that blocks inflammation. New therapies are needed and we are excited about the potential for MABp1 in the clinic."
Alice Gottlieb, M.D., Ph.D., Professor of Dermatology at New York Medical College and Study Chair for the Hidradenitis Suppurativa study, commented, "We need new targets for therapies for Hidradenitis Suppurativa (HS). The development of adalimumab, a TNF blocker, for HS represented a major advance, however, patients still experience inadequate responses. Targeting IL-1 alpha with the monoclonal antibody MABp1 may provide more complete clinical responses and new hope for patients suffering with HS."
MABp1 is a human-derived antibody which targets and neutralizes IL-1 alpha (IL-1A), an inflammatory cytokine that plays a key role in the pathophysiology of a wide range of inflammatory skin disorders1. 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. Dose ranging of the Company's new subcutaneous formulation for MABp1 is planned to be studied in 4 week and 12 week open label treatment regimens for AD and HS. These findings will establish the basis for further randomized studies with the subcutaneous formulation.
The phase 2, open label, dose escalation multicenter study will consist of two dose cohorts of MABp1 in patients with moderate to severe HS. Patients entering the study will not have received any previous approved biological therapies for the treatment of HS. Ten patients will receive a total of 12 weekly 200mg subcutaneous injections of MABp1. Following a safety assessment for patients in the first dose cohort, ten patients will receive 12 weekly 400mg subcutaneous injections of MABp1. Patients will be followed for 12 weeks to allow for assessment of safety and preliminary efficacy. Various efficacy measures will be assessed including: Hidradenitis Suppurativa Clinical Response (HiSCR) from baseline to 12 weeks, changes in patient reported outcomes from baseline to week 12 including Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease and VAS for pain, assessment of Physician's Global Assessment (PGA), Disease Severity Score and modified Sartorius score at week 12, and change in inflammatory lesion count.
The phase 2, open label, dose escalation multicenter study will consist of two dose cohorts of MABp1 in patients with moderate to severe AD. 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 Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses5 ,6. Therefore, HS is often devastating for patients with significant impact on quality of life 7. The Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher than any other skin disorder8. Traditional treatments comprise of antibiotics, antiandrogens and surgery. The global prevalence for HS is estimated at up to 4% of the population 2.
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-1A and may be a key source of inflammatory stimulus in AD. IL-1A is present on leukocytes, where its role in leukocyte trafficking and infiltration may represent a key step in the chronic inflammation of AD. IL-1A is a key inducer of matrix metalloproteinases activity which could be directly involved in the epithelial barrier breakdown in AD9. Loss of regulation of IL-1 results in systemic inflammation with extensive skin involvement10.
About True Human(TM) Therapeutic Antibodies
Unlike previous generations of antibody therapies, XBiotech's True Human(TM) antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech's True Human antibodies have the potential to harness the body's natural immunity to fight disease with increased safety, efficacy and tolerability.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human(TM) proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. 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 1A, 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 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
6 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
7 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.
8 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 2008; 59: 695-701.
9 Han et al. Interleukin-1alpha-induced proteolytic activation of metalloproteinase-9 by human skin. Surgery. 2005 Nov;138(5):932-9.
10 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
Resverlogix Provides Unrestricted Educational Grant for Epigenetic Symposium at International Renal Congress25.5.2018 07:45 | Pressmeddelande
CALGARY, Alberta, May 24, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that on Friday, May 25, 2018, at the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress in Copenhagen, Denmark, the Company is supporting a symposium titled: "Epigenetics in CKD & CVD: A potential breakthrough therapy?" The symposium highlights the role of epigenetics and BET-inhibition in chronic kidney disease and cardiovascular disease, especially in patients with diabetes mellitus, and the significant unmet need that still exists in this patient population. The symposium is co-chaired by Vincent M. Brandenburg, MD - Nephrologist, Aachen, Germany and Kamyar Kalantar-Zadeh, MD - UC Irvine School of Medicine, Irvine, CA, USA, both leading scientists also serving as advisors to Resverlogix's Renal program. The speakers and agenda are as follows: Introduction Vincent M. Brandenburg, MD - University Hospital of the RWTH
Atico Reports Consolidated Financial Results for the First Quarter of 201824.5.2018 22:30 | Pressmeddelande
(All amounts expressed in US dollars, unless otherwise stated) VANCOUVER, British Columbia, May 24, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the "Company" or "Atico") (TSX.V:ATY) (OTC:ATCMF) today announced its financial results for the three months ended March 31, 2018, posting a net income of $0.4 million. Fernando E. Ganoza, CEO and Director, commented, "The strong production and all-in sustaining cash cost of $1.85 achieved this quarter is not reflected in the financial results as a large concentrate shipment was delayed to the second quarter, along with the revenue associated with those tonnes. The shipping schedule is expected to stabilize during the second quarter, where we will then benefit from the additional shipped concentrate and recognized revenue. We anticipate strong financial results in the next quarter." Mr. Ganoza continued, "Our emphasis will continue to be on further strengthening our balance sheet, improving production costs and most importantly regional
Elemica Reports Double Digit Network Growth and Announces New Product Innovations in First Quarter 201824.5.2018 18:18 | Pressmeddelande
Helping Process Manufacturers Undergo Digital Transformation Leads to Introduction of New Transformative Solutions WAYNE, Pa., May 24, 2018 (GLOBE NEWSWIRE) -- Elemica, the leading Digital Supply Network for process manufacturing industries, announces the company's first quarter results of 2018 highlighting substantial network growth and new product innovations. The Elemica Digital Supply Network had significant network expansion in the first quarter with traffic growing 10 percent year-over-year in Q1. Shipment traffic grew substantially based on new product expansions of Elemica Trace. "Elemica's growth can be attributed to our clients needing our expertise and technology to undergo a Digital Transformation that connects, automates, anticipates and transforms their enterprise for their business growth initiatives," said John Blyzinskyj, CEO of Elemica. "Our digital supply network enables businesses to grow their top and bottom lines, mitigate risk and improve customer satisfaction ac
Luxembourg Announced as SNOMED International's Newest Member24.5.2018 15:16 | Pressmeddelande
London, United Kingdom, May 24, 2018 (GLOBE NEWSWIRE) -- SNOMED International and Agence eSanté Luxembourg are pleased to announce that Luxembourg has joined the organization as its thirty-second Member. Luxembourg, one of the leading nations in the area of information and communication technology, has set the development of eHealth technologies as a high priority. Agence eSanté, Luxembourg's national agency for the exchange and sharing of medical data, has set an overall mission to facilitate clinical information exchange both within Luxembourg and across other international actors. To work towards this reality, the agency has taken part in discussions about standardization across Europe, a contributing building block achieved with its membership in SNOMED International. With their membership, Agence eSanté has committed their support for the use of structured clinical terminology. When applied to the health sector, interoperability ensures that information systems, and through them h
SEMAFO Signs Underground Mining Services Contract with AUMS24.5.2018 14:00 | Pressmeddelande
MONTREAL, May 24, 2018 (GLOBE NEWSWIRE) -- SEMAFO Inc. (TSX:SMF) (OMX:SMF) reports that it has signed a mining services contract with African Underground Mining Services ("AUMS") to provide turnkey mining services for Siou underground. AUMS is a well-known and reputable mining contractor with underground experience in Burkina Faso and across Africa. Under the mining services contract, AUMS will be responsible for supplying the mining fleet and a skilled labour force for Siou underground in addition to ensuring development, production and auxiliary services. SEMAFO will provide technical services including geology and engineering as well as leveraging the existing surface infrastructure at Mana. The mining services contract has a term of 70 months. The economic terms of the mining services contract are consistent with the economics presented in the Mana pre-feasibility study filed March 29, 2018 on SEDAR. Preparatory work has already commenced on Siou underground with full project deplo
Merus Announces First Patient Dosed in Phase 1 Clinical Trial of MCLA-158 in Patients with Solid Tumors24.5.2018 13:00 | Pressmeddelande
- IND Accepted in April by the U.S. FDA for MCLA-158 - UTRECHT, The Netherlands, May 24, 2018 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States. MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal grow
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum