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
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Two London ex-Bankers launch first UK regulated Digital Asset Trading Platform and Crypto exchange accessible to Institutional Investors16.7.2018 17:37 | Pressemelding
LONDON, July 16, 2018 (GLOBE NEWSWIRE) -- UK's first native crypto exchange platform is on its way to become a reality. Sovren Exchange, a venture founded by a team of London-based banking executives, has announced an Initial Coin Offering (ICO) to begin Q3 of this year. For their launch, Sovren (SVRN) is raising a maximum of 10 Million USD (combination of Equity Funding and its own Sovren Token) to create a hybrid order book and brokerage exchange platform that uses a trading engine supported by Artificial Intelligence (AI) and Robotic Process Automation (RPA). Sovren will have a fully compliant platform that will support trading in derivates, equities, commodities and securities. The platform will use intelligent automation to address liquidity challenges and a 3rd party custodial service for additional protection with a European Bank. Sovren is supporting trading between all major crypto assets and fiat currencies like pounds, euros, and dollars, aiming for same day service and low,
TANTALEX Announces Entering into An Agreement with Respect to the Acquisition of an Exploitation Permit for the Historical Manono-Kitotolo Mine Tailings16.7.2018 16:48 | Pressemelding
TORONTO and MUNICH, Germany, July 16, 2018 (GLOBE NEWSWIRE) -- TANTALEX Resources Corporation (CSE:TTX) (FSE:1T0) ("TANTALEX" or the "Corporation"), is pleased to announce that its 90% owned subsidiary Buckell SAS ("Buckell") has entered into an assignment agreement (the "Agreement") to acquire Mines d'Or Resources ("Minor") 65% participation in a joint venture entity to which will be transferred the PER 13698 (Permis Exploitation Rejets) ("PER 13698"). PER 13698 grants exclusive rights to mine the tailings of the historical Manono-Kitotolo mine for lithium, tin and tantalum. The new entity will be named Société des Tailings de Manono ("STM") and will be owned 65% by Buckell, 30% by La Congolaise D'Exploitation Minière ("La Cominière") and 5% by Minor. The closing of the contemplated transaction by Buckell is subject to various conditions and payments, namely, but not limited to, the successful transfer and registration of the PER 13698 in the name of the newly created entity STM with
2018 Farnborough Air Show Marks Debut of Bombardier New ATMOSPHÈRE Cabin16.7.2018 12:00 | Pressemelding
MONTRÉAL, July 16, 2018 (GLOBE NEWSWIRE) -- Bombardier Commercial Aircraft unveiled the interior of the first CRJ Series aircraft with the new ATMOSPHÈRE cabin design on the opening day of the Farnborough International Air Show in the United Kingdom. Bombardier showcased the new cabin alongside launch operator Delta Air Lines and supplier Zodiac Aerospace during its air show inauguration event. "Our product is evolving, and this signature cabin design represents the latest innovation to our very successful regional jet program," said Fred Cromer, President, Bombardier Commercial Aircraft. "This cabin design will add value to airlines, the feedback has already been very positive as demonstrated with the recent momentum we have gained in the market." The CRJ900 aircraft on static display at the airshow is painted in Delta Air Lines livery and fitted with the ATMOSPHÈRE cabin. Bombardier will also emphasize its presence at the airshow from July 16-20 with a display of a Q400 aircraft in t
Aviation Solutions Provider Hawker Pacific to Collaborate with Pratt Whitney Canada on Array of Engine Maintenance Services16.7.2018 11:00 | Pressemelding
Agreement covers most PWC engine models and Digital Engine Services in Asia Pacific and the Middle East FARNBOROUGH, England, July 16, 2018 (GLOBE NEWSWIRE) -- Pratt & Whitney Canada (P&WC), a subsidiary of United Technologies Corp. (NYSE:UTX), today announced it has signed an agreement with Hawker Pacific under which the two companies will work together in a number of areas to further enhance the delivery of customer services and solutions. The comprehensive agreement spans most P&WC engine models and diagnostics and prognostics products across all segments: business aviation, general aviation, offshore, utility, regional aviation and defense and security. "Our agreement with P&WC is a testament to our continued commitment to delivering world class services and support to customers in Asia Pacific and the Middle East," said Doug Park, COO, Hawker Pacific. "We are thrilled to be working closely with P&WC to further extend their world class service network and deliver exceptional value
Fortuna reports production of 2.3 million ounces of silver and 14,557 ounces of gold for the second quarter of 201816.7.2018 11:00 | Pressemelding
VANCOUVER, British Columbia, July 16, 2018 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE:FSM) (TSX:FVI) is pleased to report production results for the second quarter of 2018 from its two operating mines in Latin America, the San Jose Mine in Mexico and the Caylloma Mine in Peru. The Company produced 2.3 million ounces of silver and 14,557 ounces of gold plus base metal by-products. Silver and gold production for the first six months totaled 4.7 million ounces and 29,597 ounces respectively; being 13 percent and 20 percent above the Company's mid-year projection. Fortuna is on schedule to produce 8.3 million ounces of silver and 48.3 thousand ounces of gold or 11.4 million Ag Eq1 ounces in 2018 in accordance with our production guidance (see Fortuna news release dated January 17, 2018). Second Quarter Production Highlights Silver production of 2,321,315 ounces; 10 percent increase over Q2 2017 Gold production of 14,557 ounces; in line with Q2 2017 Lead production of 7,186,541 pou
YouGov poll reveals UK adults are seeking innovative, digital payment experiences from their banks16.7.2018 01:04 | Pressemelding
New research showcases a list of innovative ways we'd like better protection against fraud and a more active role in controlling our payment cards· Switching cards on and off for better fraud controls, quickly reactivating blocked cards and mobile app based self-service is the future London, UK, July 16, 2018 (GLOBE NEWSWIRE) -- UK adults are ready for real-time interaction with their banks. The results of a recent YouGov survey, on behalf of Ondot, revealed today that online security and fraud prevention comes top in what Brits think banks should guarantee, with 60% wanting 'peace of mind' when using cards online. The survey also discovered that consumers are keen to play a much more proactive role in managing their personal finances. New ways of managing their card services before, during and after a payment; how, when and where cards are used and the ability switch your card 'on' and 'off' to create extra vigilance against fraud - are all important to today's card user. The omnibus
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom