UCB Media Room: UCB0107 Phase I study results presented at MDS 2019

https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6HnxecAIldYqKLWWZ4DXqkv7JQcydg5dhc48TXTEph6jfoxRWYLQcSbQ4TJFe63= x54oxEEBKM30hVu0hFYUHkjqS2zl_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr= 0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADlCgvo8wv38= 5H8-2BCybh-2BoJqfDZZPuRSsWkO1QfOBQHJMuKMjhaA5Y7D8oTczU3Op67Fk75NaGlygPURgL8= T0hCoEfHwSeVJwZMsB4nh5XezdMrpftE6hJBXfBt0cNoSB4NxxxoTM8oLloXjDe-2FDZCkXbfsX= PpQKAZQbeFJC3epekzkvcnK6gQk7HzM-2FnDmpwpjo9j9c-2F4jtdunCE5cPowfPb0WWZJUQslg= jXb65MvrCmyimmgiVoBjH9L6acMeI9c-3D ** UCB presents UCB0107 anti-Tau immunotherapy Phase I study results at Wor= ld Movement Disorders Conference=C2=AE ------------------------------------------------------------ =C2=B7 Results in healthy volunteers suggest UCB0107 well tolerated with an= acceptable safety profile =C2=B7 Study further supports progression of UCB0107 clinical development p= rogramme in patients with tauopathies, such as progressive supranuclear pal= sy (PSP)=C2=A0 Brussels, Belgium, Wednesday September 25th, 2019, 07:00 (CEST): New data f= rom a Phase I study,^1 conducted in healthy volunteers, presented at the 20= 19 International Congress of Parkinson=E2=80=99s Disease and Movement Disor= ders^=C2=AE, Nice, France, suggest UCB0107, an anti-Tau immunotherapy treat= ment currently being investigated by UCB as a potential treatment for patie= nts with tauopathies such as progressive supranuclear palsy (PSP), is well = tolerated with an acceptable safety profile.=C2=A0 Tau is a microtubule-associated protein expressed in the central nervous sy= stem, which supports with the assembly and stabilization of neuronal microt= ubules.^2 In tauopathies, Tau becomes pathogenic, forming tangles, which ca= use cell damage and ultimately neuronal death.^2,3,4 It is hypothesised tha= t the spread of Tau protein from neuron to neuron underpins disease progres= sion in tauopathies^5 providing the rationale for antibody therapies. Previous preclinical studies^3,4 have already shown that the choice of epit= ope is an important efficacy determinant for therapeutic anti-Tau antibodie= s. This first in human, randomised, subject blind, investigator blind, plac= ebo-controlled, single-ascending-dose study has been selected as a late bre= aking highlight by the MDS congress organisers, reflecting the importance o= f these data.=C2=A0 The aim of the research was to evaluate the safety, tolerability and pharma= cokinetics of UCB0107 in healthy volunteers. =C2=A0=E2=80=9CWe=E2=80=99re learning more and more about the role of Tau d= eposits and the extent to which they are closely linked to symptoms of neur= odegeneration such as movement disorders, memory loss and dementia=E2=80=9D= explained Colin Ewen, UCB Development Lead, UCB0107. =E2=80=9CDevelopment = of a medicine with a positive safety and tolerability profile, which could = tackle the build-up of Tau, would offer hope to many millions of people imp= acted by neurodegenerative diseases=E2=80=9D. The primary endpoint used in the study was incidence of adverse events. Dat= a relating to other safety assessments (neurological examination, MRI, ECG,= clinical chemistry, haematology, coagulation, urinalysis and vital signs) = were also collected. Additional secondary endpoints measured serum and cere= brospinal (CSF) PK parameters.=C2=A0 52 healthy male adults were randomized and assigned to one of seven dose co= horts to receive UCB0107 or placebo by iv infusion. All participants comple= ted the study.=C2=A0 Over the course of the study, the most common treatment-emergent adverse ev= ent (TEAE) in the total UCB0107 and placebo groups was headache (15.8% and = 35.7%, respectively). One severe TEAE of leg varicose ulceration was report= ed in one participant with a history of varicose veins and varicose-vein st= ripping. No serious or drug-related TEAEs were reported. There were no clin= ically relevant changes in other safety results.=C2=A0 =E2=80=9CThe UCB development process combines insights from patients and ca= regivers, collaborations with leading experts from around the world, and cu= tting-edge scientific methods to address important unmet medical challenges= . This approach provides a uniquely holistic view about the unmet needs fac= ing patients and the potential for an effective anti-Tau antibody in the tr= eatment of neurodegenerative diseases=E2=80=9D, explained Charl van Zyl, He= ad of Neurology Patient Value Unit & Executive Vice President, UCB. =E2=80= =9CThese first in human safety and tolerability results support our belief = in the potential for UCB0107 to provide value for people living with neurod= egenerative disorders who currently have very limited or no treatment optio= ns. They validate our decision to continue the clinical development of this= new asset.=E2=80=9D Results from this study, combined with results from pre-clinical research^3= ,4 support progression of UCB0107 clinical development in patients with tau= opathies such as PSP.=C2=A0 Preparations are underway to initiate an adequate and well controlled study= in Q2 2020. About UCB0107 UCB0107 is a recombinant, humanised, full-length IgG4 monoclonal antibody, = targeting a central Tau epitope, which is being developed to block/reduce t= he spread of Tau pathology. For further information:=C2=A0=C2=A0 Corporate Communications France Nivelle =C2=A0 Global Communications, UCB T +32.2.559.9178 france.nivelle@ucb.com Laurent Schots=C2=A0 Media Relations, UCB =C2=A0 T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0 Investor Relations Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com Isabelle Ghellynck, =C2=A0Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 Brand Communications Jim Baxter,=C2=A0 Neurology Communications, UCB T+32.2.473.78.85.01 jim.baxter@ucb.com=C2=A0 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With 7,500 people in approxima= tely 40 countries, the company generated revenue of =E2=82=AC4.6 billion in= 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitt= er: @UCB_news Forward looking statements=C2=A0 This press release contains forward-looking statements based on current pla= ns, estimates and beliefs of management. All statements, other than stateme= nts of historical fact, are statements that could be deemed forward-looking= statements, including estimates of revenues, operating margins, capital ex= penditures, cash, other financial information, expected legal, political, r= egulatory or clinical results and other such estimates and results. By thei= r nature, such forward-looking statements are not guarantees of future perf= ormance and are subject to risks, uncertainties and assumptions which could= cause actual results to differ materially from those that may be implied b= y such forward-looking statements contained in this press release. Importan= t factors that could result in such differences include: changes in general= economic, business and competitive conditions, the inability to obtain nec= essary regulatory approvals or to obtain them on acceptable terms, costs as= sociated with research and development, changes in the prospects for produc= ts in the pipeline or under development by UCB, effects of future judicial = decisions or governmental investigations, product liability claims, challen= ges to patent protection for products or product candidates, changes in law= s or regulations, exchange rate fluctuations, changes or uncertainties in t= ax laws or the administration of such laws and hiring and retention of its = employees.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. UCB is providing this information as of the date of this document an= d expressly disclaims any duty to update any information contained in this = press release, either to confirm the actual results or to report a change i= n its expectations. There is no guarantee that new product candidates in the pipeline will prog= ress to product approval or that new indications for existing products will= be developed and approved. Products or potential products which are the su= bject of partnerships, joint ventures or licensing collaborations may be su= bject to differences between the partners. Also, UCB or others could discov= er safety, side effects or manufacturing problems with its products after t= hey are marketed. Moreover, sales may be impacted by international and domestic trends toward= managed care and health care cost containment and the reimbursement polici= es imposed by third-party payers as well as legislation affecting biopharma= ceutical pricing and reimbursement. References:=C2=A0 1. A randomised, placebo-controlled, first-in-human study with a central Ta= u epitope antibody =E2=80=93 UCB0107. [Late breaking abstract 3]. Poster pr= esented at the International Congress of Parkinson=E2=80=99s Disease and Mo= vement Disorders=C2=AE 22=E2=80=9326 September 2019, Nice, France 2. Courade J-P et al. Acta Neuropathol. 2018;136(5):729=E2=80=9345.=C2=A0 3. Albert M et al. Brain. 2019;142:1736=E2=80=9350. 4. Fontaine S et al. Cell Mol Life Sci. 2015;72(10):1863=E2=80=9379.=C2=A0 5. Ling H. J Mov Disord. 2016;9(1):3=E2=80=9313.=C2=A0 GenericFile UCB MDS Sept 25 2019 (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jS= YfZdO-2F12d8lSllQBx1W27HkUdGSImvHQ6HnxecAIldYqKLWWZ4DXqkv7JQc6eVKOojQxpUHby= Gr8zUYy2GauIh0hCKYdG7wJkww9ig-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFR= w6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADlCgvo8= wv385H8-2BCybh-2BoJqfDZZPuRSsWkO1QfOBQHJMuKMjhaA5Y7D8oTczU3Op67Fk75NaGlygPU= RgL8T0hCoEfHwSeVJwZMsB4nh5XezY0qCHX-2Ff8Wi9VpvUqCFPdH9dlpAHMA-2FdjkqOQW1x-2= FPR9inl7grw0jC2StfcTrxYQP0W7i-2FAbB1P6ea3PDbTn3qCeFlhD5V0jIXFYs7mz6RRQ5jqLx= CYaTN-2Bl3Mgq90bQYCchTdAmZmj2i32ulHC1kE-3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQ= Bz2p53T0v-2BoEIvbo6vDi8C-2BOyFzyb6obo-2BzKSgNKq4mrm1JyMSHIopAavfsTIUjppEe5-= 2FC8vXB56QSSMWde3AxPKgkTB2jdFVMSkBkBlrnOuXTiCL-2FFlSIAJ9amUksf9Fr4UyT5lk6ZD= n4vDar5At-2F4-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZT= jzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsADlCgvo8wv385H8-2BCybh-2= BoJqfDZZPuRSsWkO1QfOBQHJMuKMjhaA5Y7D8oTczU3Op67Fk75NaGlygPURgL8T0hCoEfHwSeV= JwZMsB4nh5XezW7xKBlmUEPoBgOo1D6LHoB8k330kRUAn8t6eNdg0RU2QPuAMCWu9CmMWEfP-2F= OfPfYimvyNruGss2A5qFTDjAUaMpoXgwwbOPCWc31sVLenGD4cCLvidA4WR1X2c9EiF4t6zOwS8= AVc5JuKbAkJSLhQ-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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