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UCB presents UCB0107 anti-Tau immunotherapy Phase I study results at World Movement Disorders Conference®

· Results in healthy volunteers suggest UCB0107 well tolerated with an acceptable safety profile
· Study further supports progression of UCB0107 clinical development programme in patients with tauopathies, such as progressive supranuclear palsy (PSP) 

Brussels, Belgium, Wednesday September 25th, 2019, 07:00 (CEST): New data from a Phase I study,1 conducted in healthy volunteers, presented at the 2019 International Congress of Parkinson’s Disease and Movement Disorders®, Nice, France, suggest UCB0107, an anti-Tau immunotherapy treatment currently being investigated by UCB as a potential treatment for patients with tauopathies such as progressive supranuclear palsy (PSP), is well tolerated with an acceptable safety profile. 

Tau is a microtubule-associated protein expressed in the central nervous system, which supports with the assembly and stabilization of neuronal microtubules.2 In tauopathies, Tau becomes pathogenic, forming tangles, which cause cell damage and ultimately neuronal death.2,3,4 It is hypothesised that the spread of Tau protein from neuron to neuron underpins disease progression in tauopathies5 providing the rationale for antibody therapies.

Previous preclinical studies3,4 have already shown that the choice of epitope is an important efficacy determinant for therapeutic anti-Tau antibodies. This first in human, randomised, subject blind, investigator blind, placebo-controlled, single-ascending-dose study has been selected as a late breaking highlight by the MDS congress organisers, reflecting the importance of these data. 

The aim of the research was to evaluate the safety, tolerability and pharmacokinetics of UCB0107 in healthy volunteers.

 “We’re learning more and more about the role of Tau deposits and the extent to which they are closely linked to symptoms of neurodegeneration such as movement disorders, memory loss and dementia” explained Colin Ewen, UCB Development Lead, UCB0107. “Development 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 impacted by neurodegenerative diseases”.

The primary endpoint used in the study was incidence of adverse events. Data 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 cerebrospinal (CSF) PK parameters. 

52 healthy male adults were randomized and assigned to one of seven dose cohorts to receive UCB0107 or placebo by iv infusion. All participants completed the study. 

Over the course of the study, the most common treatment-emergent adverse event (TEAE) in the total UCB0107 and placebo groups was headache (15.8% and 35.7%, respectively). One severe TEAE of leg varicose ulceration was reported in one participant with a history of varicose veins and varicose-vein stripping. No serious or drug-related TEAEs were reported. There were no clinically relevant changes in other safety results. 

The UCB development process combines insights from patients and caregivers, collaborations with leading experts from around the world, and cutting-edge scientific methods to address important unmet medical challenges. This approach provides a uniquely holistic view about the unmet needs facing patients and the potential for an effective anti-Tau antibody in the treatment of neurodegenerative diseases”, explained Charl van Zyl, Head of Neurology Patient Value Unit & Executive Vice President, UCB. “These first in human safety and tolerability results support our belief in the potential for UCB0107 to provide value for people living with neurodegenerative disorders who currently have very limited or no treatment options. They validate our decision to continue the clinical development of this new asset.”

Results from this study, combined with results from pre-clinical research3,4 support progression of UCB0107 clinical development in patients with tauopathies such as PSP. 

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 the spread of Tau pathology.

For further information:  

Corporate Communications
France Nivelle  
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

Laurent Schots 
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com 

Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
 Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com 

Brand Communications

Jim Baxter, 
Neurology Communications, UCB
T+32.2.473.78.85.01 jim.baxter@ucb.com 

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7,500 people in approximately 40 countries, the company generated revenue of €4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements 
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. 

Additionally, information contained in this document shall not constitute an 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. UCB is providing this information as of the date of this document and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

References: 

  1. A randomised, placebo-controlled, first-in-human study with a central Tau epitope antibody – UCB0107. [Late breaking abstract 3]. Poster presented at the International Congress of Parkinson’s Disease and Movement Disorders® 22–26 September 2019, Nice, France
  2. Courade J-P et al. Acta Neuropathol. 2018;136(5):729–45. 
  3. Albert M et al. Brain. 2019;142:1736–50.
  4. Fontaine S et al. Cell Mol Life Sci. 2015;72(10):1863–79. 
  5. Ling H. J Mov Disord. 2016;9(1):3–13. 

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UCB MDS Sept 25 2019


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