Positive outcomes of the Phase I clinical study on VR942 presented today at the American Thoracic Society 113th annual conference

May 22, 2017 at 7:00 AM

Chippenham, UK – 22 May 2017: Vectura Group plc (LSE: VEC) (“Vectura”, “the Group”), an industry-leading device and formulation business for inhaled airways products, along with its co-development partner UCB (EBR: UCB) ("UCB"), announces they will present the positive outcomes of the Phase I clinical study (VR942-1-001) for their innovative inhaled biologic VR942 (UCB4144) at the American Thoracic Society 2017 International Conference (“ATS”) today, in Washington, D.C. This follows the Group’s announcement in June 2016 that the study met its primary objective of evaluating the safety and tolerability of once daily VR942 single or repeat doses, administered as a dry powder via inhalation, in healthy volunteers and mild asthmatics respectively.

This industry-leading collaborative development programme represents the first example of an inhaled anti-IL-13 monoclonal fragment antibody successfully completing a Phase I clinical study with safety, tolerability and pharmacodynamic data supporting the relevance of drug delivery direct to the lung and the site of IL-13 expression. This programme represents an exciting opportunity with biologics. Currently there are over 6 million patients with severe persistent asthma1 in major markets, of which 20% are uncontrolled2.

Particular highlights from the Phase I clinical study investigation may be summarised as follows:

  • VR942 was well tolerated by healthy volunteers and mild asthmatics with no difference in safety profile compared to placebo;
  • There were no reports of clinically significant immunogenicity after single and repeat dosing in healthy volunteers and asthmatics respectively; and
  • There was evidence of pharmacological engagement demonstrated by rapid, durable and statistically significant (p<0.05) reductions, relative to placebo, in fractional exhaled nitric oxide (FeNO) concentrations at two of the three doses administered once daily to asthmatics over a 10-day period.

Based on this data, Vectura and UCB are finalising preparation for a Phase II clinical study which is expected to commence in H2 2017. The Group’s costs for the ongoing development of this innovative product and technology platform are within the guidance range issued on 21 March 2017.

VR942 (Global) is a co-development programme between Vectura and UCB for the development of an innovative inhaled anti-interleukin-13 (IL-13) fragment antibody for the treatment of uncontrolled asthma. VR942, presented as a dry powder formulation for delivery via one of Vectura's proprietary dry powder inhaler (“DPI”) devices, benefits from a combination of Vectura’s large molecule formulation and device expertise and UCB’s biologics experience and capabilities.

James Ward-Lilley, Chief Executive Officer, commented:

“The successful completion of this Phase I clinical study illustrates the potential of VR942 as an attractive, novel and differentiated future treatment alternative to parenterally administered monoclonal antibodies that are currently indicated for the treatment of severe asthma. In addition, the successful development of our large molecule formulation and device technology provides an exciting and potentially highly valuable platform for the development of additional biological candidates in the future.”

The ATS Abstract Poster details are as follows:

22 May 2017 – Poster #606 (02:15pm – 02:45pm, EDT)

A4681 Session: A Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of VR942 (UCB4144) in Healthy Subjects and Repeated Doses in Mild Asthmatics

- Ends -

Enquiries

Vectura Group plc
Andrew Derodra – Chief Financial Officer
Fleur Wood –  Director Communications
Elizabeth Knowles – Director Investor Relations and Analysis
+44 (0)1249 667700
Consilium Strategic Communications
Mary-Jane Elliott / Sue Stuart / Jessica Hodgson
vectura@consilium-comms.com

+44 (0)20 3709 5700

About Vectura

Vectura, a FTSE250 company listed on the London Stock Exchange (LSE: VEC), is an industry-leading device and formulation business for inhaled airways products offering a uniquely integrated inhaled drug delivery platform. With our extensive range of device and formulation technologies, integrated capabilities and collaborations, we are a leader in the development of inhalation products, increasing our ability to help patients suffering from respiratory diseases.

Vectura has seven inhaled, four non-inhaled and ten oral products marketed by partners with growing global royalty streams, and a portfolio of drugs in clinical development, a number of which have licence agreements with several global pharmaceutical and biotechnology companies including Hikma, Novartis, Sandoz, Mundipharma, Kyorin, Baxter, GSK, UCB, Ablynx, Grifols, Bayer, Chiesi, Almirall, Janssen, and Tianjin KingYork. For further information, please visit Vectura's website at www.vectura.com. 

About CDP7766, IL-13 and uncontrolled asthma

CDP7766 is a UCB proprietary antibody fragment of a monoclonal antibody that binds with high affinity to IL-13 and prevents it from binding to the IL-13 receptor.

IL-13 is a pleiotropic Th2 cytokine, secreted from a variety of inflammatory cells including the airway epithelium, which plays a central role in the pathogenesis of asthma (Corren, 2013).

Levels of IL-13 are markedly increased in the sputum of uncontrolled asthmatics, contrasting with healthy controls in whom it is rarely detected (Saha et al, 2008). IL-13 is produced in the lung by leukocytes including T-lymphocytes, macrophages, eosinophils and mast cells (Berry et al., 2004; Brightling et al, 2003; de Vries, 1998). Within the asthmatic lung, IL-13 stimulates pro-inflammatory cytokine generation from airway leukocytes and structural cells, causes collagen deposition from fibroblasts, mucus secretion from goblet cells and promotes airway smooth muscle hyper-reactivity (Wills-Karp, 2004). IL-13 inhibition is therefore considered an attractive target in Th2 driven asthma.

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


1 Asthma Epidemiology, Decision Resources Group, 2016
2 Peters S, et al. 2006. Uncontrolled asthma: A review of the prevalence, disease burden and options for treatment. Respiratory Medicine.100, pp1139–1151

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