Partner completes trial enrolment

Vectura Group plc

Ablynx's anti-RSV Nanobody® completes enrolment of the first-in-infant Phase I/IIa safety study and extends the trial for younger infants using Vectura's FOX® device

Chippenham, UK - 18 December 2015: Vectura Group plc (LSE: VEC; "Vectura" or "the Company"), is delighted with the information released by Ablynx confirming that it has completed target enrolment of the first-in-infant Phase I/IIa safety study with its wholly-owned anti-RSV Nanobody, ALX-0171, and is on track to publish top line results in the first half of 2016.

Ablynx has also announced that following a positive recommendation from an independent Data Monitoring Committee (DMC) based on data available for the first 15 infants from the placebo-controlled part of this Phase I/IIa safety study, the age requirement for infants in the trial has been reduced from 3 months to 1 month. The Phase I/IIa study will now continue with an expansion cohort enrolling younger infants aged 1-5 months during the remaining RSV season in Northern Europe. This will enable the collection of additional data on ALX-0171 in a younger patient population. Results from this extension will be available in the second half of 2016.

VR465 - Global

ALX-0171 is a Nanobody drug candidate, administered through inhalation, for the treatment of respiratory syncytial virus (RSV) infection in infants. VR465 is being developed by our partner Ablynx and utilises Vectura's smart nebuliser technology device, the FOX®, to deliver the Nanobody to patients. The FOX® device used in this programme has been adapted for use with neonates and infants.

FOX®

The FOX® device is a hand-held, self-contained, battery powered inhalation system that delivers nebulised liquid drugs with high performance using a vibrating mesh technology. The mesh-based aerosolisation engine is proprietary to Vectura. As with all of Vectura's smart nebuliser delivery systems, the FOX® provides targeted inhalation therapy for applications where precise and targeted delivery to the lungs is needed. To achieve this, the device creates a liquid aerosol and co-ordinates delivery after the patient has inhaled using the FAVORITE (Flow And Volume Regulated Inhalation TEchnology) principle for precise delivery to the lungs. The FOX® inhalation system also makes use of a flow sensing/controlling value system, is rechargeable and can be Bluetooth®-enabled. FOX® is CE marked and 510(k) approved and in April 2014, gained a Red Dot Award for product design.

James Ward-Lilley CEO, commented:

"This development is a very positive step and we look forward to the release of the top line results from this safety study in the first half of 2016. This announcement demonstrates a validation of the technology from the acquisition of Activaero and is underpinned by the excellent relationship, combining the device capabilities of Vectura and the powerful Nanobody technology and development expertise of our partner. Vectura continues to be viewed as a partner of choice in the application of novel formulation and device technologies in the development of new medicines by companies seeking to address the unmet medical needs of patients with airway diseases."

-Ends-

Enquiries

About the Phase I/IIa safety inhalation study

In December 2014, Ablynx opened recruitment for the first-in-infant Phase I/IIa safety study with inhaled ALX-0171 in otherwise healthy infants (aged 3-24 months) diagnosed with RSV and hospitalised for lower respiratory tract infection. The study has recruited 35 hospitalised infants in multiple clinical centres in Europe and the Asia-Pacific region and consisted of two parts: 1) a lead-in phase with five infants who received inhaled ALX-0171, once daily, for three consecutive days; and 2) a placebo-controlled phase in 30 infants who received either placebo or inhaled ALX-0171, once daily, for three consecutive days. The primary endpoint of the study is safety and tolerability of ALX-0171. Secondary endpoints include clinical effect (including effect on feeding, respiratory rate, wheezing, coughing, general appearance and clinical scores), immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of inhaled ALX-0171.

About RSV and ALX-0171

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. It is the primary cause of infant hospitalisation and virus associated deaths in infants, with estimated global annual infection and hospitalisation rates of 34 million and 3-4 million respectively1. It is associated with an estimated 3,000-8,500 deaths in infants 2. In addition, RSV infections have been linked to an increased risk of asthma development later in life3. Current treatment of RSV infection is primarily focussed on symptomatic relief, hence the need for an effective and specific anti-RSV therapeutic.

ALX-0171 has been developed to address this unmet medical need and has first-in-class potential for the treatment of RSV infection in infants. It is a wholly-owned trivalent Nanobody that inhibits RSV replication and which neutralises RSV activity by blocking virus uptake into cells. The physical robustness of the Nanobody allows administration via inhalation directly to the site of infection, i.e. the respiratory tract including the lungs. ALX-0171 has shown a potent anti-viral effect against a broad range of RSV strains and it demonstrated to have a strong therapeutic effect following administration via nebulisation in a neonatal animal model for infant RSV infection4. Repeated daily inhalation of ALX-0171 was proven to be well-tolerated in multiple Phase I clinical studies, including a study in subjects with hyper-reactive airways. At the end of September 2014, the European Medicines Agency (EMA) approved the Paediatric Investigation Plan (PIP) for ALX-0171.

1 Nair et al, Lancet 2010

2 Byington et al, Pediatric 2014

3 Sigurs et al, Thorax 2010; Backman et al, Acta Pediatr 2014

4 Oral presentation at the 9² International RSV Symposium (November 2014); presentation available on the Ablynx

About Ablynx

Ablynx is a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has approximately 40 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Inc., Merck KGaA, Novartis, Novo Nordisk and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.

About Vectura

Vectura is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airways-related diseases (airways diseases). This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth $44 billion worldwide.*

Vectura now has eight products marketed by partners with growing global royalty streams and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura currently has disclosed development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Novartis, Sandoz, Baxter, GlaxoSmithKline, UCB, Ablynx, Grifols, Janssen Biotech and Tianjin KingYork Group Company.

Vectura develops products for airways diseases and owns formulation and inhalation technologies that are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura's business strategy.

For further information, please visit Vectura's website at www.vectura.com.

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.

 * Decision Resources 2014