Vectura Reports Successful Completion Of VR942 Phase I Clinical Study
Chippenham, UK – 3 June 2016: Vectura Group plc (LSE: VEC) ("Vectura"), which specialises in the development of products for the treatment of airways-related diseases, announces the successful completion of a Phase I clinical study (VR942-1-001) evaluating their innovative inhaled biologic immunomodulatory product ("VR942").
The study was successfully completed and 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. In this study, VR942 was safe and well tolerated at pharmacologically active doses. In addition, the investigation did not reveal any immunogenicity concerns and pharmacokinetic analysis demonstrated undetectable systemic exposure consistent with the mode of administration.
Outcomes from the pharmacodynamic assessment of once daily doses to mild asthmatics over a 10-day in-clinic period met a priori study success criteria. Rapid and durable attenuation of anti-inflammatory biomarker concentrations were statistically significantly greater for VR942 compared to placebo, indicating pharmacological engagement of a disease relevant target.
The generated data package supports the continued development of VR942 in severe inflammatory respiratory disease and progression of Phase II preparative activities. Detailed study outcomes will be presented at a future scientific conference.
VR942
In September 2013, Vectura Group and UCB (EBR: UCB; "UCB") announced that they had entered into a collaboration for the development of an innovative inhaled biologic immunomodulatory product ("VR942") in the area of severe inflammatory respiratory disease. The partnership, leveraging Vectura's dry powder inhaler/formulation and clinical/regulatory experience with UCB's biologics and immunology expertise, is focused upon the development of VR942 to completion of Phase II clinical proof-of-concept.
Financial terms of the collaboration have not been disclosed.
Clinical study VR942-1-001
VR942-1-001 (NCT02473939) was an in-clinic, placebo controlled trial that comprised two separate phases. Part 1 was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single ascending doses (or matching placebo) administered to 40 healthy volunteers equally distributed across five separate dosing cohorts.
Part 2 involved the once daily administration of repeat doses of VR942 or matching placebo to mild asthmatics over a 10-day period. Three dose levels were delivered in an ascending fashion to a total of 45 patients who remained in the clinic until Day 14 and returned for a final follow-up visit at Day 28. In addition to safety, PK and immunogenicity evaluation multiple daily pharmacodynamic measurements were performed.
James Ward-Lilley, CEO, commented:
"This study and collaboration is further evidence of Vectura’s role as a leading inhalation formulation and device partner. The collaboration with UCB is the first of its type in respiratory drug development where a large molecule antibody fragment is formulated and delivered as a dry powder for effective inhalation. The generation of data indicating a positive impact on biomarkers of inflammation presents an exciting prospect both for this antibody specifically and as a potential platform for other biologic developments in the future."
- Ends -
Enquiries
Vectura Group plc
+44 (0)1249 667700
Karl Keegan, Chief Corporate Development Officer
Fleur Wood, Director – Investor Relations and Corporate Communications
Citigate Dewe Rogerson
+44 (0)20 7638 9571
David Dible / Mark Swallow
Vectura is an independent pharmaceutical product development company that focuses on the development of inhaled pharmaceutical therapies for the treatment of diseases that affect or can be treated with drugs that act on the airways (airways diseases), incorporating inhaled device formulation and clinical development. This segment of the pharmaceutical market includes significant indications such as asthma and COPD, in addition to a wide range of other indications including cystic fibrosis, pulmonary fibrosis and other diseases of the lung.
Vectura has eight(1) 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 has development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Hikma (through its wholly-owned subsidiary, West-Ward Pharmaceuticals), Novartis, Sandoz, Baxter, GSK, UCB, Ablynx, Grifols, Janssen, Propeller Health and Tianjin KingYork Group Company.
(1) Advate® came off patent at the end of January 2016. Vectura does not expect to receive any material royalties from that product during its financial year ending 31 March 2017, or thereafter.
For further information, please visit Vectura's website at www.vectura.com.
The study was successfully completed and 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. In this study, VR942 was safe and well tolerated at pharmacologically active doses. In addition, the investigation did not reveal any immunogenicity concerns and pharmacokinetic analysis demonstrated undetectable systemic exposure consistent with the mode of administration.
Outcomes from the pharmacodynamic assessment of once daily doses to mild asthmatics over a 10-day in-clinic period met a priori study success criteria. Rapid and durable attenuation of anti-inflammatory biomarker concentrations were statistically significantly greater for VR942 compared to placebo, indicating pharmacological engagement of a disease relevant target.
The generated data package supports the continued development of VR942 in severe inflammatory respiratory disease and progression of Phase II preparative activities. Detailed study outcomes will be presented at a future scientific conference.
VR942
In September 2013, Vectura Group and UCB (EBR: UCB; "UCB") announced that they had entered into a collaboration for the development of an innovative inhaled biologic immunomodulatory product ("VR942") in the area of severe inflammatory respiratory disease. The partnership, leveraging Vectura's dry powder inhaler/formulation and clinical/regulatory experience with UCB's biologics and immunology expertise, is focused upon the development of VR942 to completion of Phase II clinical proof-of-concept.
Financial terms of the collaboration have not been disclosed.
Clinical study VR942-1-001
VR942-1-001 (NCT02473939) was an in-clinic, placebo controlled trial that comprised two separate phases. Part 1 was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single ascending doses (or matching placebo) administered to 40 healthy volunteers equally distributed across five separate dosing cohorts.
Part 2 involved the once daily administration of repeat doses of VR942 or matching placebo to mild asthmatics over a 10-day period. Three dose levels were delivered in an ascending fashion to a total of 45 patients who remained in the clinic until Day 14 and returned for a final follow-up visit at Day 28. In addition to safety, PK and immunogenicity evaluation multiple daily pharmacodynamic measurements were performed.
James Ward-Lilley, CEO, commented:
"This study and collaboration is further evidence of Vectura’s role as a leading inhalation formulation and device partner. The collaboration with UCB is the first of its type in respiratory drug development where a large molecule antibody fragment is formulated and delivered as a dry powder for effective inhalation. The generation of data indicating a positive impact on biomarkers of inflammation presents an exciting prospect both for this antibody specifically and as a potential platform for other biologic developments in the future."
- Ends -
Enquiries
Vectura Group plc
+44 (0)1249 667700
Karl Keegan, Chief Corporate Development Officer
Fleur Wood, Director – Investor Relations and Corporate Communications
Citigate Dewe Rogerson
+44 (0)20 7638 9571
David Dible / Mark Swallow
Vectura is an independent pharmaceutical product development company that focuses on the development of inhaled pharmaceutical therapies for the treatment of diseases that affect or can be treated with drugs that act on the airways (airways diseases), incorporating inhaled device formulation and clinical development. This segment of the pharmaceutical market includes significant indications such as asthma and COPD, in addition to a wide range of other indications including cystic fibrosis, pulmonary fibrosis and other diseases of the lung.
Vectura has eight(1) 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 has development collaborations and licence agreements with several global pharmaceutical and biotechnology companies, including Hikma (through its wholly-owned subsidiary, West-Ward Pharmaceuticals), Novartis, Sandoz, Baxter, GSK, UCB, Ablynx, Grifols, Janssen, Propeller Health and Tianjin KingYork Group Company.
(1) Advate® came off patent at the end of January 2016. Vectura does not expect to receive any material royalties from that product during its financial year ending 31 March 2017, or thereafter.
For further information, please visit Vectura's website at www.vectura.com.