TIDMVEC
RNS Number : 3579Y
Vectura Group plc
21 August 2018
This contains inside information
Vectura Group announces positive findings from its VR647 Phase
II pharmacokinetic and mouthpiece methodology studies
Validating technology platforms and enabling progression of
Phase III programme
Chippenham, UK - 21 August 2018: Vectura successfully concludes
two paediatric studies to support the potential use of VR647, its
wholly-owned drug/device combination asset.
The first study evaluated the pharmacokinetics of budesonide
delivered using Vectura's VR647 Inhalation System to paediatric
asthma patients between four and eight years of age. The second
study was a methodology study, designed to evaluate the ability of
children from one to four years of age to use the VR647 Inhalation
System with a mouthpiece.
The pharmacokinetic and methodology studies suggests that the
VR647 Inhalation System may reduce delivery times and potentially
reduce steroid dose, versus marketed nebulised treatments in
children with asthma. The trials investigated children across
different age settings, and results from both studies provide high
confidence in the programme, supporting the progression of VR647 to
a Phase III programme.
Pharmacokinetic Study
This US study investigated 17 paediatric patients from four to
eight years of age with symptoms suggestive of asthma.
Pharmacokinetics were obtained for three different budesonide doses
delivered with the VR647 Inhalation System and an approved 1mg
budesonide dose delivered using a marketed nebuliser.
Highlights:
-- Budesonide pharmacokinetics indicate that the VR647
Inhalation System can achieve the same lung deposition in children
with a lower delivered dose than the marketed nebuliser delivery
system without compromising exposure or safety.
-- Potential to reduce budesonide treatment time by 50% or more
in children using the VR647 Inhalation System, compared with the
marketed product tested.
These results, subject to discussions with the FDA, will define
the dosing regimens to be tested in the pivotal Phase III program
to evaluate the efficacy and safety of VR647 Budesonide Inhalation
Suspension delivered by the VR647 Inhalation System.
Methodology study
This study assessed the ability of 40 children from one to four
years of age (inclusive) to use the VR647 Inhalation System
successfully, with a mouthpiece to inhale a fixed volume of
aerosol.
The study also evaluated the impact of the age of the child on
their need for hands-on support from a parent or caregiver.
Highlights:
-- Despite the current belief that children under 4 years of age
are unable to effectively use a mouthpiece, this trial demonstrates
that children >2 years of age are able to use the VR647
Inhalation System with a mouthpiece.
A mouthpiece is an efficient and convenient patient/nebuliser
interface that allows a tight control of the breathing pattern with
no loss of medication. Vectura is also developing a facemask for
children under 2 years of age.
Dr. Gonzalo de Miquel, Executive Vice President and Chief
Medical Officer, Vectura, commented: "There are very few approved
treatment options for children under 5 years of age. The results of
these studies support Vectura's confidence in our wholly-owned
VR647 product as a more convenient treatment option for children.
This product has the potential to reduce treatment times and the
steroid burden for this patient population, without compromising
exposure or safety. We look forward to outlining Phase III plans
with the FDA at the end of the year."
Dr. Leonard Bacharier, Professor of Paediatrics and Medicine at
Washington University School of Medicine, commented: "These studies
provide very encouraging and positive data, as they demonstrate
that the VR647 Inhalation System, with the mouthpiece, can easily
be used by young children. The real-time feedback and inhalation
control with the VR647 Inhalation System is a new way of treating
asthmatic children with budesonide, and has the potential to
improve compliance and efficacy in a patient population with
limited therapy options."
Ends
Meet The Expert Call
Dr. Gonzalo de Miquel, Executive Vice President and Chief
Medical Officer, Vectura, will be joined by Dr. Leonard Bacharier,
Professor of Paediatrics and Medicine at Washington University
School of Medicine, for a live conference call today at 14.30
BST/9:30 EDT to discuss the VR647 development programme and the
results of the two trials. There will be a short presentation
followed by an expert discussion on next steps for VR647. A copy of
the presentation will be available on Vectura's website 30 minutes
before the call. Link:
http://www.vectura.com/investors/presentations-webcasts/
Dial-in details:
Participant local dial-in: 020 7192 8000 (UK) and 1 631 510 7495
(US)
Participant free phone dial-in: 0800 376 7922 (UK) and 1 866 966
1396 (US)
Conference ID: 7992149
For more information, please contact:
Vectura Group plc +44 (0)7471 352 720
David Ginivan - VP Corporate Communications
Julia Wilson - Director Investor Relations
Consilium Strategic Communications +44 (0)20 3709 5700
Mary-Jane Elliott / Jessica Hodgson / David Daley
About VR647
VR647 (US) is Vectura's wholly-owned specialist pipeline
drug/device combination asset using the AKITA(R) JET innovative
smart nebuliser technology. VR647 comprises Budesonide Inhalation
Suspension, together with Vectura's novel proprietary VR647
Inhalation System, and is being positioned as an alternative
treatment for asthma in children in the US market.
Market opportunity: despite generic entry, the nebulised
budesonide market in the US remains a significant market
opportunity with sales of approximately $760 million[i] in 2017 and
stable volumes of >30m units[ii]. More than 50%[iii] of
nebulised budesonide patients are 8 years old and under in the US.
We believe VR647 will offer sufficient differentiation from
existing nebulised budesonide therapies to support the premium
versus generic pricing. As previously indicated, we continue to
explore partnering options for VR647.
About Vectura
Vectura is an industry-leading inhaled product formulation,
device design and development business offering a uniquely
integrated inhaled drug delivery platform. We develop inhalation
products to help patients suffering from airways diseases.
Vectura has eight key inhaled, two non-inhaled and ten oral
products marketed by partners with growing global royalty streams,
and a diverse partnered portfolio of drugs in clinical development.
Our partners include Hikma, Novartis, Sandoz, Mundipharma, Kyorin,
Baxter, GSK, UCB, Ablynx, Bayer, Chiesi, Almirall, Janssen, Dynavax
and Tianjin KingYork.
Vectura's strategy is to fully leverage its differentiated
technology and skills, maximising value by enhancing the delivery
and performance of inhaled products and through the development of
high-quality generic alternatives to branded therapies.
For further information, please visit Vectura's website at
www.vectura.com.
[i] Source: IQVIA MIDAS data
[ii] Source: IQVIA MIDAS data
[iii] Source: IMS Health - Budesonide Market Sizing By
Indication 2015
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END
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