Publication date: 30/04/2018
Ablynx [Euronext Brussels and Nasdaq: ABLX] today announced that it has successfully completed patient recruitment in the Phase IIb RESPIRE dose-ranging efficacy study of ALX- 0171, the Company's novel inhaled drug candidate to treat respiratory syncytial virus (RSV) infections.
A total of 180 infants (aged 1-24 months) diagnosed with RSV and hospitalised for a lower respiratory tract infection have been enrolled. The study consists of a sequential dose escalation part which enrolled 36 infants, followed by a parallel part in which 144 infants were randomly assigned to one of three dose groups of inhaled ALX-0171 or placebo. The study drug is administered once daily for three consecutive days.
Data from this Phase IIb study are expected to be reported in the second half of 2018.
Dr Robert K. Zeldin, Chief Medical Officer at Ablynx, commented:
"Completing study recruitment is an important step in the development of our inhaled anti-RSV Nanobody and we look forward to reporting the data later this year. Recruiting 180 infants with RSV younger than two years of age in just over 16 months confirms the urgent need for effective therapies in RSV. We thank everyone involved in this trial for their contribution and enabling us to evaluate ALX-0171 as a potential therapeutic for RSV infections, which today impact millions of infants and young children and place a significant burden on their families."
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 of 33 million infants and young children and the resulting hospitalisation of 3-4 million. RSV is associated with an estimated 3,000-8,500 deaths in infants <2 years globally per year, and it has been linked to an increased risk of asthma development later in life.
Current treatment of RSV infections is primarily focused on symptomatic relief, hence the need for an effective and specific anti-RSV therapeutic.
ALX-0171 is a wholly-owned trivalent Nanobody that binds to the F-protein of RSV, thereby inhibiting viral replication and neutralising 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. ALX-0171 has shown a potent anti-viral effect against a broad range of RSV strains in vitro and it has demonstrated a marked therapeutic effect following administration via nebulisation in a neonatal animal model for infant RSV infection.
Repeated daily inhalation of ALX-0171 was proven to be well-tolerated in multiple Phase I clinical studies in adults and a Phase I/IIa study in 53 hospitalised infants (aged 1-24 months) with a RSV infection. In addition, repeated daily inhalation of ALX-0171 had an immediate and significant impact on viral replication and an encouraging initial therapeutic effect in the Phase I/IIa study.
The randomised, double-blind, placebo-controlled, international, multi-centre dose-ranging Phase IIb RESPIRE study is evaluating three different doses of inhaled ALX-0171 in 180 hospitalised infants (aged 1-24 months) with a RSV infection. The sequential dose escalation part, which enrolled 36 infants, was completed in July 2017, after which the Data Monitoring Committee recommended to continue the study without changes to the protocol. The parallel dose part of the study in 144 infants was initiated in August 2017. The primary endpoint of the trial is to evaluate the anti-viral effect of treatment measured in samples taken by nasal swabs. Secondary endpoints include safety, pharmacokinetics and clinical activity determined by assessment of the composite Global Severity Score. Topline results from the RESPIRE trial are expected in H2 2018.
A randomised, double-blind, placebo-controlled, multi-centre Phase II study of ALX-0171 in 60 Japanese infants (aged 1-24 months) diagnosed with RSV and hospitalised for a lower respiratory tract infection is also ongoing since March 2018, with topline results expected in H2 2019.
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 more than 45 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; Merck & Co., Inc., Kenilworth, New Jersey, USA; Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
On 29 January 2018, Sanofi made an offer to acquire all of Ablynx's outstanding ordinary shares (including shares represented by American Depository Shares (ADSs), warrants and convertible bonds) at a price of €45 per share, which represents an aggregate equity value of approximately €3.9 billion. The proposed transaction was unanimously approved by both the Sanofi and Ablynx Board of Directors. The offer is comprised of two separate but concurrent tender offers: (i) a tender offer under the laws of Belgium for all of the outstanding shares, warrants and convertible bonds of Ablynx (the "Belgian Offer") and (ii) a tender offer under the laws of the U.S. for all of the outstanding shares held by U.S. holders and ADSs held by holders, wherever located (the "U.S. Offer"). The initial acceptance period of the tender offers commenced on 4 April 2018 and will expire at 5:00 p.m. ET / 11:00 p.m. CET on 4 May 2018, subject to extension.