MHRA grants approval of Phase 1 clinical trial, expected to start in H2 2022
Alderley Park, Cheshire, U.K – Infex Therapeutics, a leader in critical-priority infectious diseases, is pleased to announce it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to begin the Phase 1 study of its RESP-X programme. RESP-X Is a new anti-virulence therapy to treat Pa infections in non-cystic fibrosis bronchiectasis (NCFB) patients, a chronic and debilitating respiratory disease for which there are currently no approved treatments.
In-licensed from Japanese pharma company Shionogi, RESP-X is a novel humanised monoclonal antibody designed to help the body tackle Pa infections, a hard-to-treat drug-resistant pathogen recognised by the WHO as a critical threat to human health. It does not kill the bacteria directly but deactivates one of its critical mechanisms, enabling the immune system to clear the infection.
NCFB is a disease defined by an irreversible and progressive dilatation of bronchi due to chronic bronchial inflammation. It is characterised by periods of stable disease, with flare-ups, known as “exacerbations”, that increase in frequency and severity over the patient’s lifetime. There are at least eight million NCFB patients in major markets, of which 30% have chronic Pa colonisation. In the UK, the British Lung Foundation estimates there are in excess of 30,000 NCFB patients.
NCFB exacerbations are closely associated with acute bacterial infections, with Pa being one of the leading causes. In most severe cases, patients have multiple exacerbations per year resulting in high hospitalisation and mortality rates. As the disease progresses there are serious economic impacts for patients and healthcare systems.
The Phase 1a/b clinical study is expected to start in H2 2022. It will be a single centre, first-in-human, double-blind, placebo-controlled, intravenous single ascending dose study, to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and immunogenicity of RESP-X in healthy subjects and NCFB patients. Patient safety, tolerability and pharmacokinetics will be assessed at each dose prior to escalation.
Having established the appropriate dose in healthy volunteers, the second part of the study will be in NCFB patients (selected to have stable NCFB and be colonised with Pa) and will look for exposure and early markers of efficacy.
Dr Peter Jackson, CEO of Infex Therapeutics, said: “RESP-X is our first programme to enter the clinic and this is a significant milestone for the company. NCFB is a neglected, chronic condition that results in progressive respiratory decline and lung damage. These patients are seriously at risk of becoming chronically infected with Pseudomonas aeruginosa, a debilitating bacterial infection, impacting millions of patients worldwide, for which there are currently no approved treatments. RESP-X represents an important new treatment option and we look forward to progressing it through the clinic.”