Sng10 Sep 2025 14:43
Dear Shareholders,Business UpdateThe Company is pleased to be writing to you today to update you on the Company's progress inconnection with the Phase 2 (INVENT) clinical study and to give you information on some otherdevelopments.Phase 2 INVENT Clinical StudyThe Company has spent much of 2025 preparing for the start of the INVENT study: a large phase2 study to investigate SNG001 (inhaled interferon-beta) in mechanically-ventilated patients infectedwith a range of respiratory viruses. If the study is positive, it is structured (with mortality as theprimary endpoint) and powered to provide, in our view, a very compelling basis to proceed tophase 3. The essential preparatory work has included a comprehensive and cross-functionalprogramme of activities, with important and positive progress in at least the six main areas whichare outlined below.In summary, the programme plan maintains delivery of the interim analysis of the study in mid2026 and the final analysis in mid-2027. As with all clinical studies, not least in such a specialisedintensive care unit setting, there are a number of risks which we are seeking to mitigate. That said,we are very encouraged by the progress made in the period, as follows.· Establishing a network of more than 60 clinical study sitesWorking in partnership with our selected global clinical research organisation, we haveconducted detailed feasibility of in excess of 200 clinical sites and have identified suitableclinical investigators and hospital centres in the US, UK and four European countries, whohave the necessary skills and experience to execute the study. The group of carefullychosen clinical sites represents the fundamental expert network which is clearly essentialto execute such a specialised study in the intensive care setting.· Securing regulatory agency and ethics committee approvalsSignificant progress has been made towards securing the approvals which are mandatedprior to initiation of patient recruitment. The novel and specialised aerosol technologybeing employed to deliver SNG001 eficiently to the lungs of patients whilst on invasivemechanical ventilation has necessitated separate regulatory agency applications in the UKand in the four separate European countries, as a result of specific European medicaldevice regulations. These device-focused applications have been submitted in parallelwith drug product-focused applications to the regulators. In parallel, in the US, we haveundertaken a formal advice interaction with the Food and Drug Administration (US FDA)and incorporated the agency's feedback in the clinical study protocol. Additionally, wehave followed the FDA's request for further characterisation of SNG001 delivery tomechanically-ventilated patients. The majority of this laboratory work was executed inhouse by the Company's science team and demanded development of selected newanalytical methods prior to an intense period accelerating the studies and reporting theresults to the agency. We were delig
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