Synairgen PLC has announced a significant funding boost of £18 million to support a Phase 2 clinical trial of SNG001, an investigational inhaled interferon beta treatment. The trial will focus on mechanically ventilated patients suffering from respiratory viral infections, a population with alarmingly high mortality rates. This funding aims to address the critical need for innovative treatment options in this patient group.
The funding, primarily backed by TFG Asset Management, will enable Synairgen to conduct a robust Phase 2 trial involving 450 patients. The primary endpoint of the trial is to determine whether SNG001 can significantly reduce mortality in this severely ill patient population, where mortality rates currently range between 25% and 45%.
Trial Design and Objectives
The Phase 2 trial, named INVENT, is designed to assess the efficacy of SNG001 in boosting the innate immune system within the lungs. SNG001 is administered directly into the lungs as an aerosol, aiming to restore and enhance the lungs' antiviral responses. The trial will evaluate the impact of SNG001 on reducing mortality, a key indicator of treatment success in this critical patient group.
Richard Marsden, CEO of Synairgen, emphasized the potential of SNG001 as a broad-spectrum antiviral agent. "SNG001 is a broad-spectrum antiviral offering potential against common cold, flu, and coronaviruses, which can lead to critical illness," Marsden stated. "By delivering SNG001 directly into the lungs as an aerosol, we aim to boost and restore the lungs' antiviral responses to improve patient outcomes."
The funding will not only support the trial's operational costs but also cover essential drug manufacturing and stability testing. This positions SNG001 as an attractive candidate for potential future partnerships with pharmaceutical companies, enhancing its prospects for broader clinical application.
Financial Details and Future Prospects
The £18 million funding is contributed by TFG Asset Management. Synairgen will issue 900 million new ordinary shares, pending shareholder approval at a General Meeting on 16 January 2025. Admission of the new shares to trading on AIM is expected at 8:00 a.m. on 17 January 2025.
If the trial demonstrates a significant reduction in mortality, SNG001 could become a valuable asset, attracting interest from pharmaceutical companies and paving the way for commercialization. The trial is expected to commence in early 2025, with interim analysis planned after 224 patients have been evaluated.
Mark Parry-Billings, Chairman of Synairgen, commented, "SNG001 has potential to reduce mortality in this high-risk group of mechanically ventilated patients being managed in intensive care units. The INVENT trial is designed to test this, and plans are underway to initiate this important trial in the coming months."
