Synairgen Advances to Phase 3 Trial of Inhaled COVID-19 Treatment SNG001
Synairgen Advances to Phase 3 Trial of Inhaled COVID-19 Treatment SNG001
UK biotech company Synairgen has commenced dosing in a phase 3 trial of SNG001, an inhaled formulation of interferon beta-1a, for hospitalized COVID-19 patients requiring supplemental oxygen. This follows encouraging results from a phase 2 study initiated in March last year.
Trial Details and Objectives
The phase 3 trial, named SG018, will involve 610 patients across approximately 20 countries. The treatment, delivered via a nebulizer, aims to address the lower than usual levels of interferon beta in the lungs of severely ill COVID-19 patients. Interferon beta-1a, already utilized in an injectable form for multiple sclerosis, has shown potential in earlier trials involving asthma and chronic obstructive pulmonary disease (COPD) patients.
Phase 2 Insights and Phase 3 Expectations
Preliminary results from the 100-patient phase 2 trial (SG016) indicated that patients treated with SNG001 had greater odds of improvement and recovered more rapidly from SARS-CoV-2 infection compared to those receiving a placebo. The trial utilized the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) as its main endpoint. Notably, there were no deaths among patients taking SNG001, compared to three in the placebo group, although the trial's size was insufficient to determine if this was due to the treatment or chance.
Regulatory Support and Future Prospects
The UK's National Institute for Health Research (NIHR) has granted the phase 3 trial Urgent Public Health status, facilitating support from the NIHR's clinical research network. Additionally, the FDA has awarded SNG001 fast-track status for COVID-19 treatment. Synairgen anticipates that results from the phase 3 trial could be available by summer, with emergency approvals possible by autumn.
Leadership Perspective
Synairgen CEO Richard Marsden emphasized the ongoing need for treatments, stating, "We believe this trial presents an opportunity for a significant UK scientific breakthrough and, if given the right support, our drug could rapidly assist with the global crisis." He highlighted the importance of treatments for cases where vaccines are not effective, for unvaccinated individuals, and in scenarios where virus mutations reduce vaccine efficacy.
Cost Considerations
A course of treatment with SNG001 is estimated to cost around £2,000, which Marsden describes as "good value for money" given the potential benefits and the context of the global pandemic.
This phase 3 trial represents a critical step in the development of SNG001 as a potential treatment for severe COVID-19 cases, offering hope for a significant advancement in the fight against the pandemic.