The 1pm message30 Sep 2021 09:30
ACTIV-2 Phase II/III trial in US SNG001 (not requiring hospitalisation) commenced in February 2021... The Phase II trial has completed recruitment and a review is underway to determine whether SNG001 should be advanced into the Phase III part of the adaptive ACTIV-2 protocol. Results due by year end.
International Phase III trial (SG018), which commenced the recruitment of 610 hospitalised COVID-19 patients who require supplemental oxygen in January 2021, is expected to complete enrolment in November. Data readout now expected in Q1 2022 rather than second half 2021 as indicated at time of fund raising last year. Delay due to regulatoryy approvals. The last patients are expected to enter the trial by the end of November 2021, and results are expected early 2022.
Subject to a positive data read out from the Phase III trial, company will file an Emergency Use Authorization (EUA) with the FDA for patients requiring hospitalisation due to COVID-19. With Fast Track status granted by the FDA, Synairgen plans pre-submission meetings with the FDA and the EMA in the EU on the requirements and content for marketing application before end of 2021.
Despite supply chain challenges company expects to have tens of thousands of treatment courses available to the US market should an EUA be granted, with the potential to increase capacity to c.100,000 treatment courses per month equivalent to estimated peak potential monthly revenues of c.$300-350m.