Synairgen has reported that results from the home cohort of its SG016 Phase II clinical trial of inhaled SNG001 demonstrated a reduction in the rate of hospitalisation in Covid-19 patients.
SNG001 is a formulation with inhaled interferon beta (IFN-beta) for nebulisation, enabling its direct delivery into the lungs of the patients.
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The placebo-controlled trial analysed if SNG001 could prevent severe lower respiratory tract (LRT) illness caused by SARS-CoV-2. It enrolled 221 subjects across two cohorts – hospital and home.
The primary endpoint of the trial was the change in condition assessed using the WHO Ordinal Scale for Clinical Improvement (OSCI) during dosing.
The hospital cohort had 101 subjects in the hospital setting. Data showed that patients receiving SNG001 versus placebo were more likely to recover from severe LRT illness to an extent where they demonstrated ‘no limitation of activities’ (level one on the OSCI) without recuperation and decreased breathlessness.
In the home cohort, 120 at-risk subjects aged over 65 years or 50 years with a risk factor were enrolled in the home setting to assess SNG001’s ability in preventing severe LRT illness.
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By GlobalDataAccording to the trial data from this cohort, two subjects from the placebo group were hospitalised during the treatment period. The company added that severe LRT illness prevention could not be determined for the home cohort.
Also, patients in the home cohort were able to initiate self-administration of SNG001 at home.
Furthermore, an analysis of the combined data from both cohorts demonstrated that markedly or severely breathless subjects on SNG001 were 3.41 times more likely to recover as compared with those on placebo.
Synairgen CEO Richard Marsden said: “I am delighted by the finding that SNG001 treatment led to a threefold likelihood of recovery to ‘no limitation of activities’ in the markedly/severely breathless population compared to those on placebo in the home and hospital setting and that further analyses reinforce our previous findings.”
Marsden noted that SNG001 has the potential to lower burden on healthcare systems globally.
