Pulmotect has announced topline results from one of two Phase 2 trials of its PUL-042 immunostimulant inhalation solution demonstrating that PUL-042 therapy significantly reduced the time to respiratory symptom improvement in early-stage COVID-19 patients. The company announced its plans to initiate the two trials in May 2020 and later announced that the US Department of Defense provided a grant worth up to $6 million to support the studies.
The trial enrolled 101 patients who received either a single dose of PUL-042 on Day 1, Day 3 and Day 6 of the trial or a nebulized placebo on those days. Both groups also received standard of care. For patients who received PUL-042, median time to improvement of respiratory symptoms 6 days compared to 9 days for the placebo group. For improvement of cough, the median time for the PUL-042 group was 7 days compared to 11 days for the placebo group. According to the company, PUL-042 was well tolerated with no drug-related serious adverse effects.
Pulmotect CEO Colin Broom said, “I am excited about the topline results with PUL-042 and the shortening of time to symptoms improvement for patients with early COVID-19, which could have significant health and economic benefits as the global pandemic continues to unfold. As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants and has potential utility for other patient populations which we plan to explore including immunosuppressed cancer patients.”
Read the Pulmotect press release.
