Sound Pharmaceuticals is all set to launch two Phase II clinical trials of an oral capsule, SPI-1005, for treating patients with moderate or severe Covid-19.
Developed for various neurotologic, neuropsychiatric, and respiratory indications, SPI-1005 is a capsule with a small molecule called ebselen.
The latest development comes after Sound Pharmaceuticals received a Cooperative Grant award worth $3.1m from the US National Institutes of Health (NIH) unit National Center for Advancing Translational Sciences (NCATS) for evaluating SPI-1005.
Sound Pharmaceuticals co-founder and CEO Dr Jonathan Kil said: “We are honoured to receive NIH funding for this novel therapeutic application of ebselen in Covid-19.
“To our knowledge, these are the first Phase II studies of an Mpro or PLpro inhibitor in moderate and severe Covid-19.”
The two randomised, double-blind, placebo-controlled trials will enrol 120 subjects with moderate or severe Covid-19. They will receive SPI-1005 or placebo for seven or 14 days.
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Furthermore, the company will assess whether SPI-1005 can enhance the body’s inflammatory and cellular immune response to Covid-19.
In a separate development, Moleculin Biotech and IQVIA Biotech are set to initiate potential clinical trials of the former’s drug, WP1122, for treating Covid-19.
Moleculin Biotech chairman and CEO Walter Klemp said: “Over the last quarter, we completed our pre-clinical data, interviewed CRO’s and decided that IQVIA Biotech has the experience and reach to best serve our clinical needs for this project.
“In addition, considering that the active ingredient in WP1122 is 2-deoxy-D-glucose (2-DG) and that 2-DG has now shown efficacy in a Phase II clinical trial conducted by an unrelated drug developer outside of the US, we believe that a sufficient efficacy rationale for WP1122 already exists to begin clinical trials.”
Initially developed as a potential cancer drug, WP1122 was designed to boost the drug-like properties of 2-DG, specifically by enhancing circulation time and tissue and organ uptake and concentration.