BioIncept is preparing for a phase I/IIa clinical trial at a leading US medical center to evaluate the Safety and Efficacy of sPIF in Patients Diagnosed with Novel COVID-19.

The study will examine safety as well as the amelioration of symptoms and follow up to evaluate repair of tissue and organ damage.

BioIncept has conducted a systematic review of the data we have generated to-date as well as a review of the competitive landscape to evaluate whether sPIF could be relevant treating COVID-19 patients.

We strongly believe that sPIF can demonstrate a near term treatment effect of modulating IL-6 in COVID-19 positive patients, reducing the magnitude of the cytokine storm, and over the longer term will initiate repair to damaged tissues. sPIF’s relevant mechanism of action from our research is as follows:

• sPIF reduces the production of pro-inflammatory cytokines, importantly including IL-6 by peripheral blood T helper type 1 (Th1) cells that lead to tissue destruction throughout the body, including the lung, GI tract, brain, peripheral nerves, bone marrow, pancreas and elsewhere.

• sPIF stimulates the release of type 2 (Th2) pro-repair cytokines. A similar shift in circulating macrophage response (from the M1 phenotype to the M2 phenotype), together with reduction in oxidative stress, contributes to long-term tissue repair.

Further details of the trial will be released in due course.