An Oral Galectin Inhibitor in COVID-19-A Phase II Randomized Controlled Trial

Alben Sigamani; Kevin H Mayo; Michelle C Miller; Hana Chen-Walden; Surendar Reddy; David Platt

doi:10.3390/vaccines11040731

An Oral Galectin Inhibitor in COVID-19-A Phase II Randomized Controlled Trial

Vaccines (Basel). 2023 Mar 25;11(4):731. doi: 10.3390/vaccines11040731.

Authors

Alben Sigamani¹, Kevin H Mayo², Michelle C Miller², Hana Chen-Walden³, Surendar Reddy⁴, David Platt³

Affiliations

¹ Carmel Research Consultancy Pvt. Ltd., Bengaluru 560025, Karnataka, India.
² Department of Biochemistry, Molecular Biology and Biophysics, University of Minnesota, 6-155 Jackson Hall, 321 Church Street, Minneapolis, MN 55455, USA.
³ Pharmalectin India Pvt. Ltd., Rangareddy 500039, Telangana, India.
⁴ Department of Pulmonology, ESIC Medical College and Hospital, Sanath Nagar, Hyderabad 500038, Telangana, India.

Abstract

Background: SARS-CoV-2 vaccines play an important role in reducing disease severity, hospitalization, and death, although they failed to prevent the transmission of SARS-CoV-2 variants. Therefore, an effective inhibitor of galectin-3 (Gal-3) could be used to treat and prevent the transmission of COVID-19. ProLectin-M (PL-M), a Gal-3 antagonist, was shown to interact with Gal-3 and thereby prevent cellular entry of SARS-CoV-2 in previous studies.

Aim: The present study aimed to further evaluate the therapeutic effect of PL-M tablets in 34 subjects with COVID-19.

Methods: The efficacy of PL-M was evaluated in a randomized, double-blind, placebo-controlled clinical study in patients with mild to moderately severe COVID-19. Primary endpoints included changes in the absolute RT-PCR Ct values of the nucleocapsid and open reading frame (ORF) genes from baseline to days 3 and 7. The incidence of adverse events, changes in blood biochemistry, inflammatory biomarkers, and levels of antibodies against COVID-19 were also evaluated as part of the safety evaluation.

Results: PL-M treatment significantly (p = 0.001) increased RT-PCR cycle counts for N and ORF genes on days 3 (Ct values 32.09 ± 2.39 and 30.69 ± 3.38, respectively) and 7 (Ct values 34.91 ± 0.39 and 34.85 ± 0.61, respectively) compared to a placebo treatment. On day 3, 14 subjects in the PL-M group had cycle counts for the N gene above the cut-off value of 29 (target cycle count 29), whereas on day 7, all subjects had cycle counts above the cut-off value. Ct values in placebo subjects were consistently less than 29, and no placebo subjects were RT-PCR-negative until day 7. Most of the symptoms disappeared completely after receiving PL-M treatment for 7 days in more patients compared to the placebo group.

Conclusion: PL-M is safe and effective for clinical use in reducing viral loads and promoting rapid viral clearance in COVID-19 patients by inhibiting SARS-CoV-2 entry into cells through the inhibition of Gal-3.

Keywords: ProLectin-M; SARS-CoV-2; clinical trial; galectin-3; spike protein.

Grants and funding

This study was self funded by Pharmalectin, a unit of Bioxytran, Inc.