Recce Pharmaceuticals Ltd. provided an update from its preclinical studies evaluating RECCE(R) 327 (R327) against the SARS-CoV-2 virus. The studies were conducted by Viroclinics, an independent, third-party contract research organization (CRO) based in the Netherlands. R327 demonstrated significantly efficacious activity against the SARS-CoV-2 virus in Syrian golden hamsters, the gold standard in preclinical COVID-19 studies.(1) The study aimed to investigate the therapeutic efficacy of R327 administered via the intranasal route against the delta variant of SARS-CoV-2 in the hamster model.

This route was chosen as SARS-CoV-2 infection is primarily located in the respiratory tract. The study consisted of five groups of 12 hamsters infected intranasally with SARS-CoV-2 prior to being treated twice daily, with either a low (200 mg/kg), mid (400 mg/kg), or high (600 mg/kg) dose of R327. Treatment commenced four (4) hours after the infection was initiated.

SARS-CoV-2 levels in infected animals were quantified using two techniques; qPCR, which measures viral genetic material and cannot distinguish between live and dead viruses, and TCID50, which measures live infectious viruses. Using these two different techniques, treatment with R327 was shown to significantly reduce SARS-CoV-2 levels in a dose- dependent manner in throat swab samples collected from these animals. This study provides proof-of-concept that intra- nasal treatment with R327 has the potential to reduce SARS-CoV-2 levels during infection.

Recce is delighted by the results, but further testing must be completed before confirming R327 to be safe or effective against the SARS-CoV-2 virus, such as human clinical studies. The Company has moved quickly to lodge further patent applications; with claims including, but not limited to: Composition/method of manufacture of RECCE anti-infectives, Use of R327 or R529 r the treatment of viruses havaving a lipid envelope or coat, examples being SARS-CoV-2 and coronaviruses, influenza viruses, HIV, hepatitis, Ross River and herpes viruses. Administration of R327 or R529 by oral, injection, inhalation and transdermal dose applications.

July 8,8, 2020, the Company announced that investigations into the efficacy of 27 had commenced. In those invnvestigations conducted by the CSIRO, R327 did not fulfill the agreed criteria required for the CSIRO to commence in- vivo animal testing (in ferrets). Accordingly, the Company and CSIRO have discontinued investigations related to R327, and the Company thanks CSIRO for its assistance.

Considering the positive study results from the SARS-CoV-2 in-vivo hamster study at Viroclinics, the Company will consolidate its focus on anti-viral (COVID-19) studies overseas.