Nyrada Inc. provided an update on the progress of its Cholesterol-Lowering program. As a result of scale-up drug manufacturing delays caused by COVID-related lockdowns in Shanghai, China, the Phase I first-in-human study for Nyrada's Cholesterol-Lowering Program is now expected to commence during the first half of CY2023. The main driver of the delay was the inability of employees of the contract manufacturing organisation (CMO) engaged by Nyrada to access laboratory sites while the extended lockdown remained in place.

The required preclinical safety and toxicology studies are still expected to commence in Third Quarter CY2022. Substantial efforts have been made by the CMO to minimise the impact of the COVID-related lockdowns on drug manufacturing timelines, including the deployment of additional personnel and resources in an attempt to recover lost time. The primary objective of the Phase I study is to evaluate Nyrada's drug candidate for safety and tolerability.

A secondary endpoint will assess blood cholesterol levels in cohorts treated for 14 days with Nyrada's drug candidate as a preliminary indication of the drug's efficacy in humans. Pleasingly, the European Patent Office has formally granted the composition of matter patent for the Company's novel compounds inhibiting PCSK9, providing protection for Nyrada's intellectual property relating to its PCSK9 inhibitor technology until 16 March 2038. The patent was provisionally granted, as announced 17 May 2022.

Nyrada now has patent protection for the compounds in both the US and European Union.