Lyophilization and COVID19

Updated: Jul 20

SARS-CoV-2 is a new virus responsible for an outbreak of respiratory illness known as COVID-19, which has spread to several countries around the world.

Emerging infectious diseases, such as severe acute respiratory syndrome (SARS) and Zika virus disease, present a major threat to public health. Despite intense research efforts, how, when and where new diseases appear are still the source of considerable uncertainty.

One of the main technical challenges for vaccines is to improve on the old ways of manufacturing proteins, which are just too slow for responding to an epidemic. It is needed to develop platforms that are predictably safe, so regulatory reviews can happen quickly, and that make it easy for manufacturers to produce doses at a low cost and a massive scale. For antivirals, there will need to be an organized system to screen existing treatments and candidate molecules in a swift and standardized manner.

When Lyophilization comes handy

Currently a study is being conducted to evaluate the safety and efficacy of novel lyophilized therapeutic agents in hospitalized adult patients diagnosed with COVID-19.

The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between Remdesivir (the lyophilized formulation of Remdesivir contains water for injection, sulfobutylether beta-cyclodextrin sodium, and hydrochloric acid and/or sodium hydroxide) and a placebo.

There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants.

An independent data and safety monitoring board will actively monitor interim data to make recommendations about early study closure or changes to study arms. Randomization will be stratified by site and severity of illness at enrollment.

The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19. The secondary objectives of the study are to 1) evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by clinical severity, hospitalization, and mortality, and 2) evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm.

Anti-viral drug Favilavir has secured approval from the National Medical Products Administration of China to treat coronavirus Covid-19, according to media reports. China Daily reported that the Taizhou government in Zhejiang province announced the approval, which marks the authorization of the first drug against the new coronavirus.

Formerly Fapilavir, the drug was developed by Zhejiang Hisun Pharmaceutical. Fapilavir allegedly demonstrated efficacy with minor side effects in an ongoing 70-patient clinical trial in Shenzhen, Guangdong province. The drug’s generic version received the approval.

Even though no official step has been taken globally, it seems plausible that the possible treatment to COVID-19 will be a lyophilized drug.

This makes us think on how the process must be shorten and design space adjusted at best in order to reduce time to market and in these sort of crisis “time to cure”.