COVID19

The Problem: COVID19 remains among the leading causes of death worldwide.

Approved antiviral medications targeting the SARS-CoV-2 Mpro/3CL protease require co-administration of a human cytochrome P450 (CYP) inhibitor, resulting in serious drug:drug interactions that limit eligibility especially in the more vulnerable poly-medicated elderly patients.

Currently approved COVID19 antiviral medications have not affected the rates of clinical rebound, an important problem in management of this disease.

QUICK FACTS

Recent data indicates that 20.8% of [nirmaltrevir+ritonavir] -treated individuals had viral rebound (Edelstein, 2023, Annals of Internal Medicine)

Global COVID19 therapeutics market will be $16.2B by 2031 (source

Our clinical program will also evaluate whether longer treatment (10 days rather than current 5 days for [nirmaltrevir+ritonavir]) will eliminate viral rebound and avoid long COVID

Traws Pharma Solution: Develop investigational TRX01 (ratutrelvir), an MPro/3CL inhibitor for treatment of COVID19 with high potency.

Target the main protease (Mpro) of SARS-CoV-2, which is a highly conserved gene and a clinically validated target for COVID19 therapy.

Does not require co-administration of ritonavir, an inhibitor of CYP450 drug metabolism. By omitting ritonavir, we aim to reduce drug:drug interactions, potentially making a greater proportion of the population eligible for treatment. The eligibility issue is particularly important for elderly (often poly-medicated) and immunocompromised individuals who are frequently excluded from using therapy.

Development for once daily dosing; other Mpro covalent inhibitors (approved and in development) use a twice a day 5-day regimen. Their impact may be limited by virus rebound or long COVID.

Test a 10-day treatment regimen with TRX01 (ratutrelvir), aiming to extend the interval of virus suppression and reduce the incidence of symptomatic/virologic rebound.

A clinical trial objective: evaluate whether longer treatment suppresses rebound and whether this has an impact on the incidence of long COVID.

TRX01 (ratutrelvir) is in phase 1 clinical trials.