Traws Pharma Completes Initial Dosing in Phase 1 COVID Therapy Trial

Traws Pharma, Inc., a clinical-stage biopharmaceutical company, has completed dosing in the first cohort of its first-in-human Phase 1 study of travatrelvir (TRX01), an orally-available protease inhibitor developed for the treatment of COVID-19. The study aims to evaluate the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers, with no safety concerns reported so far.

Werner Cautreels, Ph.D., CEO of Traws Pharma, emphasized the persistent global health threat posed by COVID-19, particularly to individuals aged 65 and above. He expressed optimism that travatrelvir could represent a significant advancement in the treatment of SARS-CoV-2, pending further study results. The company expects to release topline data from the Phase 1 study by the second half of 2024, followed by the initiation of an international Phase 2 safety and efficacy study.

Robert R. Redfield, M.D., Chief Medical Officer of Traws Pharma and former director of the US Centers for Disease Control (CDC), highlighted the unique profile of travatrelvir. In preclinical trials, it demonstrated activity against multiple SARS-CoV-2 variants and did not require co-administration with ritonavir, a common antiviral booster. This characteristic might allow travatrelvir to avoid drug-drug interactions and potentially permit broader patient use. The pharmacokinetic profile of travatrelvir may support a dosing regimen that minimizes the risk of viral rebound, positioning it as a potentially best-in-class treatment.

Travatrelvir targets the SARS-CoV-2 Mpro (3CL protease) and has shown in vitro activity against the original virus strain as well as the delta and omicron variants. It has demonstrated higher activity than nirmatrelvir, Pfizer’s Mpro inhibitor, in preclinical studies. Additionally, travatrelvir did not necessitate co-administration with a CYP inhibitor like ritonavir, which may allow for wider patient use due to fewer drug interactions. The drug’s pharmacokinetic profile suggests that a once-daily, 10-day treatment regimen could be effective in reducing the likelihood of viral rebound. GLP toxicology studies revealed no adverse events in animals at the doses being explored in the Phase 1 trials.

The Phase 1 study involves single and multiple ascending doses of travatrelvir in a double-blinded, placebo-controlled format. Subjects are randomized 3:1 in five fasted and one fed single ascending dosing cohorts, as well as two multiple ascending dosing cohorts. The study is being conducted in Australia, with topline data and the start of an international Phase 2 study in patients with moderate to severe COVID-19 expected in the second half of 2024.

Traws Pharma is focused on developing oral small molecule therapies for respiratory viral diseases and cancer. Its pipeline includes an oral inhibitor of the SARS-CoV-2 Mpro (3CL protease) and a new oral antiviral drug candidate for influenza, which targets the influenza cap-dependent endonuclease and has shown activity against drug-resistant viruses and avian flu in cell-based assays.

In its cancer program, Traws Pharma is advancing narazaciclib, a novel multi-kinase CDK2/4/6 inhibitor, for refractory endometrial cancer and potentially other cancers. This drug targets pathways associated with resistance to existing CDK inhibitors.

Traws Pharma is committed to addressing unmet medical needs through advanced drug development technologies, with a strong emphasis on product safety and patient care. The company aims to tackle significant medical challenges and alleviate the burden of viral infections and cancer.