(RTTNews) - Traws Pharma Inc. (TRAW) has announced the completion of enrollment in its ongoing Phase 2 study comparing Ratutrelvir with PAXLOVID in patients with mild to moderate COVID-19, as well as in a single arm in PAXLOVID-ineligible subjects.
In addition, the company provided an update on the expansion of the tivoxavir marboxil (TMX) program for seasonal influenza, as well as for bird flu.
Ratutrelvir is an investigational oral, small-molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir.
Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) is an approved drug for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
The Phase 2 study of Ratutrelvir is a 90-patient, open-label, active-controlled, comparator trial versus PAXLOVID evaluating patient-reported symptom outcomes, safety, and real-world usability. A separate treatment arm was comprised of patients ineligible for ritonavir-boosted regimens due to contraindications and potential drug interactions.
Patients in the Ratutrelvir arm received Ratutrelvir 600 mg orally once daily for 10 days, while patients in the comparator arm received oral PAXLOVID, consisting of nirmatrelvir 300 mg twice daily plus ritonavir 100 mg twice daily for 5 days, as per approved prescribing information.
Ratutrelvir-based preclinical and Phase 1 studies demonstrated that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, thus avoiding ritonavir-associated drug-drug interactions, and potentially enabling wider patient use. Also, in the phase 1 trial, results show that Ratutrelvir maintains target blood plasma levels about 13 times above the EC50 (half maximal effective concentration) when given at the planned Phase 2 dose of 600 mg per day for 10 days. This sustained drug exposure may lower the risk of viral rebound and potentially reduce the likelihood of Long COVID.
"From a clinical perspective, the ongoing data analysis confirms previous reports that Ratutrelvir may provide a meaningful benefit across a broader range of patients, including those who are unable to receive ritonavir-boosted therapy," commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma.
Tivoxavir Marboxil (TXM)
Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single dose for the treatment of bird flu and is being expanded for the treatment or prophylaxis of seasonal influenza.
According to the company, TXM has demonstrated strong in vitro activity in preclinical studies against a range of influenza strains, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu).
As per Grand View Research, the global influenza vaccine market size was estimated at USD 7.91 billion in 2023 and is projected to reach USD 12.58 billion by 2030, growing at a CAGR of 6.9% from 2024 to 2030.
TXM in prior Phase 1 studies in healthy volunteers, as an unformulated powder-in-capsule formulation, provided blood levels exceeding 3X the EC50 against a basket of common seasonal influenza variants for up to 22 days after drug administration, commented David Pauza, PhD, Chief Science Officer of Traws Pharma.
He added that a new compressed tivoxavir marboxil may provide 28-day coverage, enabling a once-a-month prophylactic treatment.
Once a planned bridging healthy volunteer study has confirmed the extended exposure, Traws Pharma plans to progress TXM into a human influenza prophylaxis challenge study, with a time slot secured for June 2026 at hVIVO, a Contract Research Organisation (CRO) for such studies.
Over the year, TRAW has traded in a range of $0.970 to $8.61. The stock closed Monday's trade at $2.79, up 15.29%.
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