Traws Pharma Reports Positive Interim Clinical Data with Ratutrelvir Versus PAXLOVID™, Shows Activity in PAXLOVID-Ineligible COVID-19 Patients

Core Viewpoint - Ratutrelvir demonstrates a differentiated clinical profile compared to PAXLOVID™, showing fewer adverse events and no viral rebounds, making it a promising treatment option for patients with mild-to-moderate COVID-19, including those ineligible for ritonavir-boosted therapies [1][5][12]. Group 1: Clinical Study Overview - Traws Pharma announced interim data from a Phase 2 clinical study of ratutrelvir, an oral, ritonavir-free protease inhibitor, which showed a favorable clinical profile in patients with mild-to-moderate COVID-19 [2][3]. - The study is an active-controlled trial comparing ratutrelvir to PAXLOVID™, with 37 patients included in the interim analysis, of which 25 received ratutrelvir and 12 received PAXLOVID™ [3][4]. - More than 50% of the planned 90-patient population has been enrolled in the study [3]. Group 2: Efficacy and Safety - Ratutrelvir-treated patients showed comparable time-to-sustained symptom alleviation to those treated with PAXLOVID™, with sustained alleviation defined as self-reported alleviation of all COVID-19 symptoms for four consecutive days [6]. - No COVID-19 symptom or virologic rebound events were observed in ratutrelvir-treated patients, while one rebound event occurred in the PAXLOVID™ group [7]. - Ratutrelvir was well tolerated, with fewer adverse events reported compared to the PAXLOVID™ cohort, where 30% of patients experienced adverse events [9][10]. Group 3: Implications for Long-COVID - The combination of early and sustained symptom improvement, absence of viral rebound, and favorable tolerability suggests that ratutrelvir may be useful in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID) [12]. - Ratutrelvir's design allows for broader patient use without the limitations associated with ritonavir, potentially offering a new approach to both acute COVID-19 treatment and prevention of long-term complications [12][13]. Group 4: Market Potential - The COVID treatment market represents a potential multi-billion dollar opportunity, with ratutrelvir positioned as a next-generation oral 3CL protease inhibitor that is ritonavir-free and has an improved tolerability profile [14].