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Expert Systems Inc., a leading life sciences accelerator, announced its continued support for Traws Pharma (NASDAQ: TRAW) as the company initiates Phase 2 clinical studies of Ratutrelvir (TRX01), a next-generation oral antiviral designed to treat newly diagnosed COVID-19 patients.
Expert Systems' predictive pharmacology and AI-driven molecular modeling played a central role in Ratutrelvir's differentiation—optimizing pharmacokinetics, safety, and potency profiles to ensure broad clinical applicability across both therapeutic and preventive settings.
Ratutrelvir (TRX01) demonstrates broad-spectrum in vitro activity against a range of SARS-CoV-2 virus strains and maintains exceptional potency profiles without requiring ritonavir co-administration. Its ritonavir-independent formulation eliminates the need for metabolic boosting, avoiding the ritonavir-associated drug-drug interactions that currently exclude approximately 20% of COVID patients from protease inhibitor treatment.
In Phase 1 multiple ascending dose (MAD) studies, a daily oral 600 mg regimen sustained plasma concentrations ~13Ă— above EC50 for the full 10-day course, with trough levels remaining above EC90Â - critical for preventing viral rebound. Expert Systems' modeling predicts even higher concentrations in lung tissue versus plasma, enhancing antiviral exposure at the primary infection site..
Following successful completion of Phase 1 safety and PK studies, regulatory approval was granted for Phase 2 initiation in Q3 2025. The Phase 2 program includes:
- A non-inferiority trial versus PAXLOVID® in newly diagnosed COVID-19 patients; and
- A single-arm trial in PAXLOVID®-ineligible populations—an underserved group at greater risk for severe outcomes.
"COVID-19 continues to pose a significant public health threat, particularly among elderly and immunocompromised individuals who often cannot access current standard-of-care options," said Dr. Tudor Oprea, CEO of Expert Systems Inc. "By applying our AI/ML-driven molecular design platform to systematically optimize both potency and pharmacokinetics without ritonavir, we enabled the development of a truly differentiated antiviral. Ratutrelvir's superior 13Ă— EC50, ritonavir-free exposure, for an extended 10-day regimen, and excellent safety profile collectively exemplify precision drug design, targeting not only active infection but also the prevention of viral rebound and Long COVID."
Expert Systems will continue to provide strategic, scientific, and technological support as Ratutrelvir advances through human efficacy studies. This collaboration underscores Expert Systems' capability to apply computational design and predictive pharmacology to de-risk innovation and accelerate clinical translation of best-in-class therapeutics.
About Expert Systems Inc.
Expert Systems Inc. is a life sciences accelerator advancing the next generation of precision therapeutics. Its AI/ML-enabled platform integrates rational drug design, predictive pharmacology, translational modeling, regulatory strategy, and partnering support across the biotech value chain.
With a proven record of creating and scaling multiple Seed and Series A ventures, Expert Systems has supported more than 30 R&D programs funded by institutional investors and strategic partners across North America, Europe, and Australia. By shortening timelines from in silico discovery to first-in-human trials, Expert Systems transforms high-potential science into investable, clinically ready opportunities.
Media Contact:
Bill Farley, CBO
Expert Systems Inc.
bfarley@expertsystems.incÂ
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SOURCE Expert Systems, Inc.
