ChemDiv Extends CMC Collaboration for Ratutrelvir, an Oral COVID-19 Antiviral Advancing to Phase 2
ChemDiv Inc., a global provider of integrated drug discovery solutions, announced the extension of its Chemistry, Manufacturing and Controls (CMC) services collaboration supporting the clinical development of ratutrelvir, an oral antiviral candidate for COVID-19.
The announcement follows progress by Traws Pharma, Inc. (NASDAQ: TRAW), which dosed the first patient in Phase 2 studies of ratutrelvir in October 2025, with top-line results expected by year-end.
Discovery and Differentiation
Ratutrelvir — a ritonavir-free Main protease (Mpro/3CL) inhibitor — was discovered and developed ab initio by ChemDiv’s medicinal chemistry and virology teams. Using Molsoft’s rational drug design platform and Expert Systems’ predictive pharmacology tools, the program advanced from target to clinic under ChemDiv’s integrated discovery model.
Designed to address limitations of existing COVID-19 antivirals, ratutrelvir aims to provide:
- High potency across native and resistant SARS-CoV-2 strains
- A simplified 10-day oral regimen
- No ritonavir co-administration, potentially reducing drug–drug interactions
Expanded Collaboration Scope
ChemDiv’s extended support to Traws Pharma includes:
- CMC process research and scale-up for API and drug product manufacturing supporting non-GLP and GLP studies
- Medicinal chemistry for backup series development
- Translational pharmacology through computational modeling and wet-lab validation
- Clinical pharmacology consulting to optimize dosing for Phase 2 and beyond
“We’re proud to support the advancement of ratutrelvir from discovery through clinical development,” said Ilya Baimetov, Chief Operating Officer, ChemDiv. “By combining our integrated chemistry capabilities with Molsoft’s design tools and Expert Systems’ AI-driven pharmacology, we’ve created a differentiated COVID therapeutic with best-in-class potential. Our continued CMC support ensures Traws has the manufacturing and analytical readiness for clinical success.”
AI-Enabled Predictive Safety Program
Expert Systems, which collaborated on the compound’s discovery, has extended its partnership with Traws Pharma to provide predictive safety pharmacology through its AI-enabled drug discovery platform. The program is designed to de-risk clinical progression and accelerate regulatory readiness.
Phase 2 Clinical Development
Ratutrelvir is currently being tested in two Phase 2 clinical studies:
- A non-inferiority trial comparing ratutrelvir with PAXLOVID® in newly diagnosed COVID-19 patients.
- A single-arm trial in PAXLOVID®-ineligible patients, addressing an underserved population with limited treatment options.
Phase 1 results indicated that ratutrelvir maintained plasma concentrations 13 times above the EC₅₀ with once-daily dosing for 10 days, without ritonavir co-administration — potentially lowering the risk of viral rebound and Long COVID.
About Ratutrelvir
Ratutrelvir is an investigational oral Mpro (3CL protease) inhibitor under development for the treatment of COVID-19. Preclinical and Phase 1 data have demonstrated broad-spectrum activity against nirmatrelvir-resistant variants and a favorable pharmacokinetic profile. It is currently in Phase 2 clinical development by Traws Pharma.
About Expert Systems
Expert Systems Inc. operates an AI-driven drug discovery accelerator spanning target identification, virtual screening, pharmacology, toxicology, and chemical liability assessment. Its hybrid predictive platform supports early drug discovery and translational development.
About Traws Pharma
Traws Pharma (NASDAQ: TRAW) is a clinical-stage biopharmaceutical company focused on developing oral antiviral therapies for respiratory viral diseases, including ratutrelvir for COVID-19 and tivoxavir marboxil for influenza.
About ChemDiv
ChemDiv is a global discovery partner offering end-to-end solutions from target to clinic. The company’s portfolio includes a 12-million-compound screening library, AI-powered computational drug design, and integrated CMC and clinical pharmacology services supporting pharmaceutical and biotech innovators worldwide.
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