The updated data package is expected to be resubmitted to MHRA during the third quarter of 2026. "Based upon recent feedback and further guidance from the MHRA, we believe our updated data package will support the proposed seasonal influenza Challenge study to be conducted in healthy volunteers and provide important proof of concept data for TXM’s use as an oral prophylaxis medicine," commented Iain D. Dukes, MA, DPhil, Chief Executive Officer for Traws Pharma.
Following Traws’ announcement on June 12,.2026, the MHRA provided more detailed feedback that has enabled the Company to prepare additional preclinical safety information for inclusion in the TXM data package. Following the resubmission, the Company expects a formal response from MHRA within 30 days.
"TXM demonstrated broad in vitro efficacy across multiple strains of seasonal influenza and a pharmacokinetic profile consistent with its use as a chemoprophylactic agent," said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. "The Company will also initiate profiling of additional molecules for advancement in its program for influenza treatment."
"Seasonal influenza continues to be a major public health threat in the US and worldwide," commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma. "Influenza treatment and prevention is especially important for vulnerable populations including elderly and immunocompromised individuals who are at much greater risk for severe influenza compared to the general population."
Login to comment