Microbiome therapeutics company Seres Therapeutics Inc (NASDAQ: MCRB) announced on Tuesday that it has finished patient enrollment for the Phase 1B trial of SER-155 in Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT) patients.
SER-155 aims to reduce enteric-derived infections and bloodstream infections, including those with antibiotic resistance, in immunocompromised patients. Enrollment for the placebo-controlled Cohort 2 is now complete.
The Phase 1B trial is conducted across 13 clinical centres in the US, including Memorial Sloan Kettering, with Cohort 1 demonstrating favorable tolerability and successful drug bacteria engraftment.
SER-155 utilises Seres' reverse translation discovery platform and has received FDA Fast Track Designation. It is designed to prevent bacterial pathogen colonization and enhance GI tract integrity, potentially reducing infections and GvHD incidence.
Seres Therapeutics' lead program VOWST is approved by the FDA for preventing recurrence of C. difficile infection.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA