Enveda has obtained IND clearance from the FDA and initiated a phase I trial of ENV-6946, a first-in-class oral small molecule for the treatment of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.
Growth factor specialist Agomab Therapeutics NV is now preparing to move into phase IIb development after delivering positive phase IIa results for its lead program, ontunisertib, an orally available treatment for fibrostenosing Crohn’s disease.
Imhotex Ltd. has disclosed desmuramylpeptide (DMP) analogues of muramyl dipeptide (MDP) acting as nucleotide-binding oligomerization domain-containing protein 2 (NOD2) activators reported to be useful for the treatment of Crohn’s disease.
NOD2 deficiency is involved in the pathogenesis of Crohn’s disease (CD) due to failure of gut innate immunity and loss of intestinal tissue homeostasis. Orchard Therapeutics Ltd. has presented preclinical data on OTL-104, human hematopoietic stem cell (HSC) gene therapy for the treatment of NOD2-deficient CD.
A new study aimed to investigate the therapeutic effect of ISM012-042 in a chronic T-cell transfer-induced colitis model in mice that mimicked Crohn’s disease.
Haisco Pharmaceutical Group Co. Ltd. has identified pyridone derivatives acting as integrin α4β7 (LPAM-1) antagonists reported to be useful for the treatment of Crohn’s disease and ulcerative colitis.
Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
As Wall Street awaits key phase III data from Abivax SA with microRNA-124 (miR-124)-targeting obefazimod in ulcerative colitis, due this quarter, the inflammatory bowel disease (IBD) space – which also takes in Crohn’s disease – continues to grow and shift with new findings across varied fronts.
