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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ExeGi Pharma Announces Clearance of Investigational New Drug (IND) Application for EXE-346 a Live Biotherapeutic Biologic Drug","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"ExeGi"}]
Find FDA Investigational New Drug (IND) Submissions for Gastroenterology
EXE-346 is a live biotherapeutic product (LBP) a blend of probiotic bacteria formulated in extremely high potency. The product is currently under development to manage excessive stool frequency in patients who have undergone an ileal pouch-anal anastomosis (IPAA).
The Naval Medical Research Center (NMRC) has executed a research agreement with Immuron to develop and clinically evaluate a new therapeutic CampETEC, targeting Campylobacter and ETEC infections.
Naronapride possess both serotonin 5HT4 receptor agonistic and dopamine D2 receptor antagonistic properties. It is currently being investigaetd for chronic idiopathic constipation (CIC) and gastro-esophageal reflux disease (GERD).
PGN-600 is an orally delivered liquid formulation of tofacitinib for the treatment of ulcerative colitis. Tofacitinib is a Janus Kinase (JAK) inhibitor which causes gut inflammation in ulcerative colitis. Thus, by blocking JAK tofacitinib reduces inflammation.
BEN-8744 is an orally administered, peripherally restricted small molecule PDE10 inhibitor under development as a first-in-class treatment for ulcerative colitis and with the potential for other indications within inflammatory bowel disease.
ALTB-268 is a next-generation PSGL-1 antibody agonist that acts as an immune checkpoint enhancer (ICE) that downregulate chronically activated T-cells by inhibiting the T-cell effector function, promoting T-cell exhaustion and apoptosis.
T21 is a novel potential treatment capable of colon-targeted drug delivery. With a unique 3D dosage form design, T21 can reach the targeted colon segment of the GI tract.
The therapeutic effect of immune checkpoint inhibitors (ICIs), such as antibodies to CTLA-4 and PD-1, might be enhanced by preventing bacterial antigens, toxins, and certain metabolites in the gut from interacting with the host immune system utilizing NM-102.
The study is a randomized, double-blind Phase Ib study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of APL-1401 in patients with moderate to severely active UC.
Pre-clinical studies have indicated that SK10 can reduce the toxicity of chemotherapeutic drugs towards intestinal epithelial cells, regulate the expression of apoptosis-related proteins, reduce inflammatory cytokines, and enhance mucosal barrier function.