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2022","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Anokion SA"},{"orgOrder":0,"company":"Surrozen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Surrozen Presents Data on Lead Therapeutic Candidates at Digestive Disease Week (DDW)","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Surrozen"},{"orgOrder":0,"company":"D. E. Shaw Research","sponsor":"Eli Lilly","pharmaFlowCategory":"D","amount":"$535.0 million","upfrontCash":"$60.0 million","newsHeadline":"D. E. Shaw Research Licenses First-in-Class Therapeutic for Immunological Diseases to Lilly","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"D. E. Shaw Research"},{"orgOrder":0,"company":"AgomAb Therapeutics N.V","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"$114.0 million","upfrontCash":"Undisclosed","newsHeadline":"Agomab Raises Additional $40.5 Million Through Series B Extension Bringing Total Amount to $114 Million","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AgomAb Therapeutics N.V"},{"orgOrder":0,"company":"Landos Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Landos Biopharma Reports Positive Top-Line Results From NX-13 Phase 1b Trial","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Landos Biopharma"},{"orgOrder":0,"company":"BiomX","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BiomX Announces Publication in Cell of Research Demonstrating Proof-of-Concept Assessment of Orally Administered Phage Treatment in Preclinical Model of Inflammatory Bowel Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"BiomX"},{"orgOrder":0,"company":"Immunic Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Immunic Receives Notice of Allowance for Composition-of-Matter Patent in the United States for IMU-856, a Small Molecule Modulator Targeting Restoration of Intestinal Barrier Function and Regeneration of Bowel Epithelium","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Immunic Therapeutics"},{"orgOrder":0,"company":"Immunic Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Immunic Announces Positive Results from Single and Multiple Ascending Dose Parts of Its Phase 1 Clinical Trial of IMU-856 in Healthy Human Subjects","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Immunic Therapeutics"},{"orgOrder":0,"company":"Equillium","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Equillium Announces Initiation of Phase 1 Study of EQ102, A First-in-Class Multi-Cytokine Inhibitor of IL-15 and IL-21 Targeting Celiac Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Equillium"},{"orgOrder":0,"company":"Federation Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Federation Bio Administers First Dose in Phase 1 Clinical Trial Evaluating Investigational Bacterial Cell Therapy","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Federation Bio"},{"orgOrder":0,"company":"Landos Biopharma","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$16.7 million","upfrontCash":"Undisclosed","newsHeadline":"Landos Biopharma Announces $16.7 Million Private Placement Financing","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Landos Biopharma"},{"orgOrder":0,"company":"Suono Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Suono Bio, Inc. Announces First Patient Dosed with its SuonoCalmTM Platform","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Suono Bio"},{"orgOrder":0,"company":"Cellf BIO","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cellf BIO Begins Phase 1 Clinical Trial of BioSphincter Implant for Fecal Incontinence","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Cellf BIO"},{"orgOrder":0,"company":"Landos Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Landos Biopharma Announces Acceptance of Abstract on NX-13 Phase 1b Study in Ulcerative Colitis at 18th Annual Congress of the European Crohn's and Colitis Organization","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Landos Biopharma"},{"orgOrder":0,"company":"AltruBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AltruBio Announces First Patient Dosed in Phase 1 Trial of Next-Generation Immune Checkpoint Enhancer ALTB-268 for the Treatment of Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"AltruBio"},{"orgOrder":0,"company":"Jaguar Health","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jaguar Health Provides Updates Regarding Company's Focus on Rare and Orphan Disease Indications in the U.S. & Europe","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Jaguar Health"},{"orgOrder":0,"company":"Napo Therapeutics","sponsor":"SPRIM Global Investments","pharmaFlowCategory":"D","amount":"$58.8 million","upfrontCash":"Undisclosed","newsHeadline":"Jaguar Health Announces Initial Close in Private Placement Financing Round for Napo Therapeutics S.p.A.","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Napo Therapeutics"},{"orgOrder":0,"company":"AgomAb Therapeutics N.V","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Agomab Reports Positive Phase 1 Results with AGMB-129, a GI-restricted ALK5 Inhibitor for Fibrostenosing Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AgomAb Therapeutics N.V"},{"orgOrder":0,"company":"Enthera Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Enthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Enthera Pharmaceuticals"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Announces Initiation of Phase 1 Clinical Trial for Medically Refractory Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Direct Biologics"}]
Find Gastroenterology Drugs in Phase I Clinical Development
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Quotient has prior experience of working with the Nuformix NXP-001 co-crystal and previously developed a capsule and a powder for oral suspension formulation of Aprepitant, evaluating its performance in a relative bioavailability study versus EMEND.
Lead Product(s):
Aprepitant
Therapeutic Area: Gastroenterology Product Name: NXP-001
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator:
Oxilio
Deal Size: UndisclosedUpfront Cash: Undisclosed
Deal Type: AgreementFebruary 07, 2022
Details:
DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.
Lead Product(s):
ExoFlo
Therapeutic Area: Gastroenterology Product Name: DB-001
Highest Development Status: Phase I Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableMarch 21, 2023
Details:
Ent001 targets the TMEM219 ligand, IGFBP3, it is designed to bind to TMEM219 and prevent cell death and the inflammation in type 1 diabetes and several other autoimmune diseases.
Lead Product(s):
Ent001
Therapeutic Area: Gastroenterology Product Name: Ent001
Highest Development Status: Phase I Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableMarch 07, 2023
Details:
The company's initial focus is on clinical development and future registration in Europe of Mytesi (crofelemer) for two debilitating rare disease target indications: short bowel syndrome (SBS) and congenital diarrheal disorders (CDD) with intestinal failure.
Lead Product(s):
Crofelemer
Therapeutic Area: Gastroenterology Product Name: Mytesi
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator:
SPRIM Global Investments
Deal Size: $58.8 millionUpfront Cash: Undisclosed
Deal Type: Private PlacementFebruary 09, 2023
Details:
AGMB-129 (ORG-129) is an oral, small molecule GI-restricted inhibitor of ALK-5 (or TGFbR1) for the treatment of Fibrostenosing Crohn’s Disease. TGFb is a known master regulator of fibrosis and preliminary clinical data supports targeting the pathway in fibrotic indications.
Lead Product(s):
ORG-129
Therapeutic Area: Gastroenterology Product Name: AGMB-129
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableFebruary 02, 2023
Details:
Mytesi (crofelemer) is an inhibits both cAMP-stimulated CFTR chloride ion channel, and the CaCC at the luminal membrane of enterocytes. Drug blocks Cl¯ secretion and accompanying high volume water loss in diarrhea, normalizing Cl¯ flow and water in the gastrointestinal tract.
Lead Product(s):
Crofelemer
Therapeutic Area: Gastroenterology Product Name: Mytesi
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJanuary 26, 2023
Details:
ALTB-268 is a next-generation PSGL-1 antibody agonist that acts as an immune checkpoint enhancer (ICE) that downregulates chronically activated T-cells by inhibiting the T-cell effector function, promoting T-cell exhaustion and apoptosis.
Lead Product(s):
ALTB-268
Therapeutic Area: Gastroenterology Product Name: ALTB-268
Highest Development Status: Phase I Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJanuary 23, 2023
Details:
NX-13 is a first-in-class novel, gut-selective oral therapeutic candidate that targets NLRX1 that has been associated with the modulation of inflammatory cytokines for UC and CD.
Lead Product(s):
NX-13
Therapeutic Area: Gastroenterology Product Name: NX-13
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJanuary 11, 2023
Details:
Landos Biopharma anticipates using the net proceeds from the investment to advance the development of NX-13 for Ulcerative Colitis and Crohn’s Disease and for other general corporate purposes.
Lead Product(s):
NX-13
Therapeutic Area: Gastroenterology Product Name: NX-13
Highest Development Status: Phase I Product Type: Small molecule
Partner/Sponsor/Collaborator:
Undisclosed
Deal Size: $16.7 millionUpfront Cash: Undisclosed
Deal Type: Private PlacementJanuary 05, 2023
Details:
The trial will assess the safety of the treatment and the potential initial efficacy of the BioSphincter (Autologous Bioengineered Internal Anal Sphincter) in reducing the number of incontinence episodes in patients with severe fecal incontinence.
Lead Product(s):
Autologous Bioengineered Internal Anal Sphincter
Therapeutic Area: Gastroenterology Product Name: BioSphincter
Highest Development Status: Phase I Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJanuary 05, 2023
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