Clinical Trials (Phase II)
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Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease. -
Spago Nanomedical has Submitted Application to Start Tumorad(R) Clinical Phase I/IIa Study
5/23/2023
Spago Nanomedical AB announced that the final step in the preparations for the clinical phase I/IIa trial in cancer patients, Tumorad-01, with its leading candidate drug 177Lu-SN201 has begun in Australia.
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AnaMar Announces Positive Phase I Data for its Phase II Ready Compound AM1476 for Treating Fibrosis
5/23/2023
AnaMar, a clinical-stage biotech company developing a first-in-class, peripheral 5-HT2B receptor antagonist, AM1476, as a pan anti-fibrotic medicine, announces positive results from its Phase I study, and the completion of Phase II enabling pre-clinical studies for its initial orphan indication in systemic sclerosis characterized by lung and skin fibrosis.
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The 61-patient study met the primary endpoint of improved physiologic liver function and secondary endpoints, which included established non-alcoholic steatohepatitis biomarkers, Hepion reported Monday. -
ABVC BioPharma Vitargus® Phase II Study Received Ethical Approval at Sydney Eye Hospital in Australia
5/22/2023
ABVC BioPharma, Inc. today announced that the Vitrargus® Phase II study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) on May 15, 2023.
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Clearmind Medicine Announces First US Site for its Phase I/IIa Clinical Trial Evaluating CMND-100 in Patients with Alcohol Use Disorder
5/22/2023
Clearmind Medicine Inc. today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder ("AUD").
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Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer
5/22/2023
Panbela Therapeutics, Inc. today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC).
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Trevi Therapeutics Announces Publication of Positive Data from the CANAL Trial in IPF Chronic Cough in NEJM Evidence
5/22/2023
Trevi Therapeutics, Inc. (Nasdaq: TRVI) today announced the positive results from the Phase 2 CANAL trial in adults with IPF chronic cough has been published in NEJM Evidence.
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FDA Authorizes Phase II Study for Natrunix in Rheumatoid Arthritis PatientsXBiotech Believes its Drug Candidate Natrunix Could Revolutionize Arthritis Treatment
5/22/2023
XBiotech Inc. (NASDAQ: XBIT) today reports that the FDA’s Division of Rheumatology has authorized the Company to initiate a Phase II clinical study to test Natrunix™ as a treatment for Rheumatoid Arthritis.
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Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces the Rate of Lung Function Decline in Patients with Idiopathic Pulmonary Fibrosis
5/22/2023
Bristol Myers Squibb (NYSE: BMY) today announced results from a Phase 2 study evaluating BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis.
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Valbiotis Announces the Large Success of the REVERSE-IT International Multicentric Phase II/III Clinical Study on TOTUM•63: Proven Efficacy on the Main Risk Factor of Developing Type 2 Diabetes
5/22/2023
Valbiotis (FR0013254851 – ALVAL, PEA/PME eligible) (Paris:ALVAL), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces the large success of the REVERSE-IT Phase II/III clinical study on TOTUM•63.
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BridgeBio Pharma Presents Updated Encouraging Clinical and Biomarker Data from its BBP-812 Canavan Disease Gene Therapy Program at the 2023 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting
5/22/2023
BridgeBio Pharma, Inc. presented promising positive data from six participants dosed in CANaspire, its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease.
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Hepion Pharmaceuticals’ Phase 2 ‘ALTITUDE-NASH’ Trial Achieves Primary and Secondary Endpoints, Including Improvement in Liver Function and Multiple NASH Biomarkers
5/22/2023
Hepion Pharmaceuticals, Inc. today announced positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial.
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IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors
5/22/2023
IDEAYA Biosciences, Inc. announced that the U.S. Food and Drug Administration has completed its review of the Amgen-sponsored Investigational New Drug application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion.
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Axalbion Presented Promising Phase 2 Clinical Data in Chronic Cough with AX-8, a Novel TRPM8 Agonist, in an Oral Presentation at the American Thoracic Society (ATS) 2023 International Conference
5/22/2023
Axalbion presented positive results from a Phase 2 proof-of-concept study with its transient receptor potential melastatin 8 (TRPM8) agonist, AX-8, in patients with refractory or unexplained chronic cough, in an oral session at the American Thoracic Society (ATS) 2023 International Conference, being held in Washington, DC, from May 19 - 24, 2023.
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Apnimed Presented Positive Phase 2b Results on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea, for the First Time at ATS 2023
5/21/2023
Apnimed presented positive results from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study of AD109 over a one-month duration, for the first time in the Breaking News in OSA Mini Symposium at the ATS 2023 International Conference in Washington, DC.
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Nexcella Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial
5/21/2023
Nexcella, Inc. announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis.
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Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial
5/21/2023
Immix Biopharma, Inc., announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis.
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Hepion Pharmaceuticals Schedules Conference Call to Review Topline Results from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat
5/19/2023
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) today announced that it expects to release topline results from the Phase 2 ALTITUDE-NASH clinical trial before the market opens on Monday, May 22, 2023.
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Positive Results from Interim Analysis of 'GEN-001' Plus avelumab (Bavencio®) Phase II Trial
5/19/2023
Genome & Company (CEOs: Pae, Jisoo, Park, Hansoo), a global leading microbiome therapeutics developer, announced that this phase II trial (NCT05419362) will continue without modifications to move on to the second stage, based on the positive result of the interim analysis.