Clinical Trials (Phase II)
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In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.
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BridgeBio Pharma Announces First Lung Cancer Patient Dosed in Phase 1 Trial for SHP2 Inhibitor BBP-398 in Combination with Bristol Myers Squibb’s OPDIVO® (nivolumab)
3/23/2023
BridgeBio Pharma, Inc. today announced that the first patient with non-small cell lung cancer (NSCLC) has been dosed in its Phase 1/2 clinical trial of BBP-398, an investigational SHP2 inhibitor, with Bristol Myers Squibb’s OPDIVO® (nivolumab) in advanced solid tumors with KRAS mutations (NCT05375084)
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AbbVie Advances Upadacitinib (RINVOQ®) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus
3/23/2023
AbbVie (NYSE: ABBV) today announced topline results from a Phase 2 study of upadacitinib (RINVOQ®, 30 mg) given alone or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once daily in patients with moderately to severely active systemic lupus erythematosus (SLE).
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Immutep Announces Abstract Accepted for Mini Oral Presentation at ESMO’s European Lung Cancer Congress 2023
3/23/2023
Immutep Limited today announces that new data evaluating eftilagimod alpha in combination with pembrolizumab from Part B of the TACTI-002 Phase II trial in 2nd line PD-X refractory non-small cell lung cancer (NSCLC) patients has been accepted for a Mini Oral presentation at ESMO’s European Lung Cancer Congress (ELCC) 2023 taking place in Copenhagen, Denmark and virtually from 29 March to 1 April 2023.
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IMUNON to Hold Fourth Quarter 2022 Financial Results and Business Update Conference Call on Thursday, March 30, 2023
3/23/2023
IMUNON, Inc. announces that the Company will host a conference call at 11:00 a.m. ET on Thursday, March 30, 2023 to discuss financial results for the fourth quarter and full year ended December 31, 2022 and provide an update on its clinical development of IMNN-001.
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Biomea Fusion to Host Conference Call and Webcast to Discuss Initial Phase II Clinical Data for BMF-219 in Subjects with Type 2 Diabetes on March 28th, 2023 at 8:30 a.m. ET
3/23/2023
Biomea Fusion, Inc. today announced that it will host a conference call and webcast to discuss the initial clinical data from the first two cohorts of the Phase II portion of COVALENT-111 on Tuesday, March 28th at 8:30 am ET.
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Eledon to Present Data from Ongoing Phase 1b Trial Evaluating Tegoprubart in Kidney Transplantation at the World Congress of Nephrology 2023
3/23/2023
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the Company will present two posters at the upcoming International Society of Nephrology’s World Congress of Nephrology (WCN) 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023.
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Data from the Phase IIb ENLIVEN trial showed 89bio’s pegozafermin met its primary histology endpoint in NASH patients, giving the company an edge in the competitive space.
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Mayank Mamtani, managing director and group head of healthcare research at B. Riley Securities, told BioSpace he believes Altimmune's pemvidutide still shows promise despite safety concerns.
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Alzamend Neuro Announces Completion of Clinical Portion of Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
3/22/2023
Alzamend Neuro, Inc. today announced the completion of the clinical portion of its Phase IIA multiple ascending dose (“ MAD ”) study for dementia related to Alzheimer’s.
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DermBiont Presents Positive Phase 2 Trial Data Treating Seborrheic Keratosis with SM-020 Topical Gel at American Academy of Dermatology Annual Meeting
3/22/2023
DermBiont today announced that its Phase 2 adaptive design trial with of investigational drug SM-020 gel 1.0% met its primary endpoint of a one point improvement in Physician’s lesion assessment (PLA) score at last visit and safety via local tolerability, as well as key multiple secondary endpoints including complete clearance of treated lesions.
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Moleculin Announces Interim Phase 2 Data in STS Clinical Trial and Update on Recruiting, Preliminary Efficacy and Expected Milestones for AML Clinical Trials
3/22/2023
Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company) today announced recent activity, new positive data and expected near term milestones across its clinical development pipeline.
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Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal MetastasesFirst data readout of Phase 1/Part A trial expected second half of 2023
3/22/2023
Plus Therapeutics, Inc. today announced treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium ( 186 Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.
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89bio’s Phase 2b ENLIVEN Trial of Pegozafermin in Nonalcoholic Steatohepatitis (NASH) Achieved High Statistical Significance on Both Primary Histology Endpoints with Weekly (QW) and Every-Two-Week (Q2W) Dosing at 24 Weeks
3/22/2023
89bio, Inc. today announced positive topline data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
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DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCi™ STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM
3/22/2023
Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases, today announced the first patient dosed of their first-in-human, phase 1/2 study, GaLuCi™.
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Alzheon to Present Biomarker, Brain Preservation and Clinical Effects of Oral Tablet ALZ-801 (Valiltramiprosate) at Upcoming AD/PD 2023 Conference in Gothenburg, Sweden
3/22/2023
Alzheon, Inc. announced that it will be presenting interim findings from an ongoing Phase 2 study evaluating ALZ-801 tablet at the upcoming AD/PD 2023 Conference to be held from March 28 – April 1, 2023 in Gothenburg, Sweden.
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Disc Medicine Announces Collaboration with National Institutes of Health for Phase 2 Clinical Study of Bitopertin in Patients with Diamond-Blackfan Anemia (DBA)
3/21/2023
Disc Medicine, Inc. announced a collaboration with the National Heart Lung and Blood Institute of the National Institutes of Health to evaluate bitopertin, a therapeutic candidate designed to modulate heme biosynthesis, in a phase 2 clinical study of patients with Diamond-Blackfan anemia.
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Altimmune Announces Positive Results from Week 24 Interim Analysis of Pemvidutide MOMENTUM Phase 2 Obesity Trial and 12-Week Phase 1b Type 2 Diabetes Safety Trial
3/21/2023
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the “Company”), today announced topline results from a Week 24 interim analysis of 160 subjects in its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide along with the results of the 12-week Phase 1b safety trial of pemvidutide in subjects with obesity or overweight and type 2 diabetes.
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Axalbion to Present 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
3/21/2023
Axalbion announced that it will present 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.
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Proxima Clinical Research Launches Early Phase Oncology Network for New Investigational Therapies
3/21/2023
Proxima Clinical Research ("Proxima CRO") announced today it is expanding its early phase oncology clinical trials offering with its Early Phase Oncology Network, a group of oncology-specific scientific experts and early phase clinical trials clinics that allows for quick and easy site enrollment and expert insight, feedback, and guidance in first-in-human Phase I and Phase II clinical oncology trials.