Clinical Trials - Phase II
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In a Phase I/II study, Ultragenyx’s antisense oligonucleotide GTX-102 led to significant cognitive, behavioral, sleep and gross motor improvements in patients with the rare genetic disorder Angelman syndrome.
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Arrivo Bio Initiates Large Phase 2b Clinical Trial in Major Depressive Disorder with Novel SIRT6 Activator
4/16/2024
Arrivo Bio announced today a significant step forward in the fight against major depressive disorder (MDD) with the dosing of the first patient in the SP-624-202 clinical trial.
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IGC-AD1’s Interim Phase 2 Data Show a Reduction in Alzheimer’s Agitation at Week Two
4/16/2024
IGC Pharma, Inc. (“IGC Pharma,” “IGC,” or the “Company”) (NYSE American: IGC) today announced that interim data from its Phase 2 clinical trial demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.
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Nascent Prepares for Pivotal Phase II Research with Fresh Manufacturing Run
4/16/2024
Nascent Biotech, Inc. announces that it is embarking on a fresh manufacturing run to ensure Pritumumab supplies are at maximum potency when patient dosing begins in the upcoming Phase II clinical trial.
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St. Michael’s Hospital Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
4/16/2024
Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that a research team from St. Michael’s Hospital, a site of Unity Health Toronto, has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
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Annoviant™ Awarded $2.99 Million NIH Grant to Advance TxGuard™ Pulmonary-Valved Conduit for Pediatric Heart Disease
4/16/2024
Annoviant™, Inc. proudly announces receipt of a $2.99 million grant from the National Institutes of Health.
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PureTech Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis
4/16/2024
PureTech Health plc today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).
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Enlivex Announces Authorization from the Danish Regulatory Agency for the Company’s Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis
4/16/2024
Enlivex Therapeutics Ltd. today announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra TM in up to 160 patients with moderate to severe knee osteoarthritis.
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Nxera Pharma Notes Successful Development Progress of Partnered Schizophrenia Candidate NBI-1117568
4/16/2024
Nxera Pharma Co., Ltd. has been notified by its partner Neurocrine Biosciences Inc. that NBI-1117568, an oral selective muscarinic M4 receptor agonist being advanced in Phase 2 clinical trials by Neurocrine for the treatment of schizophrenia and other neuropsychiatric disorders, has successfully completed a long-term preclinical toxicity program that meets US FDA requirements to allow for safe, chronic dosing in future clinical trials.
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BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
4/16/2024
BioRestorative Therapies, Inc. today announced that the U.S. Food and Drug Administration (“FDA”) has cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company’s lead cell therapy candidate, in treating chronic lumbar disc disease (“cLDD”).
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AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024
4/16/2024
Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20, from 9:15-11:15 a.m. PDT.
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GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.
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Metabolic dysfunction-associated steatohepatitis experts welcomed Madrigal’s Rezdiffra as an “important first," but there are more mid- to late-stage therapies showing promising results.
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Spinogenix Announces U.S. FDA Approval of its Investigational New Drug Application for its Phase 2a Clinical Trial of SPG601 for Fragile X Syndrome
4/15/2024
Spinogenix, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SPG601 for the treatment of people with Fragile X Syndrome (FXS).
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Corcept Completes Enrollment in Phase 2 DAZALS Trial in Patients With Amyotrophic Lateral Sclerosis (ALS)
4/15/2024
Corcept Therapeutics Incorporated today announced completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its proprietary selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS).
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Pulmocide Announces Successful Results from the OPERA-S Study: a Phase 2 Safety Study with Inhaled Opelconazole
4/15/2024
Pulmocide Ltd. today announced topline results from the OPERA-S study: a Phase 2 safety and tolerability study in lung transplant patients receiving inhaled opelconazole monotherapy as prophylaxis against pulmonary aspergillosis.
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TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors
4/15/2024
TransCode Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s Investigational New Drug (IND) application and concluded that the company may proceed with its Phase 1/2 multicenter, open-label, dose-escalation and dose-expansion study of its lead therapeutic candidate.
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TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions
4/15/2024
TFF Pharmaceuticals, Inc. announced additional positive data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder for the prevention of organ rejection in lung transplant recipients.
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Ultragenyx Announces Positive Interim Phase 1/2 Data in Patients with Angelman Syndrome After Treatment with GTX-102
4/15/2024
Ultragenyx Pharmaceutical Inc. announced new data from the Phase 1/2 study of GTX-102 for the treatment of Angelman syndrome.
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Nature Medicine Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of “Off-the-Shelf” Neoantigen Vaccine Platform (SLATE)
4/15/2024
Gritstone bio, Inc., a clinical-stage biotechnology company working to develop the world’s most potent vaccines, announced that a paper detailing the development of its “off-the-shelf” neoantigen platform, SLATE, recently published in Nature Medicine.