Clinical Trials (Phase I)
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Sitryx announces collaboration partner Lilly has commenced a Phase 1 study of SIT-011 for chronic autoimmune and inflammatory diseases
1/4/2024
Sitryx Therapeutics announces that Eli Lilly & Company has commenced a Phase 1 first-in-human study of SIT-011, a post-translational modification modulator program for chronic autoimmune and inflammatory diseases.
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Patients treated with Longboard Pharmaceuticals’ bexicaserin saw a 32.5% drop in the frequency of countable motor seizures relative to placebo in a Phase 1b/IIa study. The company’s shares soared 316% Tuesday on the news. -
Tango Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of TNG348 in Patients with BRCA1/2-Mutant and Other HRD+ Cancers
1/3/2024
Tango Therapeutics, Inc. announced that the first patient has been dosed in the phase 1/2 trial evaluating TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant or other HRD+ cancers.
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ReCode Therapeutics Doses First Patient in Phase 1 Clinical Study of Novel mRNA-based Therapy for the Treatment of Primary Ciliary Dyskinesia
1/3/2024
ReCode Therapeutics today announced that a patient was treated with RCT1100, a novel mRNA-based therapy currently being evaluated in a Phase 1 study in patients with primary ciliary dyskinesia (PCD) caused by pathogenic mutations in the DNAI1 gene.
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Genascence Announces Initiation of Phase 1b Clinical Trial of GNSC-001 Gene Therapy for Knee Osteoarthritis (OA)
1/3/2024
Genascence Corporation today announced the initiation of its Phase 1b clinical trial of GNSC-001 for the treatment of knee osteoarthritis (OA) (DONATELLO).
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Ultragenyx Announces Completion of Enrollment in Global Phase 1/2 Trial of GTX-102 in Pediatric Patients with Angelman Syndrome
1/3/2024
Ultragenyx Pharmaceutical Inc. today announced the completion of patient enrollment in its Phase 1/2 clinical trial of GTX-102 for the treatment of pediatric patients with Angelman syndrome (AS).
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ChemDiv Marks a Milestone as Orionis Biosciences' Novel Immunotherapy Enters Phase I Clinical Trials
1/3/2024
ChemDiv Inc, a leading provider of drug discovery platforms and development solutions, celebrates a significant milestone in collaboration with Orionis Biosciences: the commencement of Phase I clinical trials for ORB-011, a cutting-edge attenuated, cis-targeted interferon immunotherapy compound.
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Ventus Therapeutics Initiates Clinical Testing of VENT-03, a First-in-Class, Orally Administered cGAS Inhibitor
1/3/2024
Ventus Therapeutics announced today that the first participant has been dosed in a Phase 1 clinical trial of VENT-03, the first cGAS inhibitor to advance into clinical development.
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Investigator-initiated Phase 1/2 Clinical Trial Using Salarius Pharmaceuticals’ Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment
1/3/2024
Salarius Pharmaceuticals, Inc. announces that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center is now listed as active and recruiting on clinical trials.gov – trial NCT04734990.
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MAPLIGHT THERAPEUTICS ANNOUNCES COMPLETION OF PHASE 1 CLINICAL TRIAL FOR NOVEL M1/M4 MUSCARINIC AGONIST IN DEVELOPMENT FOR SCHIZOPHRENIA AND ALZHEIMER'S DISEASE PSYCHOSIS
1/3/2024
MapLight Therapeutics today announced completion of a Phase 1 clinical trial evaluating the bioavailability, safety, and tolerability of an extended release formulation of ML-007, a novel M1/M4 preferring muscarinic agonist, alone and when co-administered with a precision-matched muscarinic antagonist designed to offset peripheral effects.
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OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992
1/3/2024
OBI Pharma, a clinical stage oncology company, announced that the U.S. Food and Drug Administration has cleared an investigational new drug application for OBI-992, to conduct a Phase 1/2 study of its novel antibody - drug conjugate cancer therapy targeting TROP2.
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GPN Vaccines Reports Positive Safety and Immunogenicity Data from its Phase 1 Trial of Gamma-PN
1/3/2024
GPN Vaccines Ltd is pleased to announce positive safety and immunogenicity data from its Phase 1 trial of Gamma-PN, a non-adjuvanted whole cell-pneumococcal vaccine being investigated in adults aged 50 to 69 years.
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Longboard Pharmaceuticals Announces Positive Topline Data from the PACIFIC Study, a Phase 1b/2a Clinical Trial, for Bexicaserin (LP352) in Participants with Developmental and Epileptic Encephalopathies (DEEs)
1/2/2024
Longboard Pharmaceuticals today announced positive topline data from the PACIFIC Study evaluating bexicaserin (LP352), a potentially best-in-class and highly selective, oral, novel 5-HT2C receptor superagonist for seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs).
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Avenue Therapeutics Announces Completion of Enrollment in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)
1/2/2024
Avenue Therapeutics, Inc. today announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy.
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INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune™ in Patients with Metastatic Castration-Resistant Prostate Cancer
1/2/2024
INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023.
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atai Life Sciences Announces Positive Topline Results from Single Ascending Dose Phase 1 Study with EMP-01 (R-MDMA)
1/2/2024
atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced positive results from its Phase 1 study evaluating orally administered EMP-01, the R-enantiomer of MDMA (3,4-methylenedioxy-methamphetamine).
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Regulus Therapeutics Announces Completion of Enrollment in Third Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)
1/2/2024
Regulus Therapeutics Inc. (Nasdaq: RGLS), today announced it has completed enrollment in the third cohort of patients in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD.
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Diakonos Oncology Completes Phase 1 Glioblastoma Trial Recruitment; Receives FDA Orphan Drug Designation
1/2/2024
Diakonos Oncology Corporation, a clinical stage immuno-oncology company, announced it has completed enrollment for its Phase 1 trial of DOC1021, a unique dendritic cell vaccine, for Glioblastoma Multiforme.
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South Rampart Pharma Successfully Completes Phase 1 Study and Expands Phase 2 Plans to Include Neuropathic and Acute Pain Trials
1/2/2024
South Rampart Pharma, Inc. announced today that it has successfully completed a Phase 1 trial (NCT05484414).
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Longboard Pharmaceuticals to Host Call to Discuss Topline Data from the PACIFIC Study, a Phase 1b/2a Clinical Trial for Bexicaserin (LP352) in Participants with Developmental and Epileptic Encephalopathies (DEEs)
1/1/2024
Longboard Pharmaceuticals, Inc. announced that it will host a conference call to discuss topline data from the PACIFIC Study, a Phase 1b/2a clinical trial evaluating bexicaserin in participants with a broad range of Developmental and Epileptic Encephalopathies.