Clinical Trials - Phase I
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The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances. -
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
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Kiromic BioPharma Announces FDA Authorization of IND to Initiate Phase 1 Clinical Trial Evaluating Deltacel in Non-Small Cell Lung Cancer
5/1/2023
Kiromic BioPharma, Inc. today announces that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate Deltacel (KB-GDT-01) for patients with non-small cell lung cancer (NSCLC).
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Elicio Therapeutics to Present Interim Data from the Ongoing Phase 1 Study of Investigational Therapeutic Cancer Vaccine, ELI-002, in Patients with High Relapse Risk Pancreatic and Colorectal Cancer at ASCO
5/1/2023
Elicio Therapeutics announced that interim data from the Phase 1 study of its lead asset, ELI-002, will be presented in a poster discussion presentation at the upcoming 2023 American Society of Clinical Oncology Annual Meeting, a hybrid event taking place online and at McCormick Place in Chicago from June 2-6, 2023.
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Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia
5/1/2023
Biomea Fusion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to begin a Phase I trial (COVALENT-103) of BMF-500.
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Atsena Therapeutics Receives FDA Clearance of IND Application for ATSN-201, an Investigational Gene Therapy for the Treatment of X-linked Retinoschisis
5/1/2023
Atsena Therapeutics today announced the U.S. ood and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for a Phase I/II clinical trial of ATSN-201 in patients with X-linked retinoschisis (XLRS).
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Protara Therapeutics Announces Positive Preliminary Data from ADVANCED-1 Phase 1a Dose Escalation Trial of TARA-002 in NMIBC Supporting Advancement into Phase 2 Clinical Development
4/28/2023
Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced positive preliminary results from the Phase 1a dose-escalation component of its ongoing ADVANCED-1 clinical trial of TARA-002, the Company’s investigational cell-based therapy, for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC).
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Tempest Announces Positive Early Results from Global Randomized Phase 1b/2 Combination Study of TPST-1120 in First-Line Hepatocellular Carcinoma
4/28/2023
Tempest Therapeutics, Inc. today announced positive early results from a global randomized Phase 1b/2 clinical study in which TPST-1120, Tempest’s small molecule PPAR⍺ antagonist, demonstrated clinically-meaningful improvement in multiple categories when combined with the standard-of-care regimen of atezolizumab and bevacizumab in a randomized comparison to atezolizumab and bevacizumab in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC).
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IMG-004 demonstrated extended half-life and durable pharmacodynamic characteristics in a Phase 1 study
4/28/2023
Inmagene Biopharmaceuticals announced positive topline results from a Phase 1 study evaluating IMG-004 in healthy participants.
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Elicio Therapeutics Announces First Patient Dosed in Phase 1/2 Study of Lymph Node-Targeted Investigational Therapeutic Vaccine ELI-002 7P (AMPLIFY-7P) in KRAS/NRAS Mutated Solid Tumors
4/27/2023
Elicio Therapeutics today announced the first patient has been dosed in the Phase 1/2 study of ELI-002 7P (AMPLIFY-7P) in KRAS/NRAS mutated solid tumors at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York.
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RNAimmune Receives FDA Clearance of Investigational New Drug Application for Phase 1 Trial of RV-1730 COVID-19 Booster Vaccine
4/27/2023
RNAimmune, Inc. (the "Company" or "RNAimmune") today announced that the Company has received a clearance from the United States Food & Drug Administration (FDA) cleared its Investigational New Drug (IND) application a Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
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4DMT Presents Positive Interim Data from Intravitreal 4D-150 Phase 1/2 PRISM Clinical Trial in Patients with Wet AMD at ARVO 2023
4/27/2023
4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) today announced positive interim clinical data from the Phase 1 Dose Exploration stage (three doses, n=15) of the 4D-150 Phase 1/2 PRISM clinical trial for wet age-related macular degeneration (wet AMD).
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First Patient Dosed in the US in Avacta’s AVA6000 Phase 1 Clinical Study
4/27/2023
Avacta Group plc announces that the first patient has been dosed in the US under its Investigational New Drug (IND) Application in Avacta’s phase 1 multi-centre trial evaluating the safety and tolerability of AVA6000, a novel tumour targeted form of doxorubicin and Avacta’s first therapeutic product based on its proprietary pre|CISION™ technology.
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Avidity Biosciences Announces Positive Topline Data from AOC 1001 Phase 1/2 MARINA™ Trial Demonstrating Functional Improvement, Disease Modification and Favorable Safety and Tolerability Profile in People Living with Myotonic Dystrophy Type 1
4/27/2023
Avidity Biosciences, Inc. announced positive topline data from the Phase 1/2 MARINA™ clinical trial of AOC 1001 for the treatment of myotonic dystrophy type 1 demonstrating functional improvement, DMPK reduction, splicing improvements and a favorable safety and tolerability profile.
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Skye Bioscience Begins Dosing Phase 1 Fourth Cohort in Clinical Trial of Novel CB1R Agonist
4/27/2023
Skye Bioscience, Inc. (OTCQB: SKYE) ("Skye" or the "Company"), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma and ocular hypertension, has started dosing of the first cohort of its multiple ascending dose ("MAD")
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Biofrontera Inc. Announces Last Patient Out in Phase I Study to Evaluate Safety and Tolerability in Treating Actinic Keratosis Using 3 Tubes of Ameluz(R)
4/26/2023
Biofrontera Inc. today announced that that the last patient in a Phase I study to evaluate the safety and tolerability of Ameluz.
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Avenge Bio Announces Successful Completion of First Dose Level Cohort in Phase 1/2 Clinical Trial of AVB-001 for the Treatment of Ovarian Cancer
4/26/2023
Avenge Bio, Inc. today announced the successful completion of the first dose cohort in a Phase 1/2 clinical trial of AVB-001 in patients with refractory ovarian cancer.
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Calico Life Sciences Announces First Participant Dosed in Phase 1b Clinical Study Evaluating ABBV-CLS-7262 for the Treatment of Vanishing White Matter Disease
4/26/2023
Calico Life Sciences LLC today announced that the first participant has been dosed in a Phase 1b clinical trial, (study M23-523; NCT05757141), evaluating the investigational eIF2B activator ABBV-CLS-7262 as a potential treatment for Vanishing White Matter (VWM) disease.
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RG6501 (OpRegen®) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration - April 26, 2023
4/26/2023
RG6501 (OpRegen ® ) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration.
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Direct Biologics Receives FDA Clearance to Initiate Phase 1b/2a Clinical Trial of ExoFlo™ in Patients with Medically Refractory Perianal Fistulizing Crohn’s Disease
4/26/2023
Direct Biologics, LLC announces U.S. Food and Drug Administration (FDA) clearance of the Company’s investigational new drug (IND) application for a Phase 1b/2a clinical trial to evaluate the safety and efficacy of ExoFlo™ for the treatment of medically refractory perianal fistulizing Crohn’s disease (CD).