Clinical Trials - Phase II

Found 27,825 articles

• Artiva Biotherapeutics Announces Presentation of Data from First-in-Human Phase 1/2 Clinical Trial of AB-101 at the 2023 ASCO Annual Meeting

  4/26/2023

  Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that a poster describing initial data from the Phase 1/2 trial of AB-101 will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.

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  Vedanta Raises $106.5M to Advance New Class of C. diff Therapeutics

  4/25/2023

  Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
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  Bluebird Submits BLA for Sickle-Cell Disease Gene Therapy

  4/25/2023

  The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
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  Applied Therapeutics Seeks NDA for Rare Pediatric Disease Drug Despite Phase III Failure

  4/25/2023

  Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.

• PureTech Founded Entity Vedanta Biosciences Announces $106.5 Million Financing to Advance Pipeline of Defined Bacterial Consortia Therapies

  4/25/2023

  PureTech Health plc noted today that its Founded Entity, Vedanta Biosciences today announced that it has raised $106.5 million to support pivotal-stage development of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a Phase 2 study of VE202 for ulcerative colitis, among other development activities.

• Vedanta Biosciences Announces $106.5 Million Financing to Advance Pipeline of Defined Bacterial Consortia Therapies

  4/25/2023

  Vedanta Biosciences today announced that it has raised $106.5 million to support pivotal-stage development of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a Phase 2 study of VE202 for ulcerative colitis, among other development activities.

• First Wave Biopharma Exceeds 50% Enrollment Target for Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

  4/25/2023

  First Wave BioPharma, Inc. today announced that it has now surpassed the 50% enrollment target in its ongoing Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

• Atsena Therapeutics Announces Positive 6-month Data from Ongoing Phase I/II Clinical Trial of ATSN-101 in Patients with Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D (LCA1)

  4/25/2023

  Atsena Therapeutics today announced positive 6-month safety and efficacy data from the ongoing Phase I/II clinical trial of ATSN-101, the company’s investigational gene therapy for the treatment of GUCY2D-associated Leber congenital amaurosis (LCA1).

• Arrowhead Pharmaceuticals’ Proprietary Pulmonary TRiM™ Platform Achieves High Levels of Target Gene Knockdown and Long Duration of Effect

  4/25/2023

  Arrowhead Pharmaceuticals’ Proprietary Pulmonary TRiM ™ Platform Achieves High Levels of Target Gene Knockdown and Long Duration of Effect.

• Morphic Reports Positive Topline Results of the EMERALD-1 UC Main Cohort; Orally Administered MORF-057 Achieves Primary Endpoint and Demonstrates Clinically Meaningful Improvements Across Secondary and Exploratory Measures

  4/25/2023

  Morphic Therapeutic today reported positive topline data from the main cohort of the open-label EMERALD-1 Phase 2a study of MORF-057, an oral small molecule inhibitor of the α4β7 integrin, in adults with moderate to severe ulcerative colitis (UC).

• Vaccinex Completes Enrollment in Phase 1b/2 SIGNAL-AD (Alzheimer’s Disease) Study of Pepinemab

  4/25/2023

  Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced that it has completed enrollment goal in the SIGNAL-AD clinical trial for people with mild dementia due to Alzheimer’s Disease (NCT04381468).

• Baudax Bio Announces Positive Top-Line Final Results From Phase 2 Randomized Clinical Trial of BX1000

  4/25/2023

  Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today announced positive top-line results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery.

• Stoke Therapeutics Receives Authorization to Initiate a Phase 1/2 Study of STK-002 for Autosomal Dominant Optic Atrophy (ADOA) in the United Kingdom

  4/25/2023

  Stoke Therapeutics, Inc. today announced authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1/2 study (OSPREY) of STK-002 for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder.

• Aphaia Pharma Announces Dosing of First Patient in its Phase 2 Trial Evaluating its Lead Candidate APH-012 for Prediabetes

  4/25/2023

  Aphaia Pharma today announced the first patient has been dosed in a Phase 2 study evaluating the safety and efficacy of its lead candidate, APH-012, to improve glucose tolerance in patients with prediabetes.

• OKYO Pharma Announces Activation of First Clinical Trial Site in the U.S. for the Phase 2 Trial Evaluating OK-101 for the Treatment of Dry Eye Disease

  4/25/2023

  OKYO Pharma Limited announces the activation of the first clinical trial site in the U.S. for its phase 2, multi-center, randomized, double-blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with dry eye disease.

• HilleVax Announces Completion of Enrollment of NEST-IN1 Phase 2b Clinical Study of HIL-214 Norovirus Vaccine Candidate

  4/25/2023

  HilleVax, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, announced completion of enrollment of NEST-IN1, with over 3,000 subjects enrolled in six countries.

• Artelo Biosciences Initiates the Phase 2a Portion of its CAReS Trial EvaluatingART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss

  4/25/2023

  Artelo Biosciences, Inc. (Nasdaq: ARTL) today announced it has initiated the Phase 2a portion of its Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 for the treatment of cancer-related anorexia and weight loss.

• Neurona Therapeutics Presents Updated Data from the NRTX-1001 Cell Therapy Trial in Adults with Drug-resistant Focal Epilepsy at American Academy of Neurology (AAN) 2023 Annual Meeting

  4/24/2023

  Neurona Therapeutics announced the presentation of updated clinical data from its ongoing Phase I/II clinical trial of a single dose of NRTX-1001 in people with drug-resistant mesial temporal lobe epilepsy (MTLE).

• BioRestorative Therapies Announces Completion of Patient Enrollment for Safety Run-In Component of its Phase 2 Clinical Study of BRTX-100

  4/24/2023

  BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that it has completed enrollment for the safety run-in component of its Phase 2 clinical study of BRTX-100 targeting patients suffering from chronic lumbar disc disease (cLDD).

• Successful Results Using Sernova’s Cell Pouch System™ with Evotec’s iPSC-Derived Islet-like Clusters for Type 1 Diabetes Presented at the 4th IPITA / HSCI / JDRF Summit

  4/24/2023

  Sernova Corp. announced the presentation of preclinical data supporting the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of patients with T1D.