Clinical Trials - Phase II

Found 27,825 articles

• Scorpion Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of STX-478, Its Mutant-Selective PI3Kα Inhibitor for the Treatment of Breast Cancer and Other Solid Tumors

  5/2/2023

  Scorpion Therapeutics, Inc. today announced that the first patient has been dosed in a Phase 1/2 first-in-human dose escalation and expansion clinical trial evaluating STX-478.

• Completion of Enrollment in Cohorts C and G of China Phase II Clinical Study of Osemitamab (TST001) in Combination with CAPOX with or without Nivolumab as First-line Treatment of Gastric/Gastro-esophageal Junction Cancer Patients

  5/2/2023

  Transcenta Holding Limited ("Transcenta") (HKEX: 06628) announces that the enrollment of first-line (1L) CLDN18.2 expressing Gastric / Gastro-esophageal Junction (G/GEJ) adenocarcinoma patients in cohorts C and G for the China Phase II study (Transtar-102, NCT04495296) of its high affinity humanized ADCC-enhanced anti-CLDN18.2 monoclonal antibody Osemitamab (TST001) has been completed.

• Protara Therapeutics Receives Regulatory Clearance from FDA to Commence Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations

  5/2/2023

  Protara Therapeutics, Inc. (Nasdaq: TARA) today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) on its planned Phase 2 STARBORN-1 trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of pediatric patients with lymphatic malformations (LMs).

• SciSparc Completed Treatment of Last Patient Enrolled for its Phase IIa Clinical Trial for Alzheimer's Disease and Agitation

  5/2/2023

  SciSparc Ltd today announced that the last patient enrolled in the Company's Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation, completed its treatment.

• AnaptysBio Announces British Journal of Dermatology Publication of Imsidolimab (IL-36R) Previously Reported Phase 2 GALLOP Data in Generalized Pustular Psoriasis (GPP)

  5/2/2023

  AnaptysBio, Inc. (Nasdaq: ANAB) today announced the publication of data from the open-label, single-arm Phase 2 GALLOP study evaluating the efficacy, tolerability and safety of imsidolimab, its investigational anti-interleukin-36 receptor (IL-36R) IgG4 antibody for the treatment of generalized pustular psoriasis (GPP), in the British Journal of Dermatology.

• Horizon Therapeutics plc Announces First Patient Enrolled in Phase 2 Trial Evaluating Daxdilimab for the Treatment of Lupus Nephritis

  5/2/2023

  Horizon Therapeutics plc (Nasdaq: HZNP) today announced the first patient has enrolled in a Phase 2 randomized placebo-controlled trial to evaluate its development-stage medicine daxdilimab, a potentially first-in-class, fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7) that depletes certain dendritic cells, to treat people with active proliferative lupus nephritis (LN).

• Moleculin Successfully Completes First Cohort in Phase 1b/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

  5/2/2023

  Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company") today announced the successful completion of the first cohort in the Phase 1b portion of its Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of AML (MB-106).

• Ascletis Announces ASC40, a First-in-Class, Once-Daily Oral FASN Inhibitor, Achieved Endpoints in Phase II Clinical Trial for Acne

  5/2/2023

  Ascletis Pharma Inc. announces that ASC40, a first-in-class, once-daily oral fatty acid synthase inhibitor, achieved primary and key secondary endpoints in Phase II clinical trial for acne vulgaris.

• OKYO Pharma Announces First-Patient First-Visit for Phase 2 Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye Disease

  5/2/2023

  OKYO Pharma Limited is pleased to announce that the first patient has been screened 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.

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  Walgreens Launches Partnership with Prothena to Compete with CVS, Walmart

  5/1/2023

  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.
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  Natural History Studies Drive Data Sharing, Drug Approval

  5/1/2023

  Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.

• CG Oncology Announces New Phase 2 Data with Cretostimogene Grenadenorepvec (CG0070) in Combination with KEYTRUDA® (pembrolizumab) in BCG-Unresponsive NMIBC

  5/1/2023

  CG Oncology, Inc. announced updated data from the CORE-001 study, an ongoing Phase 2 clinical trial of cretostimogene grenadenorepvec (CG0070) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

• Incyte Announces Results from SCRATCH-AD Trial Demonstrating Substantial and Rapid Itch Reduction in Patients with Mild-Moderate Atopic Dermatitis Treated with Opzelura® (ruxolitinib) Cream

  5/1/2023

  Incyte (Nasdaq:INCY) today announced new data from the Phase 2 SCRATCH-AD trial evaluating the short-term clinical benefits of Opzelura® (ruxolitinib) cream 1.5% to control pruritus (itching) and reduce disease severity in adult patients with atopic dermatitis (AD), the most common type of eczema.

• 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).

• Silence Therapeutics Completes Enrollment in Phase 2 Study of Zerlasiran (SLN360) in Subjects with Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

  5/1/2023

  Silence Therapeutics plc today announced that it has completed enrollment in the ALPACAR-360 phase 2 study of zerlasiran (SLN360) in subjects with elevated lipoprotein(a) (“Lp(a)”) at high risk of atherosclerotic cardiovascular disease (“ASCVD”) events.

• Pliant Therapeutics Announces Positive Long-Term Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast was Well Tolerated at 320 mg with Durable Improvement Shown in FVC and Across Multiple Measures

  4/30/2023

  Pliant Therapeutics, Inc. announced 24-week data from the 320 mg dose group of INTEGRIS-IPF, a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with idiopathic pulmonary fibrosis.

• Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer

  4/30/2023

  The Janssen Pharmaceutical Companies of Johnson & Johnson announced the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy and cetrelimab monotherapy in patients with Bacillus Calmette-Guérin -unresponsive high-risk non-muscle-invasive bladder cancer, who are ineligible for, or decline, radical cystectomy.

• 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).

• OliX Pharmaceuticals Announces Positive Results from a Phase 2a Trial of OLX10010 for Hypertrophic Scar Treatment

  4/28/2023

  OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced positive headline results of a phase 2a trial in the treatment of hypertrophic scars which met the primary observer-based endpoint at week 24 as evaluated by the Patient and Observer Scar Assessment Scale (POSAS).

• Senhwa Biosciences Received Taiwan FDA IND Approval for Phase II Study of Silmitasertib in Patients with Moderate to Severe COVID-19

  4/28/2023

  Senhwa Biosciences, Inc. announced today that Taiwan FDA has approved its Phase II IND application of Silmitasertib(CX-4945) to treat hospitalized patients with moderate to severe COVID-1.