Clinical Trials (Phase II)
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Despite multiple therapeutics approved to treat localized symptoms, there are currently no systemic therapies on the market for Sjogren’s syndrome. -
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners. -
New Data from Phase 1/2 Trial of INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis Presented at ABEA during COSM 2023
5/8/2023
INOVIO presented new data from a Phase 1/2 trial of INO-3107 (NCT:04398433) for the treatment of HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis (RRP) on May 5th as part of the scientific program of the American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts.
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Viatris Reports Strong Financial and Operational Results for First Quarter 2023 and Reaffirms Full-Year 2023 Guidance Ranges[1]
5/8/2023
Viatris Inc. (NASDAQ: VTRS) today reported strong results for the first quarter of 2023 reflecting another robust operational performance and instilling further confidence in the Company's ability to return to growth as it prepares to enter Phase 2 of its strategic plan in 2024.
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Trefoil Therapeutics’ Lead Investigational Candidate TTHX1114 Improves Rate of Visual Recovery after Descemet Stripping Only (DSO) in Phase 2 STORM Data Presented at ASCRS Annual Meeting
5/8/2023
Trefoil Therapeutics today announced that TTHX1114 was found to improve the rate of visual recovery and corneal deturgescence (state of relative dehydration maintained by the normal cornea that is necessary for transparency) after Descemet Stripping Only (DSO) in a dose-responsive manner in the Phase 2 STORM study.
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Enanta Pharmaceuticals Reports Positive Topline Results from Phase 2 SPRINT Trial Evaluating EDP-235 in Standard Risk Patients with COVID-19
5/8/2023
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA) today announced topline data from SPRINT (SARS-Cov-2 PRotease INhibitor Treatment), a double-blind, placebo-controlled Phase 2 clinical trial of EDP-235, Enanta’s oral, 3CL protease inhibitor, in non-hospitalized, symptomatic adults with mild or moderate COVID-19 who were not at high risk for severe disease.
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CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK
5/8/2023
CureVac N.V. today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK.
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Vedanta Biosciences Receives Fast Track Designation for VE303 and Presents Phase 2 Data at Digestive Disease Week
5/8/2023
Vedanta Biosciences today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (rCDI).
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Ascletis Announces China NMPA Approval of Conducting a Phase IIa Clinical Trial for ASC10 to Treat Respiratory Syncytial Virus Infection
5/8/2023
Ascletis Pharma Inc. announces that the China National Medical Products Administration has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus infection.
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Renibus Reports Positive Final Results from Phase 2 Study of RBT-1, a First-in-Class Preconditioning Agent for Patients Undergoing Cardiothoracic Surgery, at the American Association for Thoracic Surgery (AATS) Meeting
5/7/2023
Renibus Therapeutics® presented positive final results from a Phase 2 trial evaluating RBT-1 in patients undergoing elective cardiac surgery during an oral presentation at the 103rd Annual American Association for Thoracic Surgery meeting at the Los Angeles Convention Center, taking place May 6-9, 2023 in Los Angeles, CA.
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The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas. -
Targeting RAS: Golden Biotech Announces Positive Results with Longer Survival Compared with Standard Treatments from Interim Analysis of Phase 2 Trial for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer
5/5/2023
Golden Biotechnology Corp. announces the release of positive interim results from its Phase II clinical trial of Antroquinonol in combination with the standard of care nab-paclitaxel + gemcitabine for first-line treatment of metastatic pancreatic cancer.
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Pieris Pharmaceuticals Announces Successful Completion of Safety Review for 10 mg Dose of Phase 2a Trial of Elarekibep (PRS-060/AZD1402)
5/4/2023
Pieris Pharmaceuticals, Inc. today announced the successful safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder inhaler-formulated elarekibep (PRS-060/AZD1402).
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Alphyn Biologics Reports Positive Pediatric Results from Phase 2a Atopic Dermatitis Trial
5/4/2023
Alphyn Biologics announced positive results today from the pediatric population enrolled in its Phase 2a clinical trial of AB-101a, a novel topical candidate for mild-to-moderate atopic dermatitis (AD), at the 22nd European Society for Pediatric Dermatology Congress (ESPD).
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Presentation of Spago Nanomedical's Clinical Phase IIa Study in Endometriosis at the 15th World Congress of Endometriosis
5/4/2023
Spago Nanomedical (STO:SPAGO.ST)(FRA:7UX.F) Spago Nanomedical AB (publ) announces today that principal investigator Dr Ligita Jokubkiene is participating in the 15th World Congress on Endometriosis scientific conference where she will present observations from the ongoing phase IIa clinical study SPAGOPIX-02 evaluating the contrast agent SN132D in endometriosis.
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Scilex Holding Company Announces Complete Enrollment of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, for the Treatment of Acute Low Back Pain
5/4/2023
Scilex Holding Company (Nasdaq: SCLX, “Scilex”) announced complete enrollment in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% triple strength formulation for ZTlido®, in subjects with acute LBP.
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Endogena Therapeutics Completes Enrollment Ahead of Schedule in its Phase 1/2a Trial of EA-2353 for Retinitis Pigmentosa
5/4/2023
Endogena Therapeutics Inc., a clinical-stage biotech company, is pleased to announce that it has completed patient enrollment ahead of schedule in its Phase 1/2a trial of EA-2353 for the treatment of retinitis pigmentosa.
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SAB Biotherapeutics Presents Positive Phase 1 and 2a Data for SAB-176 Influenza Immunotherapy at ISIRV-AVG Conference
5/4/2023
SAB Biotherapeutics (Nasdaq: SABS), (SAB) today announced the presentation of positive safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176 at the AVG conference, which is hosted by the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) in Seattle, Wash.
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Karyopharm Announces Presentation of Interim Data from Phase 2 Study of Single-Agent Eltanexor in Relapsed/Refractory (R/R) Higher-Risk Myelodysplastic Neoplasms (MDS) at 17th International Congress on MDS
5/3/2023
Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced interim data from the Phase 2 portion of the open-label Phase 1/2 study of single-agent eltanexor in patients with higher R/R myelodysplastic neoplasms.
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Hyundai Bioscience announced positive phase 2 clinical study results of the global blockbuster candidate for the COVID-19 antiviral drug
5/3/2023
Hyundai Bioscience announced on the 28th that it had received the clinical study report for the COVID-19 phase 2 clinical trial of its antiviral drug 'Xafty'.