Clinical Trial News Archive - June 2020

June 1, 2020

• Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids
• Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

June 3, 2020

• Complete Results from Second Pivotal Monotherapy Study of Abrocitinib Published in JAMA Dermatology

June 4, 2020

• Novavax Awarded Department of Defense Contract for COVID-19 Vaccine
• ObsEva Announces Publication of Data Showing Efficacy of Linzagolix in a Potential New Indication for Treatment of Adenomyosis
• AstraZeneca Takes Next Steps Towards Broad and Equitable Access to Oxford University’s COVID-19 Vaccine
• GSK Announces New Data Presentations from the DREAMM Programme Exploring Investigational Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma

June 5, 2020

• Calquence Showed Promising Clinical Improvement in Majority of 19 Hospitalised COVID-19 Patients

June 7, 2020

• Alnylam Presents Positive Phase 3 Results from ILLUMINATE-A Study of Lumasiran, an Investigational RNAi Therapeutic for Treatment of Primary Hyperoxaluria Type 1

June 8, 2020

• Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease
• Lilly Announces Start of a Phase 1 Study for its Second Potential COVID-19 Antibody Treatment

June 9, 2020

• First Patient Dose Delivered for Lilly's Tirzepatide Cardiovascular Outcomes Trial

June 10, 2020

• Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July
• RedHill Biopharma Submits COVID-19 Clinical Trial Application for Phase 2/3 Study with Opaganib
• Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in Adolescents with Moderate-to-Severe Atopic Dermatitis
• Galidesivir Stops Zika Viral Replication in Primate Model

June 11, 2020

• Moderna Advances Late-Stage Development of its Vaccine (mRNA-1273) Against COVID-19
• CytoDyn Initiates Phase 2 Clinical Trial With Leronlimab for Treatment of NASH
• Regeneron Begins First Clinical Trials of Anti-Viral Antibody Cocktail REGN-COV2 for the Treatment and Prevention of COVID-19
• Two Science Publications Highlight Potential of REGN-COV2 Anti-Viral Antibody Cocktail to Protect Against SARS-CoV-2 Escape Mutants
• Genexine's COVID-19 Preventive Vaccine GX-19 Receives Clinical 1/2 phase Approval

June 12, 2020

• Tralokinumab Achieves Primary and Secondary Endpoints in Three Pivotal Phase 3 Trials in Adult Patients with Moderate-to-Severe Atopic Dermatitis
• Genentech Announces 2-Year Risdiplam Data From SUNFISH and New Data From JEWELFISH in Infants, Children and Adults With Spinal Muscular Atrophy (SMA)
• Lilly and Dermira Present New Lebrikizumab Phase 2b Clinical Data Showing Patients with Atopic Dermatitis Had Clinically Meaningful Improvements in Itch, Sleep and Quality of Life Data presented at virtual American Academy of Dermatology 2020 Annual Meeting
• Pfenex Announces U.S. Commercial Launch of Teriparatide Injection

June 13, 2020

• Sinovac Announces Positive Preliminary Results of Phase I/II Clinical Trials for Inactivated Vaccine Candidate Against COVID-19
• AstraZeneca to Supply Europe With Up To 400 Million Doses of Oxford University’s COVID-19 Vaccine At No Profit

June 14, 2020

• Investigational, Once-Weekly Insulin Icodec Showed Comparable Efficacy and Safety to Once-Daily Insulin Glargine U100 in Phase 2 Trial

June 15, 2020

• Imperial to Begin First Human Trials of New COVID-19 Vaccine
• Mayo Clinic Study of Humanigen’s Lenzilumab Shows Rapid Recovery and Discharge in Severe and Critical COVID-19 Patients
• Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients
• Provention Bio's Teplizumab Continued to Significantly Delay the Onset of Insulin-Dependent Type 1 Diabetes (T1D) in Presymptomatic Patients
• Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis

June 16, 2020

• Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate

June 17, 2020

• CureVac Receives Regulatory Approval from German and Belgian Authorities to Initiate Phase 1 Clinical Trial of its SARS-CoV-2 Vaccine Candidate
• BioMarin Provides Additional Data from Recent 4 Year Update of Ongoing Phase 1/2 Study of Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A in Late-Breaking Oral Presentation at World Federation of Hemophilia Virtual Summit
• Gilead Sciences Statement on Phase 2/3 Clinical Trial of Remdesivir in Pediatric Patients Hospitalized With COVID-19

June 18, 2020

• Chi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer
• Genentech’s IPATential150 Study Evaluating Ipatasertib in Combination With Abiraterone and Prednisone/Prednisolone Met One of Its Co-Primary Endpoints
• Pfizer and Sangamo Announce Updated Phase 1/2 Results Showing Sustained Factor VIII Activity Levels and No Bleeding Events or Factor Usage in 3e13 vg/kg Cohort Following Giroctocogene Fitelparvovec (SB-525) Gene Therapy

June 19, 2020

• GSK Announces FDA Advisory Committee Meeting to Review Belantamab Mafodotin for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
• Clover Initiates Phase 1 Clinical Trial for COVID-19 Vaccine Candidate
• Ridgeback Biotherapeutics Announces Launch of Phase 2 Trials Testing EIDD-2801 as Potential Treatment for COVID-19
• GSK COVID-19 Vaccine Development Collaboration with Clover Biopharmaceuticals Begins Clinical Trials

June 20, 2020

• Glenmark Becomes the First Pharmaceutical Company in India to Receive Regulatory Approval for Oral Antiviral Favipiravir for the Treatment of Mild to Moderate COVID-19
• NIH Halts Clinical Trial of Hydroxychloroquine

June 22, 2020

• Merck Announces That V114, Its Investigational 15-valent Pneumococcal Conjugate Vaccine, Met Safety and Immunogenicity Objectives in Initial Phase 3 Studies in Adults
• Myovant Sciences Announces Priority Review and FDA Acceptance of New Drug Application for Once-Daily, Oral Relugolix for Advanced Prostate Cancer
• Pfizer Announces Start of Four Phase 3 Clinical Trials for Investigational Vaccines

June 23, 2020

• FibroGen Announces First Patient Enrolled in Pamrevlumab Clinical Trial in Patients Hospitalized in U.S. with Acute COVID-19
• Myovant Sciences Announces Positive Results from Second Phase 3 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis
• First Volunteer Receives Imperial College London's COVID-19 Vaccine

June 24, 2020

• NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19
• Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients

June 25, 2020

• Breztri Aerosphere Significantly Reduced Rate of Moderate or Severe COPD Exacerbations in Phase III ETHOS Trial
• Moderna and Catalent Announce Collaboration for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
• Theravance Biopharma Announces First Patient Dosed in Phase 2 Study of TD-0903 for the Treatment of Hospitalized Patients with Acute Lung Injury Caused by COVID-19

June 26, 2020

• Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol
• Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
• Vaxart’s COVID-19 Vaccine Selected for the U.S. Government’s Operation Warp Speed

June 29, 2020

• Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections
• Genmab Announces Very Favorable Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
• Recombinant Novel Coronavirus Vaccine (adenovirus type 5 Vector) Received Military Specially-Needed Drug Approval in China

June 30, 2020

• INOVIO Announces Positive Interim Phase 1 Data For INO-4800 Vaccine for COVID-19