Clinical Trial News Archive - July 2020

July 1, 2020

• Everything You Need to Know About Imperial College London's COVID-19 Vaccine Trial
• Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
• Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2

July 2, 2020

• Treatment with Hydroxychloroquine Cut Death Rate Significantly in COVID-19 Patients, Henry Ford Health System Study Shows
• EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab In Hospitalized Patients with COVID-19 Associated Acute Respiratory Distress Syndrome

July 4, 2020

• Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207)

July 6, 2020

• Sinovac COVID-19 Vaccine Collaboration with Butantan Receives Approval from Brazilian Regulator for Phase III Trial
• ObsEva Announces Positive Results from two Phase 3 Studies, PRIMROSE 1 and 2, of Yselty® (linzagolix) for the Treatment of Uterine Fibroids
• Merck Announces New Analyses Showing Additional Safety and Efficacy Data for Investigational Islatravir in Combination with Doravirine in Adults with HIV-1 Infection
• Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Phase 3 LIBERTY Studies in Women with Uterine Fibroids and from Ovulation Inhibition Study
• BELLUS Health Announces Topline Results from its Phase 2 RELIEF Trial of BLU-5937 for the Treatment of Refractory Chronic Cough
• Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus
• Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
• Idorsia Announces Positive Results in the Second Phase 3 Study of Daridorexant
• Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19

July 7, 2020

• Imperial College London's COVID-19 Trial Progresses, as 'Cautious Optimism' Grows for RNA Vaccine
• GSK and Medicago Announce Collaboration to Develop a Novel Adjuvanted COVID-19 Candidate Vaccine
• ViiV Healthcare Announces Superior Efficacy of Investigational, Long-Acting Injectable Formulation of Cabotegravir Dosed Every Two Months Over Daily Oral PrEP
• Novavax Announces $1.6 Billion Funding from Operation Warp Speed
• Regeneron Announces Manufacturing and Supply Agreement for BARDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail

July 8, 2020

• CEPI Expands Partnership with Clover to Rapidly Advance Development and Manufacture of COVID-19 Vaccine Candidate
• Angion Initiates Phase 2 Clinical Trial of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia
• Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)
• The New England Journal of Medicine Publishes Final Results from Phase 1/2 Study of Tofersen for a Genetic Form of ALS
• NIH Launches Clinical Trials Network to Test COVID-19 Vaccines and Other Prevention Tools
• Gilead Sciences Statement on the Initiation of Clinical Testing of an Inhaled Solution of Remdesivir for Potential Outpatient Treatment of COVID-19

July 9, 2020

• Moderna and ROVI Announce Collaboration for OUS Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
• LEO Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of Biologics License Application (BLA) for Tralokinumab for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis
• Bayer’s Finerenone Meets Primary Endpoint in Phase III FIDELIO-DKD Renal Outcomes Study in Patients With Chronic Kidney Disease and Type 2 Diabetes

July 10, 2020

• Gilead Presents Additional Data on Investigational Antiviral Remdesivir for the Treatment of COVID-19
• Atox Bio Announces a Positive Effect of Reltecimod on Resolution of Organ Dysfunction in Phase 3 ACCUTE Trial for Patients with Necrotizing Soft Tissue Infection (“Flesh Eating Disease”)

July 13, 2020

• University of Queensland's COVID-19 Vaccine to Commence Human Trials
• Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2
• Clinical Trial Shows Itolizumab Reduces Mortality In Patients Hospitalized With COVID-19

July 14, 2020

• Albireo Enrolls First Patient in Phase 3 Clinical Trial of Odevixibat in Biliary Atresia
• Moderna Announces Publication in The New England Journal of Medicine of Interim Results From Phase 1 Study of Its mRNA Vaccine Against COVID-19 (mRNA-1273)
• Experimental COVID-19 Vaccine Safe, Generates Immune Response

July 16, 2020

• PhaseBio Doses First Patient in VANGARD Phase 2 Clinical Trial to Evaluate PB1046 for Hospitalized COVID-19 Patients
• Algernon Announces First U.S. Clinical Trial Site in Florida for Phase 2b/3 Human Study of Ifenprodil for COVID-19
• Aprea Therapeutics Announces Expansion of Clinical Trial Evaluating Eprenetapopt for the Front-Line Treatment of TP53 Mutant Acute Myeloid Leukemia (AML)

July 17, 2020

• FDA Grants Fast Track Designation For DB102 in Patients with Newly-Diagnosed Glioblastoma (GBM)
• Lilly's Mirikizumab Superior to Cosentyx (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis

July 20, 2020

• FDA Clears Abivertinib for Phase 2 Safety and Efficacy Study in Hospitalized Patients with Moderate to Severe COVID-19
• Connect Biopharma Initiates Phase 2 Clinical Trial of CBP-201 in Adult Patients with Moderate-to -Severe Atopic Dermatitis
• COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial
• Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data
• GSK and CureVac Announce Strategic mRNA Technology Collaboration
• Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2

July 21, 2020

• Aldeyra Therapeutics Announces New Drug Application (NDA) Development Plans for Dry Eye Disease
• CytoDyn Reports Results From CytoDyn’s Phase 2 COVID-19 Trial for Leronlimab

July 22, 2020

• AzurRx BioPharma Initiates Phase 2b Clinical Trial of MS1819 in Cystic Fibrosis – with First Patient Screened and Three Clinical Trial Sites Activated
• Astellas is Awarded Grant from the U.S. National Institutes of Health (NIH) to Fund Early Clinical Studies of ASP8062 to Investigate Potential Novel Therapeutic Approach to Address the Opioid Crisis
• Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

July 23, 2020

• MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy
• Veru Receives Positive Input from FDA on Phase 3 Pivotal Trial to Evaluate VERU-111 in Metastatic Castration Resistant Prostate Cancer
• Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate

July 26, 2020

• Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19

July 27, 2020

• National Institutes of Health Selects Humanigen’s Lenzilumab for its COVID-19 Big Effect Trial
• Recombinant 2019-nCoV Vaccine of Zhifei Approved for Clinical Trials
• Phase 3 Clinical Trial of Investigational Vaccine for COVID-19 Begins
• Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins
• Aerie Pharmaceuticals Reports Positive Topline Results for AR-1105 (Dexamethasone Intravitreal Implant) Phase 2 Clinical Trial in Patients with Macular Edema Due to Retinal Vein Occlusion

July 28, 2020

• Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN
• Corcept Therapeutics Initiates Phase 3 Trial of Relacorilant in Patients with Cushing’s Syndrome of Adrenal Origin
• Experimental COVID-19 Vaccine Protects Upper and Lower Airways in Nonhuman Primates
• Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study

July 29, 2020

• BARDA Procures Regeneron's REGN-EB3 Investigational Ebola Treatment for National Preparedness
• Regulus Therapeutics Announces FDA Orphan Drug Designation of RGLS4326 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention
• Ridgeback Biotherapeutics LP Announces Priority Review of Biologics License Application for Ansuvimab Ebola Treatment
• INOVIO Receives Orphan Drug Designation From U.S. FDA for DNA Medicine INO-3107 To Treat Rare Disease Recurrent Respiratory Papillomatosis (RRP)

July 30, 2020

• Nirsevimab Reduced Respiratory Syncytial Virus Infections and Hospitalisations in Preterm Infants in Phase IIb Trial
• Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-Clinical Studies
• INOVIO's COVID-19 DNA Vaccine INO-4800 Provides Protection with Memory Immune Responses In Non-Human Primates Challenged with SARS-CoV-2 Virus

July 31, 2020

• Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19
• Pfizer and BioNTech to Supply Japan with 120 Million Doses of Their BNT162 mRNA-Based Vaccine Candidate
• Sanofi and GSK Selected for Operation Warp Speed to Supply United States Government with 100 Million Doses of COVID-19 Vaccine