Company Product Description Indication Status
Phase I
Agios Pharmaceuticals Inc., of Cambridge, Mass. AG-270 MAT2A inhibitor Non-small-cell lung and pancreatic cancers Enrollment slowed due to COVID-19; go/no-go decision still expected no later than 2022
Agios Pharmaceuticals Inc., of Cambridge, Mass. AG-636 DHODH inhibitor Lymphoma As a result of limited enrollment, Agios will stop in-house development of AG-636 and evaluate partnering options
Agios Pharmaceuticals Inc., of Cambridge, Mass. Tibsovo (ivosidenib) Isocitrate dehydrogenase-1 inhibitor Myelodysplastic syndrome Enrollment completion now expected in 2021 vs. previous guidance of end of 2020, due to COVID-19-related delays
Janssen Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson, and Yuhan Corp., of Seoul, Korea YH-25448 Irreversible EGFR tyrosine kinase inhibitor  EGFR-positive advanced non-small-cell lung cancer Recruitment in phase I/II trial temporarily on hold due to COVID-19
Morphosys AG, of Martinsried, Germany MOR-202 Monoclonal antibody targeting CD38 Anti-PLA2R+ membranous nephropathy Recruitment paused in phase I/II study due to COVID-19
Silence Therapeutics plc, of London SLN-124 RNAi therapeutic Beta-thalassemia or myelodysplastic syndromes Study stopped prior to first administered dose due to COVID-19
Spectrum Pharmaceuticals Inc., of Henderson, Nev. Rolontis (eflapegrastim) G-CSF analogue Neutropenia Dosed first patient in trial testing administration on same day as chemotherapy; study will evaluate duration of severe neutropenia when given at 3 different time points on same day following standard chemo in patients with early stage breast cancer
Phase II
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat PKR activator Sickle cell disease Enrollment paused due to COVID-19
Bellus Health Inc., of Laval, Quebec BLU-5397 P2X3 receptor antagonist Unexplained or refractory chronic cough Terminated due to impact of COVID-19 on trial activities
Eli Lilly and Co., of Indianapolis LY-3454738  CD200R monoclonal antibody agonist Chronic spontaneous urticaria Enrollment on hold due to COVID-19 
Gilead Sciences Inc., of Foster City, Calif. GS-9131 Phosphonamidite prodrug of ribose-modified phosphonate nucleotide analogue GS-9148 HIV-1 Study terminated after it did not meet targeted antiviral response
Leo Pharma A/S, of Ballerup, Denmark LEO-138559 Antibody targeting IL-22 Atopic dermatitis Trial in healthy subjects put on hold due to COVID-19
Mesoblast Ltd., of Melbourne, Australia Remestemcel-L Allogeneic mesenchymal stem cell therapy COVID-19 Started enrolling in phase II/III placebo-controlled study to measure whether remestemcel-L provides survival benefit in moderate/severe acute respiratory distress syndrome due to COVID-19
Novartis AG, of Basel, Switzerland Canakinumab Monoclonal antibody targeting IL-1beta Early stage non-small-cell lung cancer Recruitment temporarily paused due to COVID-19 in study testing canakinumab or Keytruda (pembrolizumab, Merck & Co. Inc.) as monotherapy or combination therapy in neoadjuvant treatment 
Palatin Technologies Inc., of Cranbury, N.J. PL-9643 Synthetic peptide Dry eye disease Enrollment of additional cohorts delayed due to COVID-19; anticipates restarting enrollment in June 2020, and data readout remains on track for fourth quarter of 2020
Palatin Technologies Inc., of Cranbury, N.J. PL-8177 Selective MC1r agonist peptide Ulcerative colitis Delay of 2 quarters due to COVID-19; study now targeted to start in first half of 2021, with data readout in first half of 2022
Vertex Inc., of Boston VX-814 Small molecule that corrects misfolding of AAT Alpha-1 antitrypsin deficiency Temporarily paused screening and enrollment due to COVID-19
Phase III
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat PKR activator PK deficiency Top-line data from Activate pivotal trial in patients who do not regularly receive transfusions expected between end of 2020 and mid-2021 vs. previous guidance of end of 2020; potential delay due to anticipated challenges with trial site access after last patient has completed study; enrollment complete at 80 patients
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat PKR activator PK deficiency Top-line data from Activate-T study in patients who regularly receive transfusions expected between end of 2020 and mid-2021 vs. previous guidance of end of 2020; potential delay due to anticipated challenges with trial site access after last patient has completed study; enrollment complete at 27 patients
Agios Pharmaceuticals Inc., of Cambridge, Mass. Tibsovo (ivosidenib) Isocitrate dehydrogenase-1 inhibitor Acute myeloid leukemia Enrollment in Agile study now expected to complete in 2021 vs. previous guidance of end of 2020 due to COVID-19; study testing Tibsovo plus azacitidine in front-line disease
Agios Pharmaceuticals Inc., of Cambridge, Mass. Tibsovo (ivosidenib) Isocitrate dehydrogenase-1 inhibitor Cholangiocarcinoma Expects delays in collecting data from trial sites in ClariDHy study; sBLA expected between end of 2020 and mid-2021 vs. previous guidance of end of 2020
Agios Pharmaceuticals Inc., of Cambridge, Mass. Vorasidenib  Oral inhibitor of IDH1 and IDH2 Low-grade glioma Enrollment in Indigo study slowed due to COVID-19
Eli Lilly and Co., of Indianapolis LY-3009104 (baricitinib) JAK1/2 inhibitor Active JIA-associated uveitis or chronic anterior antinuclear antibody-positive uveitis Enrollment on hold due to COVID-19
Glaxosmithkline plc, of London GSK-3196165 (otilimab) Monoclonal antibody targeting GM-CSF Rheumatoid arthritis Study testing drug vs. placebo and sarilumab in patients with moderately to severely active disease who have inadequate response to disease-modifying therapy and/or JAK inhibitors temporarily suspended recruitment due to COVID-19
Glaxosmithkline plc, of London GSK-3196165 (otilimab) Monoclonal antibody targeting GM-CSF Rheumatoid arthritis Study testing drug vs. placebo and tofacitinib in patients with moderately to severely active disease who have inadequate response to methotrexate temporarily suspended recruitment due to COVID-19
Jazz Pharmaceuticals plc, of Dublin Defibrotide Anti-clotting drug Hepatic veno-occlusive disease post-hematopoietic stem cell transplantation Enrolling in study in high-risk or very high-risk patients is being discontinued; enrollment stopped early based on recommendation of independent data monitoring committee that study was highly unlikely to reach statistical significance for primary endpoint of VOD-free survival at day 30 post-HSCT in final analysis 
Novartis AG, of Basel, Switzerland Brolucizumab VEGF inhibitor Diabetic macular edema Recruitment in study in Chinese patients with visual impairment due to DME temporarily paused due to safety measure
Novartis AG, of Basel, Switzerland Brolucizumab VEGF inhibitor Neovascular age-related macular degeneration Recruitment in study vs. aflibercept in Chinese patients temporarily paused due to safety measure
Novartis AG, of Basel, Switzerland Secukinumab Antibody targeting IL-17A Plaque psoriasis and coexisting nonalcoholic fatty liver disease Study suspended due to COVID-19
Novartis AG, of Basel, Switzerland Secukinumab Antibody targeting IL-17A Hidradenitis suppurativa Suspended due to COVID-19
Novartis AG, of Basel, Switzerland Crizanlizumab P-selectin-targeting monoclonal antibody Sickle cell disease Recruitment temporarily paused due to COVID-19 in trial enrolling adolescent and adult patients
Sanofi Pasteur, a unit of Sanofi SA, of Paris VRVg-2 Purified vero rabies vaccine  Rabies Suspended due to COVID-19
Soligenix Inc., of Princeton, N.J. SGX-301 Synthetic hypericin Early stage cutaneous T-cell lymphoma Continued treatment twice weekly for 12 weeks increased positive response rate to 40% (p<0.0001 vs. placebo and p<0.0001 vs. 6-weeks treatment) in open-label treatment cycle (referred to as cycle 2) of pivotal Flash study
Urogen Pharma Ltd., of Princeton, N.J. Jelmyto (UGN-101; mitomycin) Chemotherapy pus sterile hydrogel Low-grade upper tract urothelial cancer Results from Olympus trial published in The Lancet Oncology show 59% of patients treated with Jelmyto achieved complete response; durability at 12 months was estimated to be 84% by Kaplan-Meier analysis
Phase IV
Eli Lilly and Co., of Indianapolis Abemaciclib CKD4/6 inhibitor HR-positive, HER2-negative metastatic breast cancer Enrolling in study testing combination with fulvestrant vs. chemotherapy on hold due to COVID-19
Eli Lilly and Co., of Indianapolis LY-2963016 Insulin glargine biosimilar Type 2 diabetes Study in India suspended due to COVID-19
Eli Lilly and Co., of Indianapolis LY-3009104 (baricitinib) JAK1/2 inhibitor Rheumatoid arthritis Enrollment on hold in Ra-Branch study due to COVID-19
Mallinckrodt plc, of Staines-upon-Thames, U.K. Acthar Gel (repository corticotropin injection) Adrenocorticotrophic hormone ligand Severe keratitis Study testing impact on everyday life of patients temporarily suspended due to COVID-19

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments