Company Product Description Indication Status
Phase I
Lineage Cell Therapeutics Inc., of Carlsbad, Calif. Opregen Human embryonic stem cell-derived retinal pigmented epithelial cells Dry age-related macular degeneration Pooled cohort 4 data from phase I/IIa study, published online via ARVOLearn platform, showed > 10-letter sustained visual acuity improvement over follow‑up period; reading center assessments of geographic atrophy suggested reduction in progression in treated eye vs. fellow eye
Noxopharm Ltd., of Sydney Veyonda (idronoxil) S1P inhibitor Metastatic castration-resistant prostate cancer Radiographic review of Darrt-1 study combining study drug and low-dose radiotherapy showed 27% incidence of abscopal response in soft tissue lesions in 15 participants post-taxane and ADT therapy
Scholar Rock Holding Corp., of Cambridge, Mass. SRK-181 TGF-beta-1 inhibitor Advanced solid tumors Dosing initiated in dose-escalation/expansion Dragon trial; part A to evaluate study drug as single agent and in combination with approved anti-PD-L1 therapy, followed by part B, evaluating combination in multiple tumor-specific cohorts; with slowed enrollment pace due to COVID-19 pandemic, part A update expected in fourth quarter of 2020, with clinical response and safety data in 2021
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (repurposed ifenprodil) NMDA receptor antagonist Idiopathic pulmonary fibrosis; chronic cough Ethics approval received from Royal Brisbane & Women’s Hospital covering 2 sites for planned study, expected to begin enrolling by end of second quarter of 2020
Axcella Health Inc., of Cambridge, Mass. AXA-1125 + AXA-1957 Endogenous metabolic modulators Nonalcoholic fatty liver disease Top-line data from AXA1125-003 study in 102 adults showed, vs. placebo, AXA-1125 demonstrated larger and more consistent reductions in clinically relevant biomarkers than AXA-1957; 39% of those who received AXA-1125 achieved ≥30% relative reduction in liver fat content, 39% achieved ≥17 U/L reduction in alanine aminotransaminase and 35% achieved ≥80 mSec reduction in corrected T1; in 11 with type 2 diabetes who received AXA-1125, greater proportion achieved same thresholds
Eisai Inc., of Woodcliff Lake, N.J. Eribulin Microtubule inhibitor Brain metastases from HER-negative breast cancer Trial withdrawn
Eli Lilly and Co., of Indianapolis Pegilodecakin (LY-3500518) Immunotherapy Non-small-cell lung cancer Cypress-1 trial closed early after final planned analysis because risk-benefit ratio is unfavorable; study testing combination with Keytruda (pembrolizumab, Merck & Co. Inc.) vs. pembrolizumab alone in patients with second-line, metastatic disease
Eli Lilly and Co., of Indianapolis Pegilodecakin (LY-3500518) Immunotherapy Non-small-cell lung cancer Cypress-2 trial closed early after final planned analysis because risk-benefit ratio is unfavorable; study testing combination with Opdivo (nivolumab, Bristol Myers Squibb Co.) vs. nivolumab alone in patients with second-line, metastatic disease
Galecto Inc., of Copenhagen, Denmark GB-0139 Galectin-3 inhibitor Idiopathic pulmonary fibrosis >150 participants recruited into phase IIb Galactic-1 study, which remains on track for data readout in 2022, despite COVID-19 pandemic
Jounce Therapeutics Inc., of Cambridge, Mass. Vopratelimab Agonist monoclonal antibody that specifically binds to ICOS Non-small-cell lung cancer 2- or 3-month delay due to COVID-19 expected for interim analysis data from Emerge study testing drug plus Yervoy (ipilimumab, Bristol Myers Squibb Co.) in patients who have progressed on or after both a platinum-based regimen and a PD-1 or PD-L1 inhibitor; interim analysis now shifted into early 2021
Jounce Therapeutics Inc., of Cambridge, Mass. Vopratelimab plus JTX-4014 ICOS-targeting antibody plus PD-1 checkpoint inhibitor Non-small-cell lung cancer Start delayed by 2 or 3 months due to COVID-19 for Select trial testing combination vs. JTX-4014 alone in PD-1 inhibitor-naïve TISvopra biomarker-selected patients with second-line disease; company still expects to report clinical data in 2021
Mesoblast Ltd., of Melbourne, Australia Remestemcel-L (Ryoncil) Mesenchymal stem cell therapy Acute respiratory distress syndrome First of about 300 participants with COVID-19 infection dosed in U.S. phase II/III trial assessing treatment of moderate to severe ARDS in individuals on ventilator support under emergency IND application or expanded access protocol; primary endpoint is all-cause mortality within 30 days of randomization; full enrollment expected within 3-4 months
Oncosec Medical Inc., of Pennington, N.J. Tavokinogene telseplasmid IL-12 gene stimulator Metastatic melanoma Data published in Clinical Cancer Research showed study drug, in combination with anti-PD-1 inhibitor Keytruda (pembrolizumab, Merck and Co. Inc.), resulted in 41% overall response rate and 36% complete response
Teva Pharmaceutical Industries Ltd., of Jerusalem TV-1106 Growth hormone ligand Growth hormone deficiency Study in treatment-naïve, pre-pubertal, growth hormone-deficient children terminated due to business decision
Phase III
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. Onpattro (patisiran) RNAi therapeutic ATTR amyloidosis with cardiomyopathy Disclosed in first-quarter 2020 earnings that, due to impact of COVID-19, enrollment delays in Apollo-B study will result in shift in enrollment completion date from late 2020 into 2021
Amgen Inc., of Thousand Oaks, Calif. Otezla (apremilast)  PDE4 inhibitor Plaque psoriasis Advance trial in 595 adults with mild to moderate disease showed 30 mg twice daily achieved statistically significant improvement vs. placebo in primary endpoint of static Physician's Global Assessment response (score of clear or almost clear with at least 2-point reduction from baseline) at week 16; secondary endpoints also showed statistically significant response vs. placebo
Humanigen Inc., of Burlingame, Calif. Lenzilumab GM-CSF ligand inhibitor COVID-19 infection First participant dosed in pivotal study assessing ability to prevent or minimize cytokine storm associated with infection
Merck & Co. Inc., of Kenilworth, N.J. Recarbrio (imipenem + cilastatin + relebactam) Beta lactamase inhibitor; dehydropeptidase-1 inhibitor Hospital-acquired/ventilator-associated bacterial pneumonia In Restore-Imi 2 trial, Recarbrio showed noninferiority vs. active comparator piperacillin + tazobactam in primary and key secondary endpoints of 28-day all-cause mortality and clinical response, respectively; results posted in conjunction with publication of study abstracts by 30th European Congress of Clinical Microbiology & Infectious Diseases
Merck, Sharp & Dohme Corp., part of Kenilworth, N.J.-based Merck & Co. Inc. MK-8228 (letermovir) Antiviral drug Prevention of human cytomegalovirus infection and disease Trial testing drug in adult Japanese kidney transplant recipients suspended due to COVID-19
Nucana plc, of Edinburgh, U.K. Acelarin (fosgemcitabine palabenamide, NUC-1031) Gemcitabine prodrug Biliary tract cancer Enrollment re-opened in global Nutide:121 combination study with cisplatin following pause due to COVID-19 pandemic
Rebiotix Inc., of Roseville, Minn., and Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland RBX-2660 Microbiota-based therapy Clostridium difficile infection Preliminary findings from ongoing pivotal Punch CD3 trial deemed positive for primary efficacy endpoint of absence of C. difficile diarrhea without need for retreatment; full data expected by year-end 2020
Rigel Pharmaceuticals Inc., of South San Francisco Tavalisse (fostamatinib disodium hexahydrate) Immunomodulatory agent Warm autoimmune hemolytic anemia Forward study has enrolled 41 patients to date; however, majority of trial sites have temporarily postponed new enrollment due to COVID-19, and company no longer able to provide guidance on timing of enrollment completion
Spero Therapeutics Inc., of Cambridge, Mass. Tebipenem pivoxil hydrobromide Carbapenem-class antibiotic Complicated urinary tract infection; acute pyelonephritis  Enrollment of >1,370 participants completed in pivotal Adapt-PO trial comparing oral extended-release against intravenous formulation; top-line data expected in third quarter of 2020

Notes

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

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