Company Product Description Indication Status
Phase I
89bio Inc., of San Francisco BIO89-100 FGF receptor agonist; FGF-21 ligand Nonalcoholic steatohepatitis Closed enrollment in phase Ib/IIa trial, randomizing 81 participants to weekly or every other week subcutaneous dosing or placebo for 12 weeks; efficacy endpoint of absolute change from baseline in hepatic fat fraction, measured by MRI-PDFF, will be assessed at week 7 and end of trial; top-line data expected in second half of 2020
Aslan Pharmaceuticals Ltd., of Singapore ASLAN-004 IL-13/IL-4 receptor antagonist Atopic dermatitis Recruitment in multiple ascending-dose study enrolling adults with moderate to severe disease paused due to COVID-19 pandemic; screening expected to resume in May 2020, with interim unblinded data still expected to report in 2020
Bausch Health Cos. Inc., of Laval, Quebec Virazole (ribavirin inhalation solution) Inosine monophosphate dehydrogenase inhibitor COVID-19-related respiratory distress Program initiated in Canada to evaluate study drug in combination with standard-of-care therapy to treat hospitalized adults; initial study approved by Health Canada and expected to begin within several weeks; discussions underway with additional regulators to expand program
Nextcure Inc., of Beltsville, Md. NC-318 Sialic acid-binding Ig-like lectin 15 inhibitor Advanced solid tumors Company continuing to support those enrolled in phase II portion of phase I/II monotherapy trial and working with sites to enroll additional participants as appropriate in light of COVID-19 pandemic; initial biomarker data from phase I portion expected in midyear 2020 but top-line data from phase II portion expected to be delayed
Nextcure Inc., of Beltsville, Md. NC-410 Leukocyte associated Ig like receptor 1 antagonist Undisclosed cancer Initiation of phase I portion of phase I/II trial, originally expected to begin in March, delayed due to COVID-19 pandemic
Prolynx LLC, of San Francisco PLX-038  Topoisomerase I inhibitor Small-cell lung cancer First participant treated at NCI in phase Ib combination trial with PARP inhibitor rucaparib (Rubraca, Clovis Oncology Inc.)
Phase II
89bio Inc., of San Francisco BIO89-100 FGF receptor agonist; FGF-21 ligand Nonalcoholic steatohepatitis Initiation of phase IIb trial now expected in first half of 2021, delayed from first half of 2020, due to COVID-19 pandemic
Eli Lilly and Co., of Indianapolis LY-3127804 Angiopoietin ligand-2 inhibitor COVID-19-related pneumonia Trial in hospitalized patients at high risk of progressing to acute respiratory distress syndrome expected to begin in April 2020 at multiple U.S. sites
Nextcure Inc., of Beltsville, Md. NC-318 Sialic acid-binding Ig-like lectin 15 inhibitor Advanced solid tumors; non-small-cell lung cancer Initiation of combination trial with standard-of-care chemotherapies delayed due to COVID-19 pandemic
Phase III
Eli Lilly and Co., of Indianapolis Olumiant (baricitinib) JAK1/JAK2 inhibitor COVID-19 infection Drug added as arm in NIAID-sponsored Adaptive COVID-19 Treatment Trial to treat inflammatory activity in hospitalized individuals
Kolon Tissuegene Inc. TG-C Allogeneic cell and gene therapy Knee osteoarthritis FDA clinical hold lifted, effective April 10, 2020; trial had been suspended due to product identify concerns; company has begun activities to resume and reinitiate enrollment later in 2020

Notes

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

No Comments