Company Product Description Indication Status
Phase I
Innovation Pharmaceuticals Inc., of Beverly, Mass. Brilacidin Defensin peptidomimetic Ulcerative colitis Screening for trial of delayed-release tablets in healthy volunteers expected to begin in early January following approval from U.K.'s MHRA; study to assess safety, tolerability and pharmacokinetics of oral drug and evaluate delivery directly to colon
Phase II
Spectrum Pharmaceuticals Inc., of Henderson, Nev. Poziotinib  EGFR family tyrosine kinase inhibitor Non-small-cell lung cancer Prespecified primary endpoint was not met in cohort 1 of Zenith20 trial that enrolled 115 individuals with previously treated NSCLC with EGFR exon 20 insertion mutations; 17 participants had response by RECIST and 62 had stable disease for 68.7% disease control rate; confirmed objective response rate was 14.8%; median duration of response was 7.4 months
Spring Bank Pharmaceuticals Inc., of Hopkinton, Mass. Inarigivir NOD2 gene stimulator; retinoic acid-inducible gene 1 stimulator Hepatitis B virus infection Dosing and enrollment of participants in phase IIb Catalyst trials, along with ongoing studies of drug in chronic HBV, halted due to evidence of hepatocellular dysfunction and elevated alanine transaminase in 3 participants that was potentially consistent with liver injury
Phase III
Iterum Therapeutics plc, of Dublin Sulopenem Broad-spectrum penem beta-lactam antibiotic Urinary tract infection Fully enrolled Sure 1 trial in uncomplicated UTIs; top-line data expected in first quarter of 2020

Notes

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

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