Company Product Description Indication Status
Phase I
Cyclo Therapeutics Inc., of Gainesville, Fla. Trappsol Cyclo Cholesterol binding agent Niemann Pick disease type C Safety review committee determined that study drug has acceptable safety profile; top-line data expected in May 2020 
Forty Seven Inc., of Menlo Park, Calif. FSI-174 cKIT tyrosine kinase inhibitor Hematologic cancer Start of trial in healthy volunteers delayed due to COVID-19
Pliant Therapeutics Inc., of South San Francisco PLN-1474 Integrin alpha-V/beta-1 antagonist Nonalcoholic steatohepatitis First cohort of healthy participants dosed in dose-escalation trial in program partnered with Novartis AG
Phase II
Irlab Therapeutics AB, of Stockholm IRL-752 5-HT 7 receptor antagonist; alpha adrenoceptor antagonist Parkinson's disease Results of phase IIa study, published in Movement Disorders, show potential for study drug to improve balance and reduce fall risk by increasing levels of norepinephrine and dopamine in frontal cortex and activating genes involved in nerve cell connections
Obseva SA, of Geneva OBE-022 PGF2 alpha antagonist Premature labor Data from phase IIa Prolong trial expected to report in second half of 2020, as planned
Vaccitech Ltd., of Oxford, U.K. VTP-800 Recombinant virus-based vaccine Prostate cancer In phase IIa Advance combination study with anti-PD-1 in 23 men with metastatic castration-resistant disease, 5 (22%) had > 50% reduction in PSA level at any timepoint compared to baseline (median of 88 ng/ml); 4 of these maintained that response when tested 3 weeks later; 1 with response had PSA level of 0 at 24 weeks
Phase III
Cytodyn Inc., of Vancouver, Wash. Leronlimab CCR5 antagonist COVID-19 2 additional individuals treated for respiratory complications at undisclosed New York hospital under emergency IND from FDA, bringing total treated to 4
Humanigen Inc., of Burlingame, Calif. Lenzilumab GM-CSF ligand inhibitor COVID-19 Company seeking to advance development for prevention and treatment of cytokine storm that can lead to acute respiratory distress syndrome associated with SARS-CoV-2 infection; trials expected to begin upon approval by regulatory authorities; company also plans to make study drug available on compassionate use basis
Novan Inc., of Morrisville, N.C. SB-206 (berdazimer sodium) Nitric oxide-releasing macromolecule Molluscum contagiosum infection Safety evaluation of B-Simple program through week 24 showed treatment-emergent adverse events (TEAEs) reported in > 5% of those in treated groups were application site pain and/or erythema; most TEAEs were mild or moderate, and all study drug discontinuations in treatment arm were due to application site reactions; no treatment-related SAEs reported across both studies; type C teleconference with FDA remains scheduled for April 1, 2020
Obseva SA, of Geneva Linzagolix GNRH receptor antagonist Uterine fibroids Results from fully enrolled Primrose 1 and 2 trials remain on track to report in second quarter of 2020
Obseva SA, of Geneva Linzagolix GNRH receptor antagonist Endometriosis Screening and randomization in ongoing Edelweiss 2 and 3 trials placed on voluntary hold due to COVID-19; study sites continue to manage enrolled participants
Roche Holding AG, of Basel, Switzerland Venclexta/Venclyxto (venetoclax)  BCL-2 protein inhibitor Acute myeloid leukemia Viale-A combination study with hypomethylating agent azacitidine showed statistically significant improvement in overall survival in those with previously untreated disease who were ineligible for intensive induction chemotherapy vs. azacitidine alone; details expected to report at undisclosed medical meeting

Notes

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

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