Company Product Description Indication Status
Phase I
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion Stem cell antigen-1 inhibitor COVID-19 infection First of about 10 participants dosed in U.S. trial evaluating 5-day I.V. formulation in infected adults who require supplemental oxygen; primary endpoint is safety and tolerability
Aravive Inc., of Houston AVB-500 Growth arrest specific protein 6 ligand inhibitor Platinum-resistant ovarian cancer Phase Ib combination trial with paclitaxel or pegylated liposomal doxorubicin in in 53 participants identified 15 mg/kg as recommended phase II dose; at that dose in 5 of 6 evaluable participants, 1 showed complete response that continues after 3 months on AVB-500 as single agent, with 2 partial responses and 2 with stable disease
Clarity Pharmaceuticals Ltd., of Sydney 67Cu-Sartate Peptide receptor radionuclide therapy Neuroblastoma Enrollment opened in phase I/IIa trial in pediatric patients with high-risk disease
Pipeline Therapeutics Inc., of San Diego PIPE-505 Small-molecule gamma secretase inhibitor Sensorineural hearing loss Started phase I/IIa trial in SNHL associated with hearing speech in noisy environments; 24 adults to be enrolled; top-line data expected in early 2021
Quadriga Biosciences Inc., of Los Altos, Calif. QBS-10072S L-type amino acid transporter 1 modulator Metastatic cancer First participant dosed in study assessing maximum tolerated dose, pharmacokinetics and preliminary antitumor activity; expansion cohorts with brain metastases and astrocytoma will be enrolled at maximally tolerated or biologically relevant dose
Phase II
Acurx Pharmaceuticals LLC, of White Plains, N.Y. Ibezapolstat DNA polymerase III inhibitor Clostridium difficile infection In open-label 2A segment of trial enrolling up to 20 participants, first 6 met primary endpoint of clinical cure at end of treatment; randomized 2B segment will evaluate clinical cure and sustained clinical cure, safety and pharmacokinetics vs. vancomycin in about 64 additional participants
Corcept Therapeutics Inc., of Menlo Park, Calif. Relacorilant Glucocorticoid receptor antagonist Ovarian cancer Combination trial with nab-paclitaxel completed enrollment with 177 participants; top-line data expected in first half of 2021
Phase III
Genfit SA, of Lille, France Elafibranor  Dual PPAR-alpha/delta agonist Nonalcoholic steatohepatitis with fibrosis Resolve-It trial discontinued; interim analysis in May concluded trial missed predefined primary surrogate efficacy endpoint of NASH resolution without worsening of fibrosis; elafibranor still expected to advance into phase III in primary biliary cholangitis
Incyte Corp., of Wilmington, Del. Jakafi (ruxolitinib)  JAK1/JAK2 inhibitor Graft-vs.-host disease Reach3 trial in individuals with chronic disease met primary endpoint of superior overall response at week 24 vs. best available therapy and met both key secondary endpoints

Notes

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