Company Product Description Indication Status
Phase I
Artelo Biosciences Inc., of La Jolla, Calif. ART27.13 Peripherally restricted, synthetic, dual cannabinoid agonist Cancer anorexia and weight loss Received ethics committee approval in U.K. for phase I/II Cares trial; enrollment set to start this year
Forte Biosciences Inc., of Torrance, Calif. FB-401 Topically applied live biotherapeutic consisting of strains of Roseomonas mucosa  Atopic dermatitis Dosed first of about 124 pediatric, adolescent and adult subjects, 2 and older; primary endpoint is EASI-50
Inversago Pharma Inc., of Montreal INV-101 Peripherally acting CB1 blocker Prader-Willi syndrome and nonalcoholic steatohepatitis Started study to enroll healthy participants in Canada, ages 18 to 55
Johnson & Johnson, of New Brunswick, N.J. JNJ-78436735 (Ad26.COV2.S) Vaccine COVID-19 Interim analysis from phase I/IIa study, published on medRxiv, showed single dose induced a strong neutralizing antibody response in nearly all participants, 18 and older, and was generally well-tolerated; immune responses were similar across the age groups studied, including older adults; the single dose of 5x1010 virus particles was selected for further evaluation in phase III Ensemble trial
Kaleido Biosciences Inc., of Lexington, Mass. KB-295 Microbiome metabolic therapy Mild to moderate ulcerative colitis Dosed first patient; top-line data expected in mid-2021
Kuur Therapeutics Inc., of Houston KUR-502 Allogeneic CAR-NKT therapy Hematological malignancies Treated first patient in Anchor study; enrolling patients with relapse/refractory CD19+ malignancies, including B-cell lymphomas, acute lymphoblastic leukemia and chronic lymphocytic leukemia 
Medincell SA, of Montpellier, France Ivermectin  Small molecule COVID-19 First patient administered in study testing oral form over 4 weeks to simulate continuous release of the active ingredient by long-acting injectable
Veru Inc., of Miami VERU-111 Dual alpha/beta tubulin inhibitor Prostate cancer Fully enrolled phase II portion (n=40) of phase Ib/II study at recommended dose of 63 mg/day in men with metastatic castration-resistant disease resistant to at least 1 androgen receptor-targeting agent but prior to I.V. chemotherapy; key efficacy endpoint is radiographic imaging of progression-free survival
Zucara Therapeutics Inc., of Toronto ZT-01 Inhibits somatostatin Insulin-induced hypoglycemia Dosed first subject; single ascending-dose portion will enroll 40 healthy volunteers, followed by multiple ascending-dose portion to involve 24 subjects with type 1 diabetes
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor epsilon 2 subunit inhibitor COVID-19 infection Phase IIb study achieved two-thirds of enrollment target, with 100 participants; study expected to complete in November 2020 with data readout before year-end 2020
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-154 (topical roflumilast foam)  PDE4 inhibitor Seborrheic dermatitis 0.3% dose administered once daily for 8 weeks achieved statistical significance on primary endpoint of Investigator Global Assessment success rate, at 73.8% vs. 40.9% for vehicle (p<0.0001), in moderate to severe disease
Ascendis Pharma A/S, of Copenhagen Transcon PTH Parathyroid hormone prodrug Adult hypoparathyroidism 6-month data from open-label extension of Path Forward trial showed 91% of participants eliminated standard of care; 86% normalized or reduced by 50% 24-hour urine calcium; 71% achieved response on composite endpoint of serum calcium in the normal range, independence from active vitamin D, taking ≤500 mg/day of calcium supplements and 24-hour urine calcium in normal range or 50% reduction from baseline, including 74% randomized to study drug 
Basilea Pharmaceutica Ltd., of Basel, Switzerland Lisavanbulin Tubulin binding agent Glioblastoma Expansion study initiated in people with recurrent disease whose tumor tested positive for potential response-predictive biomarker end-binding protein 1
Beyondspring Inc., of New York Plinabulin Differentiated immune and stem cell modulator Neutropenia Data from Protective-1 study in chemotherapy-induced disease, published in JAMA Oncology, showed study drug as single agent was equally effective as pegfilgrastim to prevent grade 4 neutropenia and infections; those who received plinabulin maintained overall quality of life (p<0.001) and experienced less bone pain and thrombocytopenia vs. those on pegfilgrastim
Concert Pharmaceuticals Inc., of Lexington, Mass. CTP-692 (deuterated D-serine) NMDA receptor agonist Schizophrenia Trial fully enrolled; top-line data expected in first quarter of 2021
Ocular Therapeutix Inc., of Bedford, Mass. OTX-CSI (cyclosporine intracanalicular insert)
Calcineurin inhibitor
Dry eye disease First of about 105 participants dosed in 16-week trial evaluating 2 formulations with vehicle insert
Phase III
Citius Pharmaceuticals Inc., of Cranford, N.J. Mino-Lok Antibiotic lock solution Catheter-related bloodstream infections Data monitoring committee recommended continuing trial without modifications and requested ad hoc meeting
Myovant Sciences Ltd., of Basel, Switzerland Relugolix GNRH receptor antagonist Prostate cancer In Hero study, relugolix had similar rate as comparator leuprolide acetate (74% vs. 75%, respectively) in secondary endpoint of castration resistance-free survival, missing statistical superiority (p=0.84)
Revive Therapeutics Ltd., of Toronto Bucillamine Xanthine oxidase inhibitor Mild to moderate COVID-19  Agreements finalized with 5 U.S. sites and near completion with 10 additional U.S. sites for confirmatory trial; enrollment of up to 1,000 participants expected to begin in October 2020
Shanghai Junshi Biosciences Co. Ltd., of Shanghai Toripalimab PD-1 inhibitor Nasopharyngeal carcinoma At interim analysis, independent data monitoring committee concluded that Jupiter-02 combination trial with gemcitabine/cisplatin met primary endpoint of progression-free survival as first-line therapy in recurrent or metastatic disease

Notes

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