Company Product Description Indication Status
Phase I
Aduro Biotech Inc., of Berkeley, Calif. BION-1301 Antibody targeting A Proliferation Inducing Ligand IgA nephropathy Well-tolerated, with no severe adverse events, treatment discontinuations or events meeting stopping criteria, across a wide range of doses
Ameri Holdings Inc., of Atlanta Cannabidiol formulation Cannabidiol Glioblastoma multiforme Proposed amalgamation partner Jay Pharma Inc. received institutional review board approval for trial by Rabin Medical Center in Petah Tikva, Israel 
Innovent Biologics Inc., of Suzhou, China IBI-318 Anti-PD-1/PD-L1 bispecific antibody Advanced tumors Of the 9 patients who received a dose of 10 mg or greater, 3 had an objective response
Moleculin Biotech Inc., of Houston WP-1066 Immune/transcription modulator Brain tumors Enrolled first patient in the study
Phase II
Asana Biosciences LLC, of Lawrenceville, N.J. Gusacitinib (ASN-002) Janus kinase and spleen tyrosine kinase inhibitor Moderate to severe chronic hand eczema Gusacitinib 80 mg produced a 69% decrease from baseline to week 16 in mean modified total lesion severity score (mTLSS), compared to a 49% decrease for 40 mg and 33% decrease for placebo (p<0.005 for 80-mg dose); 40-mg and 80-mg doses produced a 50% and 66% improvement, respectively, in the mTLSS pruritus subscore at week 16
Bergenbio ASA, of Bergen, Norway Bemcentinib AXL inhibitor  Hospitalized COVID-19 First of 120 patients enrolled in the study; top-line data expected later in the summer
Beyondspring Inc., of New York Plinabulin Non-G-CSF small molecule Chemotherapy-induced neutropenia Data from Protective-2 study for CIN prevention in breast cancer patients receiving taxotere/doxorubicin/cyclophosphamide chemotherapy showed those who received low-dose Neulasta (pegfilgrastim) and plinabulin had comparable efficacy in terms of blood CD34+ counts but reported fewer cases of bone pain, myalgia and leukocytosis side effects vs. standard dose of Neulasta alone at 6 mg
Idera Pharmaceuticals Inc., of Exton, Pa. Tilsotolimod  Toll-like receptor 9 agonist Immunotherapy-naive micro-satellite stable colorectal cancer In the Illuminate-206 study, of the 10 patients treated with tilsotolimod plus Opdivo (nivolumab) and Yervoy (ipilimumab), 1 had stable disease; plans to enroll 10 more patients and increase frequency of Yervoy dosing
Menlo Therapeutics Inc., of Bridgewater, N.J. FCD-105 Bacteriostatic and anti-inflammatory minocycline plus the retinoid adapalene Moderate to severe acne vulgaris FCD-105 produced an Investigator’s Global Assessment of 0 or 1 and at least a 2-grade improvement from baseline to week 12 in 35.9% of patients compared to 15.7% of patients in the vehicle treatment group (p=0.0003); absolute reduction in inflammatory lesion counts at week 12 was -19.4 (-64.1%) for the FCD-105 and -15.58 (-50.9%) for the vehicle treatment group (p=0.0020)
Mirum Pharmaceuticals Inc., of Foster City, Calif. Maralixibat Apical sodium dependent bile acid transporter inhibitor Bile acid salt export pump deficiency At week 237, serum bile acid was reduced by 234.4 µmol/L from baseline (p<0.05); all 7 patients achieved serum bile acid control
Orphomed Inc., of San Francisco ORP-101 Opioid receptor kappa antagonist/mu partial agonist  Irritable bowel syndrome with diarrhea  Resuming patient recruitment, which was paused due to COVID-19
Relief Therapeutics AG, of  Zurich, Switzerland, and Neurorx Inc., of Miami RLF-100 Vasoactive intestinal polypeptide Acute respiratory distress syndrome in COVID-19 Treated first of 120 patients in phase IIb/III study; primary endpoints are mortality and index of respiratory distress
Santhera Pharmaceuticals Holding AG, of Pratteln, Switzerland Vamorolone Glucocorticoid receptor agonist; mineralocorticoid receptor antagonist; nuclear factor kappa B inhibitor Duchenne muscular dystrophy Partner Reveragen Biopharma Inc. completed open-label extension study of 24 months in boys who completed phase IIa Vision-DMD study (n=46); 66% chose treatment at highest tested dose (6 mg/kg/day) by end of extension study, and dosage was reported safe and well-tolerated
Tenax Therapeutics Inc., of Morrisville, N.C. Levosimendan Calcium sensitizer Pulmonary hypertension and heart failure with preserved ejection fraction Levosimendan reduced pulmonary capillary wedge pressure compared to baseline (p=<0.0017) and placebo (p=<0.0475) when the measurements at rest, with legs up, and on exercise were combined; drug also improved 6-minute walk distance compared to placebo (p=0.0329)
Phase III
Brainstorm Cell Therapeutics Inc., of New York Nurown Autologous MSC-NTF cells Amyotrophic lateral sclerosis Company continues to expect top-line data will be announced by the fourth quarter of 2020
Bristol Myers Squibb Co., of New York Zeposia (ozanimod) Sphingosine-1-phosphate receptor modulator Moderate to severe ulcerative colitis In the True North study, drug induced clinical remission at week 10 and maintained it at week 52 (p< 0.0001 for both); study also met secondary endpoints of clinical response and endoscopic improvement at week 10 and week 52
Nicox SA, of Sophia Antipolis, France NCX-470 Nitric oxide-donating bimatoprost analogue Open-angle glaucoma or ocular hypertension Enrolled first 12 patients in the study
Northwest Biotherapeutics Inc., of Bethesda, Md. Dcvax-L Dendritic cell-based vaccine Glioblastoma   COVID-19 has delayed final data collection; expected to be complete in mid-June 2020 or shortly thereafter
Regenerx Biopharmaceuticals Inc., of Rockville, Md. RGN-259  Thymosin beta 4 ligand  Dry eye syndrome Completion of the Arise-3 study expected to be delayed by approximately 2 months due to COVID-19
Sanofi SA, of Paris Sarclisa (isatuximab)  ADP ribosyl cyclase-1 inhibitor Multiple myeloma In Ikema trial, study drug added to standard-of-care carfilzomib (Kyprolis, Amgen Inc.) and dexamethasone reduced risk of disease progression or death by 47% (p=0.0007, n=179) vs. standard of care alone (n=123) in individuals with relapsed disease, with median progression-free survival not reached vs. 19.15 months, respectively, at preplanned interim analysis; Sarclisa also showed benefit across secondary endpoints
Satsuma Pharmaceuticals Inc., of South San Francisco STS-101 (dihydroergotamine nasal powder)  5-HT 1d receptor agonist Acute migraine Enrollment and randomization completed in pivotal Emerge trial; top-line results expected in second half of 2020


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

No Comments