Company Product Description Indication Status
Phase I
Cabaletta Bio Inc., of Philadelphia DSG3-CAART  Desmoglein 3 chimeric autoantibody receptor T cells Mucosal pemphigus vulgaris  Anticipates a delay in reporting the acute safety data from the first cohort in DesCAARTes trial due to COVID-19 pandemic
Cohbar Inc., of Menlo Park, Calif. CB4-211 Mitochondria-based therapeutic Nonalcoholic steatohepatitis Anticipating delays in the completion of the CB4-211 phase Ib study as a result of a pause by some CRO partners in response to the COVID-19 pandemic 
Faron Pharmaceuticals Oy, of Turku, Finland Clevegen Precision cancer immunotherapy targeting Clever-1-positive tumor-associated macrophages Metastatic or inoperable solid tumors Data monitoring committee advised to continue study as planned
Intensity Therapeutics Inc., of Westport, Conn. INT230-6 Cisplatin and vinblastine plus penetration enhancer molecule Triple-negative breast cancer, Merkel cell carcinoma, chordoma, desmoid tumor and soft tissue sarcoma Safety profile when given with Keytruda (pembrolizumab, Merck & Co. Inc.) appears similar to monotherapy
Pluristem Therapeutics Inc., of Haifa, Israel PLX cells Allogeneic mesenchymal-like cells COVID-19 Dosed 3 more patients in 2 different hospitals in Israel under a compassionate use program
Synlogic Inc., of Cambridge, Mass. SYNB-1618 Synthetic Biotic medicine designed to consume phenylalanine in the gastrointestinal tract Phenylketonuria Enrollment likely slower due to COVID-19 outbreak
Tcr2 Therapeutics Inc., of Cambridge, Mass. TC-110 TRuC-T cell candidate targeting CD19 Hematological malignancy  Trial started
Phase II
Aveo Oncology Inc., of Cambridge, Mass. Ficlatuzumab Hepatocyte growth factor inhibitory antibody  Relapsed/refractory acute myeloid leukemia CyFi-2 study discontinued due to COVID-19 pandemic
Cytodyn Inc., of Vancouver, Wash. Leronlimab CCR5 antagonist COVID-19 3 more patients treated, bringing total to 10
Immunovant Inc., of New York IMVT-1401 Fully human monoclonal antibody targeting the neonatal Fc receptor Thyroid eye disease 65% mean reduction in total IgG was observed from baseline to end of treatment, with a pharmacodynamic response nearly identical to modeled predictions for dosing regimen tested in trial
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa. VGX-3100 DNA medicine that works by stimulating a specific immune response to HPV-16 and HPV-18 Anal dysplasia Cleared high-risk HPV 16/18-associated precancerous lesions in 50% of patients, and reduced the number of lesions in 75% of patients
Mediwound Ltd., of Yavne, Israel Escharex Topical enzyme proteolytic therapy Venous leg ulcers Enrollment suspended due to COVID-19 outbreak
Opthea Ltd., of Melbourne, Australia OPT-302 Blocks activity of VEGF-C and VEGF-D Diabetic macular edema Completed patient dosing and week 12 visits in the study testing OPT-302 plus Eylea (aflibercept, Regeneron Pharmaceuticals Inc.)
Ovid Therapeutics Inc., of New York Soticlestat (OV-935/TAK-935) Cholesterol 24-hydroxylase inhibitor CDKL5 deficiency disorder and Dup15q syndrome Of the 5 patients with CDKL5 deficiency disorder, 3 patients had 45%, 61% and 63% fewer motor seizures during the maintenance phase; of the 6 patients with Dup15q syndrome, the 1 patient with pure motor seizures saw a 90% reduction in seizure frequency during the maintenance phase; of the other 5 Dup15q patients with mixed seizure types, 3 patients with myoclonic seizures showed a 60%, 66% and 100% reduction over the maintenance period and 2 patients had absence seizures and showed a 78% and 74% reduction during the maintenance phase
Phasebio Pharmaceuticals Inc., of Malvern, Pa. PB-1046 Sustained-release vasoactive intestinal peptide analogue Pulmonary arterial hypertension Pausing enrollment in study due to COVID-19
Revive Therapeutics Ltd., of Toronto Bucillamine   Antioxidant  COVID-19 Plans to run a clinical trial testing the drug in the U.S. and in Asia-Pacific countries
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Kevzara (sarilumab) Monoclonal antibody targeting interlukin-6 COVID-19 First patient treated in an ex-U.S. phase II/III trial
Synlogic Inc., of Cambridge, Mass. SYNB-1618 Synthetic biotic that consumes phenylalanine  Phenylketonuria  Enrollment expected to be delayed due to COVID-19
Zealand Pharma A/S, of Copenhagen Dasiglucagon  Glucagon analogue Hypoglycemia after gastric bypass bariatric surgery Patients receiving 80 μg and 200 μg dasiglucagon spent an average of 27.5 minutes and 14 minutes in post-meal hypoglycemia (plasma glucose <3.9 mmol/L), compared to 62 minutes for placebo (p<0.05 vs. placebo for both)
Seres Therapeutics Inc., of Cambridge, Mass. SER-287 Ecobiotic (encapsulated purified suspension of eubacterial spores) Ulcerative colitis Phase IIb study about 60% enrolled based on 201-patient target size but development adversely affected by clinical sites halting non-essential procedures, including endoscopies, due to COVID-19; trial may not achieve original enrollment target in second half of 2020
Phase III
Astrazeneca plc, of Cambridge, U.K. Farxiga (dapagliflozin) SGLT2 inhibitor Chronic kidney disease DAPA-CKD study will be stopped early following a recommendation from an independent data monitoring committee due to overwhelming efficacy; data to be presented in a forthcoming medical meeting
Axsome Therapeutics Inc., of New York AXS-05  NMDA receptor antagonist Treatment-resistant depression  In the Stride-1 study, AXS-05 produced a mean reduction of 11.6 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6 (primary endpoint) compared to a 9.4-point reduction for patients taking bupropion (p=0.117); study met secondary endpoint MADRS score over the entire 6-week treatment period with mean reductions of 8.6 for AXS-05 vs. 6.7 for bupropion (p=0.031)
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Rimegepant  CGRP receptor antagonist Migraine prevention Rimegepant produced a reduction of 4.5 days with migraines per month, compared to a 3.7-day reduction for placebo (p=0.0176); in patients not taking concomitant preventive treatment reduction was 4.9 days and 3.7 days for rimegepant and placebo, respectively (p=0.0020); 48% of patients taking rimegepant had at least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month compared to 41% of patients taking placebo
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson A3 adenosine receptor agonist  Moderate to severe plaque psoriasis Implementing an interim analysis of the Comfort study; data expected in the fourth quarter of 2020
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., and Symbio Pharmaceuticals Ltd., of Tokyo Treakisym (bendamustine)  PARP modulator  Low-grade non-Hodgkin lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia Completed enrollment in Japanese study testing a 10-minute rapid infusion of the drug
Oyster Point Pharma Inc., of Princeton, N.J. OC-01 Nicotinic acetylcholine receptor agonist Dry eye disease Completed enrollment of 758 patients in the Onset-2 study; data expected by the end of the second quarter of 2020; day 28 data impacted by COVID-19, which is predicted to reduce power for primary endpoint to 99%
Polyphor AG, of Allschwil, Switzerland Balixafortide CXCR4 chemokine antagonist Breast cancer Following first prespecified interim safety analysis on first 193 randomized participants with HER2-negative, locally recurrent or metastatic disease, independent data safety monitoring board recommended pivotal study continue without modifications
Resverlogix Corp., of Calgary, Alberta Apabetalone Bromodomain containing protein inhibitor Acute coronary syndrome BETonMACE study, reported in Journal of the American Medical Association, did not reach significance in primary outcome measure but showed trend toward reduction in MACE vs. placebo (10.3% vs. 12.4%, respectively) in those with type 2 diabetes with acute coronary syndrome and low HDL cholesterol; clinically significant reductions in primary endpoint observed in prespecified subgroups, including those with baseline estimated glomerular flow rate of <60 mL/min/1.73 m2
Seres Therapeutics Inc., of Cambridge, Mass. SER-109 Ecobiotic (encapsulated mixture of bacterial spores from fecal microbiota) Clostridium difficile infection Completed enrollment of Ecospor III trial at 181 individuals with recurrent disease; enrollment halted prior to expected 188 participants due to COVID-19 pandemic; top-line results expected in mid-2020

Notes

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