Company

Product

Description

Indication

Status

Phase I

Enlivex Therapeutics Ltd., of Nes Ziona, Israel

OTS Allocetra

Off-the-shelf immunotherapy

Severe sepsis

After reviewing the first 2 cohorts of 6 total patients in phase Ib trial, the safety review committee recommended enrolling the last cohort of 4 patients; drug was well-tolerated when used with standard-of-care treatment and all patients recovered from their severe sepsis

Redx Pharma plc, of Cheshire, U.K.

RXC-004

Porcupine inhibitor

Advanced malignancies

First patient treated; enrollment has begun for second cohort; data expected in 2020

Phase II

Alkahest Inc., of San Carlos, Calif.

GRF-6021

Plasma fractions

Primary hip or knee arthroplasty

Treated first of about 45 patients in the AKST6021-211 study assessing post-surgery recovery and immunological profile at various timepoints

Eton Pharmaceuticals Inc., of Deer Park, Ill.

ET-104

Liquid formulation of an undisclosed FDA-approved drug used to treat a severe neurological condition

Healthy subjects

In a bioequivalence study, ET-104 demonstrated pharmacokinetic equivalence to an FDA-approved oral solid product with the same active ingredient; plans to file an NDA in fourth quarter of 2019

Fulcrum Therapeutics Inc., of Cambridge, Mass.

Losmapimod

P38alpha/beta mitogen activated protein kinase inhibitor

Facioscapulohumeral muscular dystrophy

Started phase IIb ReDUX4 study testing the ability of losmapimod to reduce DUX4-driven gene expression over 24 weeks; data expected in third quarter of 2020

Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa.

VGX-3100

DNA-based immunotherapy

HPV-related precancerous lesions of the anus

Completed enrollment in the 24-patient study; preliminary efficacy and safety data expected in the fourth quarter of 2019

Kalytera Therapeutics Inc., of San Francisco

Cannabidiol

Cannabinoid

Acute graft-vs.-host disease

1 of 12 patients in the low-dose cohort and none of the patients in the medium-dose cohort developed grades 2-4 acute GVHD; high-dose cohort won't be started; plans to run a phase III study

Knopp Biosciences LLC, of Pittsburgh

Dexpramipexole

Affects eosinophil maturation in bone marrow

Moderate to severe eosinophilic asthma

Started study testing 3 doses of the drug in about 100 patients; primary endpoint is change in blood absolute eosinophil count from baseline to week 12; secondary endpoints include changes in pre-bronchodilator FEV1 and asthma control outcomes (ACQ-7 questionnaire) from baseline to week 12; data expected in second half of 2020

On Target Laboratories Inc., of West Lafayette, Ind.

OTL-38

Folate receptor-targeting ligand linked to near-infrared dye

Lung cancer

Completed study for detection of lung cancer nodules in patients during surgery; top-line data expected in first half of 2020

Phase III

Vascular Therapies Inc., of Cresskill, N.J.

Sirolimus

Formulation for intraoperative local, perivascular drug delivery

Kidney disease

Completed enrollment in U.S. Access trial; testing formulation to improve outcomes in patients undergoing surgical creation of an arteriovenous fistula to provide vascular access for hemodialysis; primary endpoint is Fistula Suitability for Dialysis at 6 months, and results are expected in the second quarter of 2020


Notes

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