Company

Product

Description

Indication

Status

Phase I

Cellect Biotechnology Ltd., of Tel Aviv, Israel

Apograft

Stem cells

Blood cancer disorders undergoing allogenic HLA-matched hematopoietic stem cell transplant

After reviewing data from the 9th patient in the phase I/II study, the data and safety monitoring board recommended dose escalation; patient recruitment expected to be complete by the end of 2019 with data in the first half of 2020

Phase II

Immunic Inc., of San Diego

IMU-838

Blocks dihydroorotate dehydrogenase

Primary sclerosing cholangitis

Enrolled first of 30 patients in an investigator-sponsored study; primary endpoint is the change in serum alkaline phosphatase at 6 months compared to baseline

Mallinckrodt plc, of Staines-Upon-Thames, U.K.

MNK-6106

Ammonia scavenger

Hepatic cirrhosis and hepatic encephalopathy

First of about 48 patients enrolled in a phase IIa study measuring changes in plasma ammonia concentration for 3 dosing regimens of MNK-6106 compared to rifaximin

Polypid Ltd., of Petah Tikva, Israel

D-PLEX100

Extended-release, broad-spectrum antibiotic

Prevention of postabdominal surgery incisional site infections

Completed enrollment in study measuring incisional infection over 30 days; data expected in October 2019

Phase III

Kedrion Biopharma Inc., of Fort Lee, N.J.

10% intravenous immuno-globulin

Antibodies

Primary immunodeficiency diseases

Enrolled first of about 50 patients in the Cares10 study that is expected to be completed by mid-2021

Novavax Inc., of Gaithersburg, Md.

Resvax

Aluminum adjuvanted respiratory syncytial virus fusion protein nanoparticle vaccine

RSV infection prophylaxis

New data from the Prepare study showed the vaccine produced a 59.6% reduction in the incidence of serious adverse events diagnosed as pneumonia, with confirmation by chest x-ray, which extended through the first year of life; in x-ray-confirmed pneumonia associated with detection of RSV, efficacy was 72.9% through 180 days of life


Notes

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

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