Phase I

Cellect Biotechnology Ltd., of Tel Aviv, Israel


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


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.


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


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


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.


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


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

No Comments