Human Trials

Faron Pharmaceuticals reports inconsistent Traumakine biomarker results

Faron Pharmaceuticals has announced preliminary biomarker data from its Phase III INTEREST trial of Traumakine for the treatment of Acute Respiratory Distress Syndrome (ARDS).

ViiV’s dolutegravir/lamivudine regimen succeeds in two phase 3 HIV-1 trials

ViiV Healthcare reported that two phase 3 trials evaluating the two-drug regimen (2DR) of dolutegravir (Tivicay) and lamivudine (Epivir) in treatment naïve HIV-1 infected adults demonstrated the ability to control HIV.

Flex Pharma to stop two neuromuscular disease trials over safety concerns

Flex Pharma said that it is scrapping two ongoing phase 2 neuromuscular disease trials, evaluating its lead drug candidate FLX-787, due to safety concerns.

Grünenthal begins phase III trials in Complex Regional Pain Syndrome

Grünenthal has recruited first patients in two trials of pivotal phase III program to investigate neridronate for the treatment of Complex Regional Pain Syndrome (CRPS).

FDA accepts Cellenkos’ IND to begin clinical trial of CK0801 for bone marrow failure syndromes

The US Food and Drug Administration (FDA) has cleared Cellenkos’ investigational new drug (IND) application to proceed with a phase I clinical trial of CK0801, third party cord blood derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis.

Alnylam’s Lumasiran yields positive results in phase 1/2 Hyperoxaluria study

Alnylam Pharmaceuticals said that lumasiran, its investigational RNAi therapeutic targeting glycolate oxidase (GO) has yielded positive results from a phase 1/2 study in patients with Primary Hyperoxaluria Type 1 (PH1).

AbbVie’s upadacitinib succeeds in phase 3 trial in rheumatoid arthritis

AbbVie said that the phase 3 SELECT-EARLY trial evaluating two doses of upadacitinib (15 mg and 30 mg) as monotherapy in the treatment of rheumatoid arthritis met the primary endpoints of ACR50a at week 12 and clinical remissionb at week 24 versus methotrexate (MTX).

AstraZeneca says Lynparza/abiraterone combo delayed disease progression in mCRPC

AstraZeneca has reported that Lynparza (olaparib) in combination with abiraterone succeeded in a phase II trial by delaying disease progression in metastatic castration-resistant prostate cancer (mCRPC) patients.

Novartis phase III trial shows Kisqali combo therapy improves PFS in HR+/HER2- advanced breast cancer

Novartis has reported positive results from the third Phase III trial of Kisqali (ribociclib) in advanced or metastatic breast cancer.