All articles by Bikrant Kumar Singh

Bikrant Kumar Singh

August’s top news stories

Biopharmaceutical firm Retrophin reported that the Phase III clinical trial of fosmetpantotenate failed to meet endpoints in pantothenate kinase-associated neurodegeneration (PKAN) patients; and MyoKardia has commenced dosing of patients in a Phase I trial of small molecule MYK-224 for the treatment of hypertrophic cardiomyopathy (HCM). Clinicaltrialsarena.com wraps up the key headlines from August 2019.

Translate Bio’s mRNA candidate produces mixed results in CF trial

Translate Bio has reported positive interim data from a Phase I/II clinical trial of its mRNA candidate MRT5005 for the treatment of cystic fibrosis (CF) patients.

Daiichi Sankyo reports positive data from hypercholesterolemia study

Daiichi Sankyo has reported findings from the Phase III clinical trial of bempedoic acid / ezetimibe fixed-dose combination (FDC) tablet in hypercholesterolemia patients.

Lilly reports improved survival in Verzenio’s MONARCH 2 trial

Eli Lilly has reported positive findings from the Phase III MONARCH 2 clinical trial of Verzenio (abemaciclib) with fulvestrant to treat advanced or metastatic breast cancer.

Alkermes-Biogen’s MS drug shows improved GI tolerability

Alkermes and Biogen have reported that diroximel fumarate demonstrated a statistically superior gastrointestinal (GI) tolerability profile compared to Tecfidera (dimethyl fumarate) in a Phase III EVOLVE-MS-2 study for relapsing-remitting multiple sclerosis (RRMS).

Cidara reports positive data from Phase II trial of rezafungin

Cidara Therapeutics has announced that its antifungal candidate rezafungin met all efficacy, safety, and tolerability measures in part B of Phase II STRIVE (STRIVE B) clinical trial involving candidemia and/or invasive candidiasis patients.

Bellus Health starts recruitment in Phase II chronic cough trial

Canadian biopharmaceutical firm Bellus Health has commenced patient enrolment in the Phase II RELIEF clinical trial of BLU-5937 to treat refractory chronic cough.

Keytruda improves response in late-stage breast cancer study

Merck has reported positive results from the Phase III KEYNOTE-522 clinical trial of Keytruda in combination with chemotherapy for the treatment of triple-negative breast cancer (TNBC).

Oryzon closes enrolment in vafidemstat’s Phase IIa trials

Spain-based Oryzon Genomics has completed patient enrolment in the Phase IIa REIMAGINE and REIMAGINE-AD clinical trials of vafidemstat.

PARAGON-HF study by Novartis misses primary goal

Novartis has reported that the Phase III PARAGON-HF clinical trial of sacubitril/valsartan for heart failure patients with preserved ejection fraction (HFpEF) has failed to meet the primary endpoint.