A few companies shared some big Phase III results this week. Here’s a look.
A few companies shared some big Phase III results this week. Here’s a look.
CanSino’s COVID-19 Trial Continues
CanSino Biologics received positive top-line interim safety and efficacy news on its Phase III for its one-dose COVID-19 vaccine, topping a raft of upbeat late-stage news from Global Blood Therapeutics, Travere Therapeutics and NeurMedix.
CanSino will complete the Phase III trial for its human adenovirus 5-based COVID-19 vaccine after getting positive top-line interim data with no serious adverse events from an independent review, according to Chinese media reports. The vaccine, Ad5-nCoV, has been tested in 40,000 across clinical sites in Russia, Mexico, Pakistan, Argentina and Chile. The company expects to receive complete interim results this week.
Efficacy data has not yet been released, but CanSino announced in November it had sold 35 million doses to Mexico. Ad5-bCoV was developed in conjunction with the Beijing Institute of Biotechnology (BIB), part of China’s Academy of Military Medical Sciences. Phase II data was published in The Lancet in July.
High-Dose Oxbryta Improves Leg Ulcers in Sickle Cell Patients Tested
A post-hoc study of Phase III results showed high doses of Oxbryta improved or resolved leg ulcers in 13 out of 14 sickle cell disease patients receiving 900 mg or 1500 mg after 72 weeks, compared with 63% in a placebo group. The findings were published last week by Global Blood Therapeutics and its academic collaborators in American Journal of Hematology.
By some estimates, leg ulcers occur in 14-18% of sickle cell disease patients, particularly in patients with severe hemolytic anemia. Oxbryta was approved in the U.S. in 2019 to treat sickle cell disease in patients 12 or older, and is currently in Phase III testing in children as young as 2. Global Blood Therapeutics is seeking European Medicines Agency (EMA) approval to market Oxbryta for hemolytic anemia in sickle cell disease in patients and last week the EMA completed its review. The European Commission will announce an approval decision by early April.
Sparsentan Hits Endpoint in Focal Segmental Glomerulosclerosis Trial
A Phase III study of patients taking sparsentan for the kidney scarring disease focal segmental glomerulosclerosis showed a statistically significant partial response at 36 weeks, according to a statement by Travere Therapeutics. There are no approved therapies for focal segmental glomerulosclerosis, a progressive disorder which can lead to end-stage kidney disease.
Based on the data, Travere aims to work with regulators to determine the next steps. Upon completion of the current Phase III DUPLEX study, the primary endpoint will be estimated glomerular filtration rate, a measure of kidney function, for the 371 enrolled patients over 108 weeks of treatment. Patients are receiving either sparsentan or an active control, irbesartan.
NeurMedix to Launch Alzheimer’s Phase III Trial in May
NeurMedix will launch a Phase III trial of its insulin-sensitizing small molecule NE3107 in Alzheimer’s disease patients in May, following U.S. Food and Drug Administration’s (FDA) authorization this week. The therapeutic approach has been developed after a growing body of evidence has linked the neurological disease with insulin-resistant type 2 diabetes. Novo Nordisk previously launched a Phase IIb clinical trial of its diabetes drug Victoza for Alzheimer’s disease.
