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LONDON (Alliance News) - GlaxoSmithKline PLC on Monday said the results from a phase 3 study of daprodustat in Japanese patients with anaemia showed positive results.
The pharmaceutical company said the study was conducted to evaluate the daprodustat drug as a potential treatment for anaemia associated with chronic kidney disease.
Results from the 52-week study of 271 haemodialysis-dependent patients, showed that oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection, as measured by mean change from baseline in hemoglobin levels over weeks 40 to 52.
Results from this study are part of the ongoing phase 3 programme being conducted in Japan to support submission to the Japanese Ministry of Health, Labour & Welfare in 2019.
"Anaemia is common in patients with chronic kidney disease and can result in symptoms such as weakness and fatigue," explained Chief Scientific Officer Hal Barron.
"The promising data generated from this study is an important step in the development of daprodustat as a potential oral treatment option for these patients," added Barron.
In a separate statement, GlaxoSmithKline said its ViiV Healthcare has presented three-year results from a phase IIb study investigating a long-acting, two-drug, injectable regimen of cabotegravir and rilpivirine.
ViiV Healthcare is a joint venture between American pharmaceutical firm Pfizer Inc and GlaxoSmithKline, created in November 2009.
Cabotegravir is an investigational integrase inhibitor, developed by ViiV Healthcare, and is not approved by regulatory authorities anywhere in the world. Meanwhile, rilpivirine is a once daily non-nucleoside reverse transcriptase inhibitor used for the treatment of human immunodeficiency virus.
At 160 weeks, the long-acting regimen demonstrated high rates of virologic response, long-term durability of virologic response and good overall tolerability.
"Our two-drug regimen research efforts explore a number of treatment options that look beyond viral load and focus on addressing the unresolved issues that many people living with HIV face," explained ViiV Healthcare Chief Scientific & Medical Officer John Pottage.
"The three-year data show cabotegravir and rilpivirine as a long-acting injectable regimen may provide an alternative to daily pills, reducing the number of annual doses from 365 to 12. It is encouraging to see these long-term results," added Pottage.
ViiV Healthcare presented the study results of cabotegravir and rilpivirine at the HIV Glasgow Drug Therapy meeting in Scotland.
GlaxoSmithKline shares were trading 1.1% higher on Monday at 1,525.20 pence each.
