Takeda announces trial based on blood of COVID-19 survivors could begin in July
Takeda Pharmaceutical Co. executives have said they plan to begin a clinical trial as early as July for a possible treatment for COVID-19 based on antibodies in the blood of coronavirus survivors.
The clinical trial would include hundreds of patients and could take months until completion. If proven a success, Takeda could file for approval by U.S. authorities this year, said Julie Kim, president of Takeda’s plasma-derived therapies unit.
“It’s still a bit unclear when the product will be available beyond the clinical study,” Kim said at an investor call on Wednesday. “But we do hope to see some information in terms of broader use before the end of the year.”
Fighting disease with blood from recovered patients is an ancient technique that has not been well tested for the novel coronavirus, which erupted late last year in China and has spread across the globe. Some hospitals are already collecting blood plasma from survivors and are combining it with people who are sick from the disease caused by the coronavirus, but its effectiveness is still being analysed.
According to a Reuters study, the newest coronavirus has infected 4.3 million people worldwide, and almost 300,000 have died. The pandemic has spurred multiple drugmakers to scramble to develop a viable cure or vaccine.
The treatment proposed by Takeda provides a standardised dose of antibodies. It also has a shelf-life much longer than unprocessed blood plasma and does not limit patients with matching blood types. So far, there aren’t any treatments for COVID-19 which have been approved by the U.S. Food and Drug Administration. However, some pharmaceutical manufacturers, such as Gilead Sciences Inc’sInc’s antiviral drug remdesivir have obtained emergency authorisation from the regulator.
Kim said in an interview, the number of patients who could benefit from the treatment, initially called TAK-888, partly depends on blood donation availability.
“This is a scarce resource,” Kim said. “Antibodies don’t survive for long, and within that period, we have to capture people. This is dependent on the progression of COVID-19 across different geographies.”
Last week Takeda said it had joined nine other companies working on plasma-based therapies to create a cure for COVID-19 patients. The CoVIg-19 Plasma Alliance also includes Biotest AG, CSL Behring, and Octapharma Plasma, among others.
“We are very pleased with the progress so far, it is a promising program,” Takeda President and CEO Christophe Weber told a teleconference, adding that it is too early to determine when or if the study’s results will contribute to its earnings, Weber said.
Takeda is cooperating with the U.S. National Institutes of Health, undergoing a clinical trial that will give all the companies in its partnership the ability to manufacture the treatment, and because it uses existing technology, it will not have standard drug industry patent protections.
Meanwhile, on Wednesday, Takeda said it expects a 35.6 per cent increase in group net profit to ¥60 billion (USD 559 million) for the current fiscal year, helped by lower costs it will book for the buyout of Irish drug manufacturer Shire PLC.
Takeda said it does not see any significant impact on its business from the COVID-19 outbreak but added that it might slow demand, significantly delay its clinical trial efforts or affect supply chains.
The company forecasts that group revenue will fall 1.3 per cent to ¥3.25 trillion this fiscal year since becoming the first Japanese pharmaceutical company to top ¥3 trillion in sales last business year, as it will move ahead with sales of non-core businesses to raise cash to reduce debts related to the Shire deal.
In the previous fiscal year, net profit for the group fell 67.3 per cent to ¥44.24 billion, squeezed by costs of the ¥6.2 trillion buyout of Shire last year in the largest-ever Japanese acquisition of a foreign company.
Takeda expects the expenditure to drop by ¥45.4 billion to ¥900 billion in the current business year.
It recorded group sales of ¥3.29 trillion last fiscal year, up 56.9 per cent from a year earlier after the Shire purchase.