NEW YORK/TOKYO – Takeda Pharmaceutical Co. could start a clinical trial as early as July for a potential treatment for COVID-19 based on antibodies in blood from recovered coronavirus patients, company executives said.
The clinical trial would include hundreds of patients and take several months to complete. If successful, Takeda could file for approval by U.S. authorities this year, said Julie Kim, president of the plasma-derived therapies unit of Takeda.
“When the product will be available beyond the clinical study is still a bit unclear,” Kim said Wednesday on an investor call. “But we do expect that before the end of the year, we should see some information in terms of broader use.”
Fighting disease with blood from survivors is an ancient strategy that has not been well tested for the novel coronavirus, which emerged in China late last year and has spread around the world. Some hospitals are already collecting blood plasma from recovered patients and infusing it into people who are sick with the disease caused by the coronavirus, but its efficacy is still being studied.
The new coronavirus has infected 4.3 million people worldwide and nearly 300,000 have died, according to a Reuters tally. The pandemic has spurred several drugmakers to race to develop a viable treatment or vaccine.
Takeda’s proposed treatment offers a standardized dose of antibodies. It also has a much longer shelf life than unprocessed blood plasma and doesn’t need to be limited to patients with matching blood types. There are not yet any treatments for COVID-19, the disease caused by the coronavirus, which have been approved by the U.S. Food and Drug Administration. However, some such as Gilead Sciences Inc’s antiviral drug remdesivir have received emergency authorization from the regulator.
The number of patients who could be aided by Takeda’s treatment, initially called TAK-888, depends in part on the availability of blood donations, Kim said in an interview.
“It is a scarce resource,” Kim said. “Antibodies don’t last forever and we have to capture people within that time window. This is dependent on the progression of COVID-19 within different geographies.”
Takeda said last week it has joined with nine other companies that work on plasma-based therapies to develop a treatment for COVID-19 patients. The CoVIg-19 Plasma Alliance also includes Biotest AG, CSL Behring, and Octapharma Plasma, among others.
“It is a promising program, and we are really pleased with the progress so far,” Takeda President and CEO Christophe Weber told a teleconference, adding that it is too early to assess when or if the study’s results could contribute to its earnings, Weber said.
Takeda is working with the U.S. National Institutes of Health on a clinical trial that would give all the companies in its partnership the ability to produce the treatment, which will not have standard drug industry patent protections because it uses existing technology.
Meanwhile, Takeda said Wednesday it expects a 35.6 percent rise in group net profit to ¥60 billion ($559 million) for the current fiscal year, helped by lower costs it will book for the purchase of Irish drugmaker Shire PLC.
Takeda said it sees no major impact on its business from the virus outbreak but added it might slow demand, significantly delay its clinical trial programs or disrupt supply chains.
The company projects group revenue will fall 1.3 percent to ¥3.25 trillion this fiscal year after becoming the first Japanese pharmaceutical company to top ¥3 trillion in sales last business year, as it will push ahead with sales of noncore businesses to generate cash to cut debts related to the Shire buyout.
In the previous fiscal year, group net profit dropped 67.3 percent to ¥44.24 billion, squeezed by costs of the ¥6.2 trillion purchase of Shire last year in the biggest-ever Japanese acquisition of a foreign company.
Takeda expects the expense to fall by ¥45.4 billion to ¥900 billion in the current business year.
It logged ¥3.29 trillion in group sales last fiscal year, up 56.9 percent from a year earlier after the purchase of Shire.