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SINGAPORE: A potential COVID-19 antibody drug developed by a Singapore-based company will be tested in 1,305 infected patients locally and abroad, in what would be its final test before it can be approved for treatment in Singapore .
Biotechnology firm Tychan said on Friday (December 11) that it had received approval from the Health Sciences Authority (HSA) in October to begin Phase 3 of the clinical trial for its monoclonal antibody called TY027.
The antibody could slow the progression of COVID-19 in patients, help them recover faster, and provide temporary protection against the coronavirus.
During the phase 3 trial, researchers will deliver the drug directly into the blood of volunteer patients in the early stages of the disease and assess whether it can prevent further deterioration.
For example, the drug will be considered effective if a patient has a fever at the beginning of the trial and no more severe symptoms at the end.
“If the antibody is shown to be effective in this trial, it will be submitted for review by HSA and other regulatory agencies as a new drug,” Tychan said, adding that the company is trying to ensure Singapore gets the drug as soon as possible.
IT IS SAFE?
The announcement comes after Tychan announced in June that it would begin Phase 1 of the trial in healthy volunteers. The firm said on Friday that these first trials did not show “serious adverse events” as it evaluated doses up to 30 mg / kg.
READ: Singapore company to begin human clinical safety trials for potential COVID-19 treatment
“The studies supporting the application of new drugs, including chemistry, manufacturing and control, and the Phase 1 trials were completely and safely completed,” he said.
The drug was “so safe” that the researchers increased the dose from 20 mg / kg to 30 mg / kg to account for heavier patients and give the best chance of eliciting a rapid antiviral effect, said the Tychan co-founder. , Professor Ooi Eng Eong.
“So far we have not seen any side effects that could be cause for concern. In fact, most of them don’t even show any side effects. So it seems very safe. “
The length of the trial will depend on how quickly the researchers can recruit the more than 1,300 patients, who must be in the first six days of their illness.
“That’s the point where the virus is in the airways and this antibody is attacking the virus,” said Professor Ooi, who also works at Duke’s National University of Singapore School of Medicine.
“So if the virus is gone, there really is no point in treating it.”
PARTICIPANTS IN THE SINGAPORE TRIAL AND ABROAD
Recruitment for the trial will begin on Friday and will involve patients from partner hospitals: Singapore General Hospital and the National University Hospital. Suitable patients from Changi General Hospital and Sengkang General Hospital can also be referred to the trial.
Given the low incidence of COVID-19 in Singapore, Tychan said that the trial will also take place at partner hospitals abroad, such as the Sheba Medical Center in Israel.
Tychan is also exploring collaborations with medical facilities in other countries that handle coronavirus cases in a manner similar to Singapore, where potential COVID-19 patients are detected and tested early.
Professor Ooi declined to name the other countries Tychan is in discussion with, citing confidentiality agreements.
“There were some countries that we talked to that basically said there is no way they can recruit patients within the first six days because their system is so overwhelmed,” he said.
“Usually patients appear about 10 days or more after the onset (of the disease). We also found that the countries that had the technology to run these trials were so overwhelmed with severe case management that they couldn’t run the trial. “
ANTIBODY VERSUS VACCINE
Professor Ooi had previously said that the drug could potentially be used in many ways.
This includes preserving respiratory function for COVID-19 patients or disconnecting them from ventilators, and as temporary protection for healthcare workers or those traveling to COVID-19 hotspots.
While Professor Ooi acknowledged that the vaccines will provide longer-lasting protection than Tychan’s drug, he said the vaccines might not be suitable for everyone, including those on anti-cancer or autoimmune therapy, as well as those with a history of allergies.
READ: UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions
“The other thing we don’t know about the vaccine at this stage is whether it will stop the infection,” he added.
“What we do know is that it can stop the disease. Therefore, a person who is vaccinated could become infected and continue to transmit the virus. Therefore, to protect the population, we need both. “
In the US, the Food and Drug Administration has granted an emergency use authorization for two monoclonal antibody drugs to treat mild to moderate COVID-19 patients who are at increased risk of developing severe illness.
Unlike the two American antibodies that are derived from infected humans or animals, Professor Ooi said Tychan’s version was “completely engineered.” By design, this allows the antibody to target crucial parts of the virus.
Think of it as a house. You can renovate the house, but you can’t remove the pillars because everything will collapse. So, we look for the pillars of the virus so that the possibility of mutation is very, very small, “he added.
“We are confident that our antibody has a minimal chance of developing resistance. But obviously, like in everything we’ve learned about antimicrobial resistance, you can never, ever take just one drug. “
DELAYS AND CHALLENGES
Still, as with any clinical trial, “there is always the possibility” that Tychan’s trial may not be able to recruit enough volunteers, Professor Ooi said.
Phase 3 was supposed to start in August, but the researchers decided to hold back as there were so few COVID-19 patients in Singapore, he explained.
For safety reasons, patients who have poorly controlled diabetes or unstable heart disease will be excluded from the trial.
“We cannot force the patient to take the medicine,” said Professor Ooi. “It is through informed consent. For us, eliminating risk means that we have to keep finding new partners. “
Recruiting patients in other countries will also take some time, as Tychan will need to obtain approval from health regulators in those countries, as well as an ethics board, he said.
“Trials in various countries are much more difficult to administer because we really have to be sure that the protocol is followed, there is compliance, quality control and all the verifications are done,” he added.
“For Tychan, being such a small company, running a Phase 3 in different countries is a great challenge. That’s one of the considerations that … led us to change the timeline from August to now. “
MANUFACTURING
However, Professor Ooi said Tychan is already in the process of finalizing details on the mass manufacturing of his drug, noting that the antibody production technology is “much more mature” than that used to produce COVID-19 vaccines.
Monoclonal antibodies can be isolated and manufactured in large quantities to treat diseases.
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When asked if TY027 will be made in Singapore, Professor Ooi said the company has explored various options, including local production.
“I cannot give details now because these are commercial transactions that are in progress,” he said. “But we are definitely looking at all the possibilities that would give Singapore the best chance of having the drug as soon as possible.”
Studies for the development of TY027 were completed in less than four months due to “groundbreaking thinking and innovation,” Tychan said. These developments usually take between 12 and 18 months.
“We are hopeful that TY027 will pass the phase 3 clinical trial and be implemented as soon as possible to mitigate the adverse impact caused by COVID-19,” said Professor Ooi.
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