SINGAPORE - Trials for a potential treatment of Covid-19 are being accelerated, with the third and final phase for the drug due to start in a few weeks' time.
Developed by Singapore-based biotechnology company Tychan, the monoclonal antibody - or immune system protein known as TY027 - will be tested on 500 recently diagnosed Covid-19 patients.
The trial is expected to take a few months, but is the final step before the drug could be approved for treatment here.
Professor Ooi Eng Eong of Duke-NUS Medical School, who is one of the founders of Tychan, told The Straits Times on Thursday (Aug 6) that as a small company, Tychan does not have the resources to run trials with thousands of patients.
"We have to be tighter in how we recruit, and the kind of patients that we enrol. The key criterion is for the patients to be in the first seven days of illness," he said.
"Limiting the kind of patients we can enrol would give ourselves the best chance of showing, in as short a time as possible, and in as few patients as possible, that this drug works to prevent severe Covid-19."
Monoclonal antibodies are immune system proteins that are created in the laboratory, and can be specially designed and engineered to target Sars-CoV-2, the virus that causes Covid-19.
The advantage is that these antibodies can be developed over several months and produced in large batches. A single injection may last for a few weeks.
Half of the 500 patients will receive a placebo in the double-blind trial, so that the drug's effectiveness can be tested, said Prof Ooi, who added that Tychan is looking to work with hospitals under SingHealth to recruit the patients.
The process of recruitment has not started yet, because the final trial is pending approval from the authorities - the Health Sciences Authority and an ethics board.
Prof Ooi said that ideally, all of the patients in the trial would come from Singapore so that the medical treatment given to them is standardised, but Tychan is open to having participants from other countries as well, although they would have to be chosen carefully.
Patients will only take part in the trial if they provide informed consent. Tychan will pay for tests and clinic visits that are outside of the standard medical treatment given to them.
As for how long the trial will take, this would depend on how fast the 500 patients can be recruited.
In the best-case scenario, TY027 could be approved as a drug treatment for Covid-19 by next year, or even earlier, said Prof Ooi, who is deputy director of the emerging infectious diseases programme at Duke-NUS Medical School.
Clinical trials are commonly conducted in four phases, beginning with a small group first to test for the drug's safety and side effects, then moving on to larger groups to determine its efficacy.
Usually in phase three, what is being tested is whether the drug works as intended, such as preventing disease or accelerating recovery.
TY027 is being explored for the treatment of Covid-19 patients for its ability to slow down the progression of the disease and speed up recovery, as well as its potential to provide temporary protection against infection.
A six-week initial trial - known as a phase one trial - that started in June with 23 healthy volunteers had yielded good outcomes in terms of safety, said Prof Ooi. During this trial, the drug was administrated directly into the blood.
"The safety profile has been excellent, there are minimal side effects... And the results have been very, very encouraging.
"So encouraging that we are going to push that ceiling up a little bit more to a dosage of 30mg per kilogram (from 20mg/kg), so that in patients where the disease is more severe, we can give a higher dose," Prof Ooi said.
This trial had taken place less than four months since TY027 was developed.
Tychan was founded in 2014 by Prof Ooi and Professor Ram Sasisekharan of Massachusetts Institute of Technology (MIT)/Singapore-MIT Alliance for Research and Technology.
Commenting on the development, infectious diseases specialist Hsu Li Yang from the Saw Swee Hock School of Public Health said whether Tychan’s drug would be effective will depend on clinical trial results, particularly in phase three.
“Currently, it’s good that the drug is proven safe. An effective treatment, however, does not reduce the scale of an outbreak, although it will blunt the impact in terms of death and disability,” he said, adding that the only effective treatment now for severe Covid-19 is dexamethasone, a steroid drug.
Professor Paul Tambyah, president of the Asia Pacific Society of Clinical Microbiology and Infection, said: "This is a promising development as any therapy for a novel infectious disease is welcome if it works.
"The pace of therapeutic development in Covid-19 has been extremely rapid and in fact, the phase III trial of the monoclonal antibody developed by the United States National Institutes of Health began two days ago."