SINGAPORE, Dec 11 — The Singapore-based biotechnology company Tychan has started the third and final phase of its clinical trials on an antibody drug for patients with Covid-19 after it received the nod from the Health Sciences Authority (HSA) in October.
The trials, which began today, will involve 1,305 volunteers. The company is in the process of recruiting trial candidates.
Trials for the drug, known as TY027, will be done at the Singapore General Hospital (SGH) and National University Hospital (NUH). Patients may also check if they are suitable for the trials at Changi General Hospital and Sengkang General Hospital. If so, they will be referred to SGH or NUH.
Owing to the low incidence of the coronavirus in Singapore, the trials will also involve hospitals overseas, such as Israel’s Sheba Medical Centre.
TY027 is being explored as a treatment for patients with Covid-19 to slow the progression of the disease and speed up recovery. It could also provide temporary protection against infection from SARS-CoV-2, the virus that causes Covid-19.
Infectious diseases expert Ooi Eng Eong, who co-founded Tychan, told reporters in a video conference today that the firm had chosen Israel as a partner because the country allows it to carry out studies in a similar fashion as Singapore.
Israel is also not overwhelmed by the pandemic and has the capacity to conduct the trials.
Israel has recorded more than 352,000 Covid-19 cases and 2,960 deaths.
Professor Ooi, who is also deputy director of Duke-NUS Medical School’s emerging infectious diseases programme, was unable to reveal the other countries Tychan is in talks with because of a non-disclosure agreement.
On why Tychan has to tie up with other countries to conduct the trials, Prof Ooi said that Singapore has been successful in containing Covid-19 and, thus, there are not enough suitable candidates.
Candidates for the trial must be Covid-19 patients within the first six days of illness.
The lack of suitable trial volunteers in Singapore is also why Tychan had delayed moving into the third phase of clinical trials, even though media reports previously quoted Prof Ooi saying they were slated to start in August.
TY027 has been in development since February 25. It is a partnership between Tychan and a stable of government departments, including the Ministry of Defence, Ministry of Health and Economic Development Board.
In June, it entered the first phase of human trials, which involved 23 volunteers.
Prof Ooi said the Phase One trial went very well and the antibodies were so safe, with no serious adverse effects, that researchers increased the dosage from 20mg per kg to 30mg per kg.
The decision was made to “give ourselves the best chance of eliciting a quick antiviral effect”.
He added that researchers debated among themselves on whether to move to Phase Two trials — this phase would only further test whether the drug is safe. A decision was made to skip to Phase Three.”
Phase Two is not powered to address efficacy… you cannot conclude that a drug works, only that it is safe and has a chance of working,” he said. “In this time of pandemic, and with all the uncertainty, we might as well go to the direct answer (in Phase Three).”
The results of Phase Three trials will hinge on how quickly Tychan can recruit volunteers.
Vaccines alone not enough
When asked how the antibody drug differs from a vaccine, Prof Ooi said that a vaccine alone would not get rid of Covid-19.
For example, he noted that the protection a vaccine offers against the disease is about 95 per cent. That means there is still a chance for vaccinated individuals to contract the virus.
Furthermore, vaccination may not be suitable for patients undergoing cancer treatment or those with a history of allergies.
“Moreover, we do not know how long the protection from vaccines will last. At some point, as the vaccine immunity wanes, there is a chance that Covid-19 could reappear,” he said.
It is thus important to have both forms of treatment.
An antibody drug will allow those unable to be vaccinated to be protected in some way, said Prof Ooi.
He does not foresee issues mass-producing TY027, as the technology for such production of antibody drugs is mature, compared with new vaccine production.
“To really tackle this problem of a re-emergence of a Covid-19 epidemic... having treatment (with antibody drugs) for Covid-19 that really drives the virus load down, so that we do not get severe disease, is still important to prevent our healthcare system from being choked up with severe cases.” — TODAY
