MANILA - A study into the investigational COVID-19 drug Molnupiravir is set to be conducted by the second week of November in Filipino households.
The drug was developed by pharmaceutical company Merck and Ridgeback Biotherapeutics in the United States and Canada.
Dr. Beaver Tamesis, president of the Pharmaceutical & Healthcare Association of the Philippines (PHAP), said COVID-19 patients' household members and other close contacts will be included in the clinical trial set next month.
The Philippines is among the countries that took part in the worldwide initial clinical trial for Molnupiravir. According to Tamesis, a total of 27 volunteers have participated in the trial.
“We don't have the specific analysis of the 27 volunteers who participated, we still have to 1,500, we only have reported on the 775, we will try to get the Philippine-specific hospitals. I’m not aware which hospitals these are,” Tamesis said during FOCAP's online forum Monday afternoon.
Four hospitals have been given a compassionate special permit (CSP) for Molnupiravir, but are not necessarily sponsoring the clinical trials in the country next month, he said.
A CSP or an emergency use authorization (EUA) is required in the Philippines to allow the use of investigational drugs like Molnupiravir.
According to Tamesis, the MK-1482 study showed at least 1,500 subjects who tested positive for COVID-19 participated in the study therapy.
Experts considered those at risk for progression, those with cardiac and pulmonary problems, diabetes, obesity, and senior citizens 60 years old and above.
Subjects under the Molnupiravir group were given the pill for 5 days and were monitored at home for a month. The interim analysis showed a 50% reduction in the death rate.
The study further showed that any adverse effects were closely comparable in the Molnupiravir and placebo groups. There were also fewer subjects in the Molnupiravir group that discontinued the study therapy due to an adverse event as compared to those under placebo.
For the Molnupiravir group, adverse events were recorded in 35% of the participants; 40% on those under the placebo; drug-related adverse event for Molnupiravir at 12%, while the placebo group had 11%; adverse effects leading to treatment discontinuation was at 1.3% for Molnupiravir and 3.4% for placebo, the adverse event summary showed.
“We have no doubt that the full paper will show the same trends, right now we are really quite happy with the result,” Tamesis said.
“Remember this is double-blind study, even the patient doesn’t know what was given to her, double-blind placebo studies. We do the visits, we do everything that's required,” Dr. Joel Santiaguel, a pulmonologist and UP professor, said.
“As of now, what I can say, there are no adverse effects, they've (subjects) responded really well,” he said.
Last week, Food and Drug Administration chief Eric Domingo said he is optimistic the COVID-19 pill may be available in the country before the year ends.
“Hindi pa kasi sila nag-aapply ng EUA sa atin eh, hindi pa siguro ngayong buwan 'yan ano, possibly towards the end of the year or baka early next year pa yung application ng EUA nila sa atin,” Domingo told ABS-CBN News.
“Nape-prevent niya 'yung progression to severe illness and death by as much as 50% so malaking bagay yun in case na maging available siya,” he said.
Tamesis, managing director of Merck Sharp & Dohme (MSD) Philippines, said MSD will not be securing Molnupiravir's emergency use authority in the Philippines.
“We will not file with the FDA. Our partners will be pursuing registration in the Philippines. (It's) subject for negotiation. There are companies, local companies that have reached out. Even local manufacturers are asking about it. We are in talks what's the best way forward,” he said.
According to Tamesis, a treatment course is estimated to last for 5 days with the patient given 800mg of Molnupiravir per day. To maximize its effect in COVID-19 patients, the drug should also be given during the early stage of infection or during the first 5 days of symptoms.
In the United States, the Molnupiravir treatment course is rumored to cost around $700 or about P35,000.
“I have great confidence there's no way it would be at 700 US dollars (here) if that's the figure going around in the US, I’m sure that's not the price, I’m not sure what the price will be, but I’m sure it won’t be at $700,” he stressed.
PHAP is optimistic that after promising findings from Molnupiravir, the pill can be among major breakthroughs in strengthening the country’s treatment capacity against COVID-19.
“So far it seems to work with the coronavirus. We’ve also been looking at it for influenza, for Ebola. Potentially we have a broad spectrum anti-viral here. If this drug merits full marketing authorization, I would suggest the Philippine government should be looking at it as part of the COVID preparedness response for the future," said Tamesis.
Tamesis also reminded the public that getting vaccinated against COVID-19 is still of utmost priority.
“This particular drug just completes the full spectrum. It does not substitute vaccination,” he stressed.