Filipino researchers now gear for the Phase 2 clinical trials of an anti-dengue drug, which could possibly be the first locally developed treatment for the disease.
Philippine Council for Health Research and Development (PCHRD) executive director Jaime Montoya said “there is no accepted medicine for dengue yet and what they are working on could be the first anti-dengue medicine, if ever.” The project is led by researchers from Pharmalytics Corporation, in partnership with De La Salle Medical and Health Sciences Institute, and funded by PCHRD.
Department of Science and Technology (DOST) Secretary Fortunato de la Peña said PCHRD has so far allocated P4.69 million for the Phase 1 clinical trial conducted at the Gentri Medical Center and Hospital in General Trias, Cavite. It ended in 2020. The Phase 2 clinical trial, which will last for 0 months, will be held at the same hospital and will involve about 600 participants. he added.
Montoya said the Phase 1 clinical trial determined the maximum dose of the drug that could be administered to healthy volunteers without manifesting any serious adverse effects or dose-limiting toxicities.
“Compared to the Phase 1 clinical trial where safety among healthy subjects was evaluated, Phase 2 will focus on testing the drug on a much greater number of volunteers (approximately 600) to test both its safety and efficacy. The volunteers will be dengue patients,” Montoya explained.
While Phase 1 evaluated signs of adverse events related to dosing, Phase 2 will assess parameters relating to the drug’s effectiveness to mitigate dengue disease severity by lowering the viral load, reducing vascular leakage and stimulating platelet formation, he added.
Montoya said 18 participants were included in the Phase 1 clinical trial. “Initially, 78 were enrolled. Twenty-four were randomized, then 18 were included in the analysis,” he shared, adding that Phase 2 will require at least P18 million its 600 participants. For the Phase 3 clinical trial, the anti-dengue capsule will be registered with the Food and Drug Administration (FDA) before it is distributed in the market.
De la Peña said DOST is currently preparing the budget for Phase 2 clinical trial, and once the Phase 3 clinical trial is finished and the drug has the FDA approval, the Department of Health (DOH) has to decide if technology is acceptable. Only then will the government decide if the drug would be given for free.
“There is a need to evaluate the results of the upcoming Phase 2 clinical trial to ensure that the investment for Phase 3 is correct. The adoption of the technology would be dependent on the DOH or the private sector,” he said.
The DOST’s role, De la Pena explained, is to fund or support researches that aim to develop technologies, using science, that may address problems in the country. The agency earlier supported a herbal supplement against dengue, which was made available to the market in 2019. The herbal supplement was developed through a loan by Herbanext.