Thirty clinical trials are currently underway at AKU – 23 in Karachi and seven in Nairobi. These trials are testing therapeutics and vaccines developed by American, French, Swiss, Swedish and Chinese pharmaceutical companies for use against a range of diseases, including hepatitis D, fungal infections, breast cancer, oesophageal cancer, multiple sclerosis and COVID-19. Among them are the following.
D-LIVR: Hepatitis D, or delta hepatitis, is a liver infection that can lead tocirrhosis, cancer and early mortality. The D-LIVR trial is a phase III study examining the use of lonafarnib to treat hepatitis D, either in combination with ritonavir, which is used to treat HIV, or in combination with ritonavir and peginterferon alfa, which is used to treat hepatitis B and C. Of the 400 patients enrolled in the study by more than 100 sites in 22 countries, 53 come from AKU, more than from any other site. The trial’s sponsor is U.S.- based Eiger BioPharmaceuticals.
CARES/FURI: The CARES trial is a phase III, four- country trial evaluating the use of ibrexafungerp to treat patients with candidiasis caused by Candida auris, a yeast. Candida auris is often drug- resistant and more than one-third of patients with an invasive Candida auris infection die. The trial’s sponsor is U.S.-based Scynexis Inc. Scynexis is also sponsoring the FURI trial, a phase III trial that is evaluating the use of ibrexafungerp in patients with a fungal disease that has been intolerant or refractory to standard antifungal treatment. An estimated 30 patients in four countries will be enrolled in the CARES trial and an estimated 200 patients in eight countries will be enrolled in the FURI trial.
LIDERA: The LIDERA trial is a phase III study of Giredestrant to treat estrogen-receptor positive, HER2-negative early breast cancer. Tamoxifen and aromatase inhibitors are the main therapies currently used to treat such cancer, but many patients relapse and the side effects of the drugs can lead patients to discontinue treatment. Giredestrant is a novel endocrine therapy that could decrease relapse and recurrence while causing fewer side effects. An estimated 4,100 patients from more than 50countries will be enrolled in the trial. Thesponsor is Switzerland-based Roche.
ASTEFANIA: The ASTEFANIA trial is a phase III double-blind, placebo-controlled study assessing the use of atezolizumab and trastuzumab emtansine to treat patients with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2- directed therapy and have residual invasive disease. An estimated 1,700 patients in more than 30 countries will be enrolled in the study. The sponsor is Switzerland-based Roche.
TALIOS: The TALIOS trial is a phase II study of two drugs, both bispecific antibodies, to treat advanced or metastatic squamous cell carcinoma of the oesophagus, compared with nivolumab. An estimated 210 participants from more than 20 countries will be enrolled in the trial. The sponsor is Switzerland-based Roche.
CHIMES: The CHIMES trial is a three-country, phase IV trial of ocrelizumab to treat relapsing multiple sclerosis in black and Hispanic patients. Black and Hispanic patients are underrepresented in clinical trials of multiple sclerosis treatments, yet they may suffer worse outcomes from the disease. A total of 179 patients are enrolled in the study, which is sponsored by U.S.-based Genentech.
COVID-19 TRIALS: A number of trials of COVID-19 vaccines and therapeutics to which AKU contributed have been completed and several are underway or about to begin. The COPCOV trial sponsored by Oxford University evaluating the use of chloroquine or hydroxychloroquine to prevent COVID-19 is complete, with results yet to be published. The World Health Organization’s Solidarity trial of repurposed antiviral drugs to treat COVID-19 is complete. It discontinued evaluation of lopinavir, hydroxychloroquine and interferon (IFN)-β1a for futility and found that remdesivir had no significant effect on ventilated COVID-19 patients and a small effect against death or progression to ventilation among other hospitalized patients. The ACT trial, sponsored by Canada’s Population Health Research Institute, is complete and found no support for the use of colchicine or aspirin to prevent disease progression or death in outpatients with COVID-19. Sponsored by China’s Pacific Meinuoke, the DEFLECT study of meplazumab to treat patients with severe COVID-19 reported that the drug “promoted COVID-19 convalescence and reduced mortality, viral load and cytokine levels.” A trial of two Sanofi vaccines is ongoing. A vaccine produced by China-based Livzon Pharmaceutical has reportedly been approved for use as a booster.