Zion Medical, an Israel-based biotech company, announced the results of the initial human clinical trial conducted for their new HIV drug. According to a statement released by the company, the drug called Gammora was able to eliminate up to 90 percent of the virus during the first four weeks of the trial.
Zion Medical developed the drug Gammora in collaboration with the Hebrew University in Jerusalem and the Sirion Biotech in Germany. The drug is designed to attack and kill the HIV-infected cells in the human body without causing damage to the healthy cells.
In the study, researchers randomly assigned nine participating patients from the Ronald Bata Memorial Hospital in Uganda to receive different doses of Gammora between four to five weeks in July and August of this year.
While the new HIV drug is still in its first stage of exploration, the results have already offered hope that a cure for the dreaded virus is possible.
“Most patients showed a significant reduction of the viral load of up to 90% from the baseline during the first four weeks,” Dr. Esmira Naftalim, Zion Medical’s head of development, said.
How the HIV Drug Gammora Works
Investigational Medicinal Product (IMP) Gammora is a synthetic peptide compound derived from the HIV enzyme integrase, which is responsible for inserting the virus’s genetic material into the DNA of the infected cell.
Gammora stimulates the integration of multiple HIV DNA fragments into the host cell’s genomic DNA, to an extent that triggers the self-destruction of the infected cell, called apoptosis.
California-based PolyPeptide Labs produced the peptide used in the development of Gammora. This peptide reportedly has a higher potential of curing HIV-infected patients than the commercially available HIV treatments available today which merely suppress the spreading of the virus, but do not cure the infection.
Between July and August 2018, Zion Medical conducted a Phase 1/2a human clinical trial of Gammora, reaffirming results of prior preclinical tests that had showed the safety and effectiveness of the drug in killing HIV-infected cells.
In Part I of this trial, nine HIV-infected patients at the Dr. Ronald Bata Memorial Hospital in Entebbe, Uganda, were randomly assigned to receive either 0.05-0.2 mg/kg, or 0.1- 0.3 mg/kg, or 0.2-0.4 mg/kg of Gammora for up to 4-5 weeks.
Most patients showed a significant reduction of the viral load of up to 90% from the baseline during the first four weeks.
In Part II, conducted two weeks after the first, patients were given Gammora with additional retroviral treatment combined for another 4-5 weeks.
Patients received either commercially available lopinavir 800 mg and ritonavir 200 mg (LPV+r) daily in combination with Gammora 0.2-0.4 mg/kg given twice a week, or LPV+r only.
The results found that combined-treated patients demonstrated sustained viral suppression and achieved HIV-1 RNA <300 copies/mL, and showed up to 99% reduction in viral load from baseline within four weeks.
Through the 10 weeks, patients in both studies demonstrated that Gammora is a safe and well-tolerable drug, exhibiting no side effects. Patients showed a significant increase of the CD4 cell count – up to 97 % from the baseline.
CD4 cells, also referred to a T cells or T helper cells, play an important role in the body’s immune system and are an indicator of its overall health.
“These first clinical results were beyond our expectations and promise hope in finding a cure for a disease that’s been discovered over 35 years,” says Dr. Esmira Naftali, head of development at Zion Medical.
“Given the limited nature of this study, we are excited to prove the efficiency of our drug in Phase 2b with a greater number of participants over a longer period of time.”
Abraham Loyter, professor at the Hebrew University of Jerusalem, first started research on this novelty drug about 10 years ago, having been granted patents for the peptide in 2015 and 2017.