Gammora shows 99.9% elimination of HIV virus in first clinical trial
Unlike current antiretroviral drugs which suppress the spread of the virus, Gammora is designed to kill HIV-infected cells
Zion Medical, an Israeli based biotech company, has announced the result of their first clinical trial of HIV drug Gammora which was able to eliminate 99% of the HIV virus within four weeks of treatment.
A cure instead of a cocktail
Investigational Medicinal Product (IMP) Gammora is a synthetic peptide compound derived from the HIV enzyme integrase. This enzyme is responsible for inserting the virus’ generic material into the DNA of the infected cell. Gammora works by stimulating the integration of multiple HIV DNA fragments into the host cell’s genomic DNA, triggering the self-destruction of the infected cell (apoptosis).
Gammora stimulates the integration of multiple HIV DNA fragments into the host cell's genomic DNA, triggering the self-destruction of the infected cell
The peptide, produced by California-based PolyPeptide Labs, has the potential to cure HIV infected patients by destroying all cells carrying the HIV virus-genome. Unlike the commercially available retroviral treatments, the “cocktail”, which aims to suppress the spread of the virus, Gammora is designed to kill HIV-infected cells, without harming uninfected cells.
Abraham Loyter, professor at the Hebrew University of Jerusalem, first started research on this novelty drug a decade ago, having been granted patents for the peptide in 2015 and 2017. Zion Medical in-licensed the compound and has continued research and development through pre-clinical and clinical stages. On August 31, 2018, Zion Medical filed another patent application with the U.S. Patent and Trademark Office for an updated version of the peptide and final drug composition.
RELATED: Read about the impact digital disruption is having on clinical trials
Successful Phase 1/2a human clinical trial results
Between July and August 2018, Zion Medical conducted a Phase 1/2a human clinical trial of Gammora, reaffirming prior preclinical test results which 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.
Most patients showed a significant reduction of the viral load of up to 90% from the baseline in the first four weeks
In Part II of the study, 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 withinn four weeks.
Speaking about the trial results, Dr Esmira Naftali, Head of Development at Zion Medical, said “these first clinical results were beyond our expectations and promise hope in finding a cure for a disease that has been discovered for over 35 years”.
Next steps for Gammora
Given the limited nature of their Phase 1/2a trial, the Phase 2b trial will focus on a greater number of participants over a longer period of time, with changes in the frequency of treatment tested out. There is hope that patients using the treatment could experience a full reduction in around 6 months.
If the Phase 2b trial is successful, Zion Medical is looking for the drug to be commercially available in the next one to two years. They will be targeting countries where approvals can be made on a quicker time frame (Africa, India, China).
Zion Medical is aiming for commercial availability in the next one to two years if further trials are successful
Speaking to Pharma IQ, Zion also noted that Gammora showed effectiveness with patients who were currently resistant to the traditional “cocktail” treatment. One of the patients in the Phase 1/2a trial was resistant to the standard antiretroviral drugs. After 2 weeks with Gammora, she was able to remove 65% of her viral load.
Interestingly, throughout the 10 weeks, Gammora was shown to be highly tolerable with patients exhibiting no side effects. With chronic HIV sufferers currently taking a number of tablets daily with varying side effects, a single injection treatment with no side effects could have a drastic impact on a patient’s quality of life.
Gammora has shown effectiveness with patients who were resistant to the tranditional cocktail treatment
Over the course of the trial, patients also showed a significant increase of the CD4 cell count – up to 97% from the baseline. CD4 cells, referred to as 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 results indicate the positive impact of Gammora on the wider system of HIV-infected participants.