Early safety and effectiveness data indicates a pathway to a cure for HIV
Code Pharma today announced positive eight-week results for human immunodeficiency virus (HIV)-drug Gammora®, showing potential to cure HIV at the cellular level. Preliminary findings were presented at the HIV Drug Therapy 2024 Conference in Glasgow, Scotland.
Gammora is a HIV-1 integrase-derived peptide that works to target the disease by stimulating the insertion of the virus's genetic material into the DNA of infected HIV cells. The pilot open-label randomized clinical trial demonstrated that the use of the drug in addition to protease inhibitor (PI)-based antiretroviral therapy (ART), a common HIV medication, can safely reduce the HIV reservoir, otherwise known as the body of cells that are infected with HIV. Gammora was shown to be safe and effective in eliminating HIV-infected cells without harming surrounding uninfected cells, which can be a result of current ART drugs.
"These incredibly positive outcomes offer new hope at a time when 40 million individuals worldwide are impacted by HIV and the current standard of care with ART drugs does not offer a cure at the cellular level," said Eynat Finkelshtein, PhD., Chief Scientific Officer of Code Pharma.
A total of 13 ART naïve individuals were enrolled and were randomized to receive 20 mg of Gammora® SC plus Darunavir-based ART (n=7) or ART only (n=6). At eight weeks, the viral load of HIV declined in all participants and death of the infected cells was observed. Due to positive results, the trial will conclude earlier than expected, reducing the number of recruitments.
"These findings demonstrate Gammora's safety and effectiveness as a new way forward in the evolving HIV functional cure landscape," said Ricardo Sobhie Diaz, Federal University of Sao Paulo UNIFESP, Brazil and principal investigator of the study. "We are encouraged by these initial results as we are witnessing for the first time a drug that leads to HIV infected cell death, in contrast to the current treatment options that suppress the virus, leading to a chronic disease. We recognize that additional trials are the right next step needed to determine how this drug could play a pivotal role in curing HIV."
As part of their ongoing research for Gammora clinical program, Code Pharma will share updated results and also preview a new clinical trial protocol at the HIV Persistence During Therapy Workshop inMiami, Florida.
About Gammora
Developed by Code Pharma, Gammora is designed to eliminate HIV by destroying infected cells and replacing them with healthy CD4 cells, as demonstrated in clinical trials. The treatment uses a synthetic peptide that forces infected cells to self-destruct without harming healthy ones. Gammora is a synthetic 16-amino-acid peptide, derived from HIV-1 integrase and initially discovered at the Hebrew University in Israel. The company is conducting in-vitro, animal, and clinical studies to confirm its safety and efficacy, while also exploring methods to ensure patient-friendly drug delivery.
About Code Pharma
Established in 2014 by entrepreneur Zyon Ayni, Code Pharma is a global pharmaceutical company committed to the field of viral infections such as HIV-AIDS and cancer research. The company aims to develop cost-effective treatments for infectious and oncological diseases. Code Pharma is headquartered in the Netherlands, with R&D activities centered in Israel.
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