Gilead and Merck Announce Temporary Pause in Enrollment for Phase 2 Study of Weekly Oral HIV Regimen Combining Islatravir and Lenacapavir
Nov 25, 2021 02:33
CST Updated
02:33
Gilead Sciences
Antiviral Drug Developer
MSD
Pharmaceutical R&D and Manufacturer
November 24, 2021 /BioValleyBIOON/ -- Gilead Sciences and Merck & Co. recently announced the suspension of patient enrollment in a Phase 2 clinical study (NCT05052996). The study is evaluating in HIV-1 infected adults who have achieved virologic suppression with antiretroviral therapy.Once-weekly oral regimen consisting of islatravir (ISL) and lenacapavirThe safety and antiviral effects, with the primary endpoint being the proportion of patients with HIV-1 RNA viral load ≥50c/ml (copies/ml) at week 24 of treatment.
This clinical study is the first research effort in the collaboration between MSD and Gilead Sciences to develop a potential long-acting HIV treatment regimen. Through the partnership announced in March 2021, the two companies aim to build on their legacy of transforming HIV care by focusing on long-acting therapies. Both parties believe that long-acting treatments could represent a meaningful innovation in the development of HIV medications.
The suspension of the study was due to a decision announced by MSD on November 18 regarding the Phase 2 IMAGINE-DR clinical trial (MK-8507-13). This study evaluates a once-weekly oral regimen consisting of MK-8507 and islatravir (ISL) for the treatment of HIV-1 infection. According to the announcement released by MSD at that time, in the IMAGINE-DR study,A decrease in total lymphocyte count and CD4+ T-cell count was observed in patients randomly assigned to receive ISL+MK-8507.
The External Data Monitoring Committee (eDMC) review determined,This effect is associated with the combination therapy of ISL and MK-8507. The greatest decrease was observed in the study groups receiving the highest doses of MK-8507 (200mg and 400mg).Based on the recommendation of the eDMC, MSD is discontinuing dosing in patients participating in the trial and will continue to monitor the patients. MSD has informed the researchers and suspended the development of MK-8507.
Chemical Structure of Islatravir (MK-8591) (Image Source: medchemexpress.cn)
Out of caution, Gilead and MSD have paused patient enrollment in the Phase 2 study of the islatravir and lenacapavir combination therapy to consider adjustments to the clinical protocol of the trial. Both parties remain optimistic about the future potential of this combination regimen, which has the potential to offer HIV patients an oral treatment option that only needs to be taken once a week.
Patients currently enrolled in the study will continue to receive the investigational drug and be monitored according to the current protocol. Clinical researchers have been informed of this action and will be notified as soon as any potential protocol adjustments are made.
Chemical Structure of Lenacapavir (GS-6207)
Islatravir is a novel oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development by MSD., used in combination with other antiretroviral drugs for the treatment of HIV-1 infection.Lenacapavir is a long-acting HIV-1 capsid inhibitor developed by Gilead Sciences., which has currently entered the review process in the United States and the European Union: in combination with other antiretroviral drugs for the treatment of multi-drug resistant HIV-1 infected individuals who have previously received multiple regimens.
Islatravir and lenacapavir both have long half-lives., and has demonstrated the activity of low doses in independent clinical studies, which supports its development into a combination regimen as a long-acting formulation, including both oral and injectable forms. While people living with HIV can take a single-pill oral regimen daily, allowing for lower-dose oral or injectable regimens has the potential to address preference considerations, as well as issues related to stigma, adherence, and privacy. (Bioon.com)
