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MSD/Merck’s once-weekly phase 2 study stopped - NNRTI MK-8507

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Jim Allen:
Not many details yet but seems the MK-8507 study has stopped due to concerns.

Full article on i-base can be found here:

In Short:

--- Quote ---MSD/Merck’s once-weekly phase 2 study stopped due to safety concerns with NNRTI MK-8507: islatravir studies continue

On 18 November 2021, a press release from MSD/Merck included top line concerns about an investigational NNRTI currently being studied with islatravir as a component of once-weekly oral ART.

The statement reports decreases in total lymphocyte and CD4 counts in participants receiving MK-8507 + islatravir that were dose-related to the NNRTI and were sufficient for dosing to be stopped.

--- End quote ---

Well that's not good news.  Hopefully they can figure out why that is happening and fix the issue if it is fixable.

Jim Allen:
Islatravir on Hold

14th Feb 2022:

In Short:

--- Quote ---Islatravir is being tested as a component of once-weekly HIV treatment and as a once-monthly pill or once-yearly implant for pre-exposure prophylaxis (PrEP).

Some HIV-positive people in treatment trials saw a drop in their CD4 T-cell counts, while HIV-negative volunteers in PrEP trials experienced a decrease in total lymphocytes. In December, the Food and Drug Administration placed a partial clinical hold on seven studies of daily oral islatravir plus doravirine and a full clinical hold on six studies of islatravir PrEP and injectable islatravir.
--- End quote ---

Do scientists then try to reengineer drugs like this if they don't work as expected or are but on hold? Or does it tend to be game over?

Jim Allen:
I suppose it will depend on the cause, and if it can be addressed.

This is what Merck said:

--- Quote ---Speaking with advocates, Michael Robertson, MD, of Merck Research Laboratories, said researchers are working to understand what’s causing the side effect and whether islatravir can move forward.
--- End quote ---


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