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Author Topic: MSD/Merck’s once-weekly phase 2 study stopped - NNRTI MK-8507  (Read 1008 times)

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Offline Jim Allen

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

Full article on i-base can be found here:
https://i-base.info/htb/41647

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.
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Offline Mightysure

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Re: MSD/Merck’s once-weekly phase 2 study stopped - NNRTI MK-8507
« Reply #1 on: December 09, 2021, 03:15:29 pm »
Well that's not good news.  Hopefully they can figure out why that is happening and fix the issue if it is fixable.


Offline Jim Allen

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Islatravir HIV treatment on hold over concerns.
« Reply #2 on: February 15, 2022, 12:27:35 pm »
Islatravir on Hold

14th Feb 2022: https://www.poz.com/article/treatment-islatravir-hold

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.
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Offline Loa111

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Re: MSD/Merck’s once-weekly phase 2 study stopped - NNRTI MK-8507
« Reply #3 on: February 16, 2022, 05:33:46 am »
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?

Offline Jim Allen

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Re: MSD/Merck’s once-weekly phase 2 study stopped - NNRTI MK-8507
« Reply #4 on: February 16, 2022, 06:09:58 am »
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.

« Last Edit: February 16, 2022, 06:13:02 am by Jim Allen »
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