Monday, February 27, 2017

Promising New Phase IIb/III Anti-Viral Results For Merck Candidate Letermovir

My fine erstwhile commenters are up early -- and at it, this morning. I thank them for that -- as I slept in just a tic, after a late night watching a highly entertaining, and (at least at the very end) shockingly goofed up Oscars (poor PwC -- they shouldn't be blamed, but they likely will be). [Nice karma, I guess -- now that "Moonlight" will get more attention for it, though -- and be in every book of entertainment history, henceforth.]

Overnight, Merck has announced the previously-telegraphed restatement of 2016 Q4 results, to reflect the $2.9 billion charge we mentioned last week -- but that should have little impact in NYSE trading, as it is well-factored in.

Also overnight, Kenilworth announced nice results on an anti-viral candidate -- in reducing bone-marrow transplant (cancer-related) mortality rates. So Merck will file with FDA on the agent later this year. From Phil Taylor, at FierceBiotech, then -- a bit -- but do go read it all:

. . . .The phase 3 test looked at how well letermovir was able to prevent cytomegalovirus (CMV) infections in adults undergoing a bone marrow or hematopoietic stem cell transplant (HSCT), a procedure typically used for patients with serious hematological cancers. All patients were seropositive for the virus—meaning they had been exposed to it before—but had no active infection.

CMV is a common virus and usually causes no harm, but when immunity is lowered as in HSCT can cause serious complications including organ damage and failure. Some patients carry CMV before transplant, while in others the virus hitches a ride with the transplanted cells.

The results showed that 37.5% of patients treated with letermovir developed CMV by week 24, compared to 60.6% for a matched placebo group. And Merck's drug also led to lower all-cause mortality at 24 weeks, at 9.8% compared to 15.9% for placebo, which was according to lead investigator Francisco Marty, M.D., of the Dana-Farber Cancer Institute told OncLive was "very compelling and interesting. . . ."

Now you know. Onward, with a flummoxed Oscars-infused smile, on a sunny but crisp morning here -- be excellent to one another. . . .


No comments: