Over the week­end, Bay­er took an in­ter­me­di­ate step in its quest to chase down Bris­tol My­ers Squibb and J&J in the next-gen­er­a­tion blood thin­ner race.

In a Lancet pa­per pub­lished Sun­day de­tail­ing a Phase II safe­ty and dose-find­ing study, Bay­er’s ex­per­i­men­tal drug asun­dex­i­an re­duced the num­ber of bleed­ing events by 67% com­pared to Eliquis, a stan­dard of care. Bay­er’s next steps are to wrap up an­oth­er Phase II, fi­nal­ize the dose and push it in­to a Phase III study, like­ly by the end of this year, lead au­thor Manesh Pa­tel told End­points News.

“We feel good about the dos­ing, and we ac­tu­al­ly feel good about the fact that the high­er dose al­so has sim­i­lar rates of bleed­ing,” Pa­tel, a pro­fes­sor at Duke Uni­ver­si­ty, said. “It’s en­cour­ag­ing that it’s small num­bers, and you don’t want to over­in­ter­pret.”

When pa­tients use blood thin­ners, some­times the an­ti­co­ag­u­la­to­ry as­pects of the med­i­cine don’t just re­duce ex­cess clot­ting, but nor­mal clot­ting as well, Pa­tel said. This study aimed to ex­am­ine how asun­dex­i­an af­fect­ed the rates of such events.

It did not, Pa­tel and the pa­per stressed, look at the ef­fi­ca­cy of the drug in dif­fer­en­ti­at­ing be­tween rates of clot­ting events com­pared to stan­dard of care, which will like­ly be the fo­cus of the up­com­ing piv­otal study. Pa­tel al­so not­ed that the to­tal num­ber of bleed­ing events in the Phase II tri­al was low­er than ex­pect­ed.

Bay­er ran­dom­ized 755 pa­tients about even­ly in­to three sep­a­rate arms: a 20 mg asun­dex­i­an dos­ing arm, a 50 mg asun­dex­i­an dose co­hort and the Eliquis con­trol arm. Al­most all pa­tients, 753, were evalu­able at the end.

Pool­ing the two asun­dex­i­an arms to­geth­er, Bay­er ob­served four bleed­ing events across the 503 pa­tients, com­pared to six bleed­ing events in the 250 in­di­vid­u­als tak­ing Eliquis. As such, the com­pa­ny was able to de­ter­mine a 67% re­duc­tion in bleed­ing events be­tween the two drugs.

The study en­rolled pa­tients old­er than 45 with atri­al fib­ril­la­tion, though the av­er­age age of par­tic­i­pants was 73.7 years old. Near­ly 3 in 10 pa­tients al­so had chron­ic kid­ney dis­ease.

Asun­dex­i­an is a Fac­tor XIa in­hibitor, part of the same drug class as Bris­tol My­ers and J&J’s next-gen can­di­date, mil­vex­i­an. The part­ners here have a leg up on Bay­er in at least one area, hav­ing com­plet­ed a Phase II study ob­serv­ing a low­er rate of ve­nous throm­boem­bolism af­ter knee surgery with­out in­creas­ing risk of bleed­ing.

Fac­tor Xa in­hibitors, such as Eliquis and Xarel­to, can come with a fa­tal risk of bleed­ing, hence the push to­ward Fac­tor XIa. BMS and J&J are al­so aim­ing to launch their Phase III study for post-knee surgery VTE some­time this year.

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

GSK has landed a new first from UNICEF — the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”