In March, Zeposia be­came the third oral S1P mod­u­la­tor to se­cure US ap­proval for mul­ti­ple scle­ro­sis. Now, the drug has suc­ceed­ed in a key ul­cer­a­tive col­i­tis study.

The im­munomod­u­la­tor, akin to oth­ers in its class, con­trols lym­pho­cyte traf­fick­ing by lim­it­ing the white blood cells to the lym­phat­ic sys­tem, in the lymph nodes, and thwart­ing their abil­i­ty to jam up lymph nodes — pre­clud­ing their abil­i­ty to pen­e­trate the blood­stream and the cen­tral ner­vous sys­tem.

In the over 1,000 pa­tient tri­al, chris­tened True North, Zeposia was test­ed against a place­bo as an in­duc­tion and main­te­nance ther­a­py in adults with mod­er­ate-to-se­vere ul­cer­a­tive col­i­tis who did not de­rive enough ben­e­fit from pre­vi­ous ther­a­py. The drug is the first S1P re­cep­tor mod­u­la­tor to demon­strate ben­e­fit in this cat­e­go­ry of pa­tients in a late-stage study, Bris­tol My­ers Squibb said on Tues­day.

The tri­al met both pri­ma­ry end­points: the pro­por­tion of pa­tients in clin­i­cal re­mis­sion based at week 10 in the in­duc­tion phase, and at week 52 for the main­te­nance phase. Zeposia’s ef­fect was high­ly sta­tis­ti­cal­ly sig­nif­i­cant (p-val­ue < 0.0001) the com­pa­ny said, adding that the drug al­so met key sec­ondary end­points.

De­tailed da­ta from the tri­al, as is cus­tom, were not pro­vid­ed at this stage.

Ul­cer­a­tive col­i­tis is a chron­ic in­flam­ma­to­ry bow­el dis­ease and is char­ac­ter­ized by an ab­nor­mal, pro­longed im­mune re­sponse that cre­ates long-last­ing in­flam­ma­tion and ul­cers in the lin­ing of the large in­tes­tine. Apart from steroids and im­muno­sup­pres­sants, oth­er treat­ment op­tions in­clude im­munomod­u­la­tors such as the block­buster TNF in­hibitors Rem­i­cade and Hu­mi­ra.

Zeposia, known chem­i­cal­ly as ozan­i­mod, was ap­proved in March but was on­ly launched days ago due to the Covid-19 out­break. Un­like the first crop of  S1P mod­u­la­tors that in­clud­ed re­quire­ments for dose titra­tion, first dose car­diac mon­i­tor­ing, and oth­er forms of clin­i­cal eval­u­a­tion and/or lab­o­ra­to­ry test­ing, the drug’s la­bel was rel­a­tive­ly be­nign with no black box warn­ing but with con­traindi­ca­tions for some pa­tients with pre-ex­ist­ing heart con­di­tions.

But the MS mar­ket is crowd­ed, and the pace of ap­provals in re­cent years has picked up, in­clud­ing Bio­gen’s Vumer­i­ty, No­var­tis’ Mayzent and EMD Serono’s Maven­clad. So it may be be dif­fi­cult for Zeposia to make a big splash in the mar­ket. So as is the case with many oth­er im­munomod­u­la­tors, the drug is be­ing tri­aled for a host of oth­er im­mune dis­eases, in­clud­ing ul­cer­a­tive col­i­tis and Crohn’s dis­ease.

AbbVie picked up some bonus points earlier this year as one of its pipeline adds from the $63 billion Allergan buyout hit its top-line marks. And now the researchers have produced the detailed data on the case they are making with regulators, with an eye on a major new market and a hoped-for approval before New Year’s.

AGN-190584 is aiming to be the first easy-on eyedrop for presbyopia, a common ailment for large numbers of people who find it harder and harder to read things like a watch or cell phone close up. Anyone who’s held a book out at arm’s length in order to read it will be very familiar with the condition, if not the exact diagnosis.

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.