With a full slate of in­jectable CGRP mi­graine drugs po­si­tion­ing them­selves at the fin­ish line for FDA ap­provals for chron­ic cas­es, Al­ler­gan $AGN to­day took an­oth­er big step for­ward with its pill for acute cas­es. The com­pa­ny hailed a Phase III win for its first late-stage test of ubro­gepant, one of the mi­graine drugs it ac­quired from Mer­ck a lit­tle more than two years ago.

Re­searchers say the drug hit both of the co-pri­ma­ry end­points for acute mi­graine, with a sta­tis­ti­cal­ly sig­nif­i­cant beat for a place­bo arm in be­ing pain free and free of most symp­toms of mi­graine two hours af­ter ini­tial treat­ment.

David Nichol­son, Al­ler­gan

Al­ler­gan plans to pub­lish more of the da­ta lat­er in the year, with the sec­ond Phase III read­out com­ing in the first half of 2018. Al­ler­gan ex­ecs in turn ex­pect that will set up an NDA for next year.

Mean­while, Am­gen and No­var­tis are in the lead on the in­jectable side of the CGRP race, with the FDA re­view­ing their drug, Aimovig. The drug will like­ly be chal­lenged by a group of com­peti­tors rang­ing from Eli Lil­ly $LLY to Te­va $TE­VA and Alder $AL­DR that have all demon­strat­ed broad­ly sig­nif­i­cant da­ta in cut­ting the num­ber of mi­graine days ex­pe­ri­enced by a chron­ic suf­fer­er.

Com­mit­ted to in­no­va­tion in #mi­graine treat­ments. @Al­ler­gan An­nounces Pos­i­tive Top Line Phase 3 Re­sults for Ubro­gepant – an Oral CGRP Re­cep­tor An­tag­o­nist for the Acute Treat­ment of Mi­graine https://t.co/ytP2W1CpW5

— Brent Saun­ders (@brentl­saun­ders) Feb­ru­ary 6, 2018

“We are pleased with the fa­vor­able re­sults of our ACHIEVE I study, which sup­port the ef­fi­ca­cy, safe­ty, and tol­er­a­bil­i­ty pro­file of ubro­gepant. We are con­fi­dent that ubro­gepant, an oral cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) re­cep­tor an­tag­o­nist will be an op­tion for the treat­ment of mi­graines in adults,” said David Nichol­son, Al­ler­gan’s head of R&D. “Al­ler­gan re­mains com­mit­ted to iden­ti­fy­ing, de­vel­op­ing and bring­ing to mar­ket ther­a­pies that ad­dress un­met need for pa­tients suf­fer­ing from this de­bil­i­tat­ing dis­ease.”

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.