The ver­dict is in from Ver­tex’s clin­i­cal team.

The biotech was pre­sent­ed with a pleas­ant dilem­ma in March when a cock­tail for cys­tic fi­bro­sis mix­ing VX-​445, teza­caftor and iva­caftor passed Phase III with fly­ing col­ors, match­ing the re­sults they got for VX-659 with the oth­er two drugs, al­so known as Symdeko and Ka­ly­de­co. That left ob­servers hang­ing as to which com­bo will head to reg­u­la­tors.

Ver­tex ul­ti­mate­ly de­cid­ed to go with VX-445 — af­ter re­view­ing some more da­ta it’s dis­clos­ing to­day.

Resh­ma Ke­wal­ra­mani Ver­tex

At week 24 of treat­ment, pa­tients with one F508del mu­ta­tion and one min­i­mal func­tion mu­ta­tion on the drug main­tained ab­solute im­prove­ment in per­cent pre­dict­ed forced ex­pi­ra­to­ry vol­ume in one sec­ond of 14.3% (p<0.0001). For a key sec­ondary end­point, the same group of pa­tients saw a 63% re­duc­tion in the an­nu­al­ized rate of pul­monary ex­ac­er­ba­tions com­pared to place­bo, with the same stel­lar p-val­ue.

As pre­vi­ous­ly re­port­ed, pa­tients on the VX-445 triple had their ppFEV1 im­prove by an av­er­age of 13.8% at week 4. In a sep­a­rate tri­al for VX-​659, the num­ber was 14%.

“Peo­ple with CF who have one F508del mu­ta­tion and one min­i­mal func­tion mu­ta­tion are the largest re­main­ing group of CF pa­tients with­out a treat­ment op­tion for the un­der­ly­ing cause of their dis­ease,” CMO Resh­ma Ke­wal­ra­mani said in a state­ment.

The biotech fur­ther not­ed that the de­ci­sion “was based on a de­tailed as­sess­ment of mul­ti­ple fac­tors, in­clud­ing fa­vor­able pro­files for safe­ty, tol­er­a­bil­i­ty and drug-drug in­ter­ac­tions, the abil­i­ty for co-ad­min­is­tra­tion with hor­mon­al con­tra­cep­tives, and the lack of pho­to­sen­si­tiv­i­ty.”

Ver­tex will now take these da­ta, along­side an­oth­er 4-week Phase III study CF pa­tients with two F508del mu­ta­tions, to the FDA in Q3 and then the EMA in Q4.

Cred­it Su­isse an­a­lysts are ful­ly on board with the plan, say­ing it sig­nals a “clear path for­ward for the triple com­bo, with longer-term da­ta sup­port­ing con­tin­ued ef­fi­ca­cy. We ex­pect ap­proval in 1H20, al­low­ing the co. to treat 90% of CF pts WW. OUS re­im­burse­ment ques­tions re­main.”

Im­age: Ver­tex Phar­ma­ceu­ti­cals

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

After being forced to delay two Phase IIa trials and blaming CMC issues on a Phase Ib miss, Eliem Therapeutics believes it’s now in the clear.

The Seattle and UK-based biotech put out word Wednesday morning about how it conducted new early-stage studies to confirm why low exposure issues arose during the Phase Ib. After researchers compared the results of the studies, Eliem found “no meaningful difference” between them and ruled out CMC as the reason for the foiled Phase Ib study, the company said in a press release.