Zheng Wei, Connect Biopharma CEO

Con­nect Bio­phar­ma cel­e­brates a mid-stage win for its Dupix­ent ri­val, but shares tank af­ter in­vestors clam­or for da­ta

A suite of drug­mak­ers is look­ing to top­ple Dupix­ent in the eczema mar­ket — and on Thurs­day, Chi­na-based Con­nect Bio­phar­ma un­corked some mid-stage re­sults it says will pave the way to a piv­otal tri­al. But in­vestors want hard num­bers, and with­out any to share, the com­pa­ny’s stock $CNTB plunged more than 50% on Fri­day.

Con­nect’s mon­o­clon­al an­ti­body CBP-201 met the pri­ma­ry end­point in a Phase II tri­al, show­ing sig­nif­i­cant im­prove­ments in Eczema Area and Sever­i­ty In­dex (EASI) scores in all three dose groups, ac­cord­ing to the biotech. The treat­ment arms — 300 mg every two weeks, 150 mg every two weeks, or 300 mg every four weeks — were all sta­tis­ti­cal­ly su­pe­ri­or to place­bo at Week 16, and all showed sig­nif­i­cant im­prove­ments in the pro­por­tion of pa­tients achiev­ing at least a 50% or 75% re­duc­tion in EASI score (EASI-50 or EASI-75, re­spec­tive­ly).

The com­pa­ny al­so said, again with­out show­ing hard da­ta, the 300 mg dose giv­en every two weeks met key sec­ondary end­points, in­clud­ing the pro­por­tion of pa­tients achiev­ing an In­ves­ti­ga­tor Glob­al As­sess­ment (IGA) score of 0 or 1 (clear or al­most clear) and a re­duc­tion of ≥2 points from base­line at Week 16. Pa­tients who took CBP-201 al­so saw a sig­nif­i­cant change from base­line in week­ly av­er­age Peak Pru­ri­tus Nu­mer­i­cal Rat­ing Scale (PP-NRS), Con­nect re­port­ed.

The biotech promised to spell out the da­ta in a con­fer­ence call be­fore the end of Jan­u­ary — but for some in­vestors, that’s not soon enough. Con­nect shares were down more than 53% by mid-morn­ing, pric­ing in at $5.64.

CEO and co-founder Zheng Wei re­mained pos­i­tive, an­nounc­ing plans to launch a Phase III tri­al in mid-2022.

“This glob­al Phase 2 tri­al is al­so an im­por­tant mile­stone in in­form­ing us of the po­ten­tial of CBP-201 in oth­er in­di­ca­tions cur­rent­ly be­ing stud­ied, in­clud­ing mod­er­ate-to-se­vere per­sis­tent asth­ma and chron­ic rhi­nos­i­nusi­tis with nasal polyps,” he said in a state­ment.

The in­ci­dence of se­ri­ous and treat­ment-re­lat­ed side ef­fects was sim­i­lar in both the treat­ment and place­bo arms, Con­nect said. About 1.8% of pa­tients who took the drug ex­pe­ri­enced in­jec­tion site re­ac­tions, and 3.5% came down with con­junc­tivi­tis.

Wei met Con­nect’s oth­er co-founder, William Pan, in a mol­e­c­u­lar bi­ol­o­gy study group in col­lege in Guangzhou, Chi­na. They’ve come a long way since found­ing Con­nect in 2012, com­plet­ing a $115 mil­lion Se­ries C round last Au­gust to pro­pel their pipeline in­to Phase III. The com­pa­ny’s oth­er lead can­di­date, CBP-307, is in Phase II for ul­cer­a­tive col­i­tis and Crohn’s dis­ease.

CBP-201 works by in­hibit­ing IL-4Rα sig­nal­ing, thus con­trol­ling the sig­nal­ing of IL-4 and IL-13, two cy­tokines in­volved in the gen­er­a­tion of al­ler­gic dis­eases, the biotech says.

Dupix­ent, first ap­proved to treat eczema in adults back in 2017, al­so tar­gets IL-4Rα, pulling in more than $3.9 bil­lion in 2020. De­pend­ing on which dose Con­nect choos­es to move for­ward with, it could have the up­per hand in con­ve­nience — Dupix­ent is typ­i­cal­ly ad­min­is­tered in 300 mg dos­es every oth­er week.

Oth­er ri­vals, like Eli Lil­ly, Pfiz­er and Am­gen, are a bit fur­ther along than Con­nect. Lil­ly said in Au­gust that its mon­o­clon­al an­ti­body le­brik­izum­ab met the pri­ma­ry end­point in two Phase III tri­als, with more than half of pa­tients on the drug achiev­ing EASI-75. That same month, Pfiz­er re­port­ed re­sults from a head-to-head study that sug­gest­ed its JAK in­hibitor Cib­in­qo was “sta­tis­ti­cal­ly su­pe­ri­or” to Dupix­ent. A month lat­er, it was ap­proved in the UK to treat mod­er­ate to se­vere atopic der­mati­tis.

Am­gen bet $400 mil­lion up­front on Ky­owa Kirin’s an­ti­body back in June, and an­nounced in Oc­to­ber that the can­di­date met its pri­ma­ry end­point in a Phase II study.

Sens­ing that com­pe­ti­tion was afoot, Sanofi and Re­gen­eron read out piv­otal da­ta for the treat­ment of chil­dren be­tween 6 months to 5 years old back in Au­gust. When giv­en Dupix­ent on top of stan­dard of care top­i­cal cor­ti­cos­teroids, 28% of pa­tients achieved clear or al­most clear skin com­pared to 4% of those on place­bo, meet­ing the pri­ma­ry end­point.

“Even with Dupix­ent, there’s still a lot of space to be im­proved,” Wei told End­points News last sum­mer, adding that Con­nect hopes to beat the block­buster drug in ef­fi­ca­cy mea­sures.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Saurabh Saha, Centessa CEO (BIO19)

One of 2021's star biotech play­ers flags an­oth­er big set­back for the pipeline

Two months after scuttling their lead drug, Centessa’s executive team is back with the latest in a series of setbacks that have tanked its stock and blown holes in its strategic lineup of biotech subs.

The company reported in its Q2 post today that it has decided to scrap ZF874 after a patient demonstrated elevated liver enzymes — a classic red safety flag — in a Phase I study for alpha-1-antitrypsin (A1AT).

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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