Jean-Paul Clozel, Idorsia CEO (AP Images)

Idor­sia claims PhI­II win for hy­per­ten­sion drug at cen­ter of $230M J&J deal

Months af­ter earn­ing its first ap­proval, Idor­sia is back with a Phase III win for a dif­fer­ent, J&J-part­nered drug.

The Swiss biotech said aproci­ten­tan, its dual en­dothe­lin re­cep­tor an­tag­o­nist, has aced a late-stage tri­al in­volv­ing pa­tients with re­sis­tant hy­per­ten­sion, spurring sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in blood pres­sure on top of back­ground ther­a­py.

The topline re­sults con­firm Idor­sia’s hy­poth­e­sis that en­dothe­lin is the “miss­ing link” for pa­tients whose hy­per­ten­sion can’t be con­trolled by ex­ist­ing ther­a­pies, ac­cord­ing to CSO Mar­tine Clozel. By its es­ti­mate, by 2025 that group could to­tal 10 mil­lion in the US alone.

“I have long been con­vinced that re­sis­tant hy­per­ten­sion is on­ly re­sis­tant to treat­ment be­cause the en­dothe­lin sys­tem had not been tack­led,” she said in a state­ment. “The ob­ser­va­tion of high en­dothe­lin lev­els in pop­u­la­tions most at risk of de­vel­op­ing re­sis­tant hy­per­ten­sion, as well as the close as­so­ci­a­tion be­tween en­dothe­lin and the co­mor­bidi­ties of­ten seen in pa­tients with re­sis­tant hy­per­ten­sion, sug­gest­ed that en­dothe­lin is a key con­trib­u­tor to the prob­lem.”

J&J paid Idor­sia $230 mil­lion back in 2017 to snag com­mer­cial­iza­tion rights to the drug on the back of its $30 bil­lion buy­out of Acte­lion, which was run by the hus­band-and-wife team of CEO Jean-Paul Clozel and CSO Mar­tine Clozel. They spun out the R&D work in­to Idor­sia, and notched their first OK ear­li­er this year when the FDA ap­proved its treat­ment for in­som­nia. The EMA fol­lowed with its own en­dorse­ment days ago.

In the Phase III tri­al, which en­rolled 1,971 pa­tients, in­ves­ti­ga­tors first gave all par­tic­i­pants a fixed-dose com­bi­na­tion of a cal­ci­um chan­nel block­er (am­lodip­ine), an an­giotensin re­cep­tor block­er (val­sar­tan) and a di­uret­ic (hy­drochloroth­iazide) for at least four weeks be­fore en­ter­ing a four-week run-in pe­ri­od where place­bo was added to the back­ground ther­a­py. Pa­tients whose blood pres­sure re­mains con­sis­tent­ly high were then moved in­to the first treat­ment part of the study.

A to­tal of 730 pa­tients were ran­dom­ized to one of three groups: 12.5 mg aproci­ten­tan, 25 mg aproci­ten­tan or place­bo.

Af­ter 4 weeks of treat­ment, a sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful re­duc­tion in the pri­ma­ry end­point mea­sure of sys­tolic blood pres­sure – as­sessed by mea­sure­ment at trough of un­at­tend­ed au­to­mat­ed of­fice blood pres­sure (AOBP) – was ob­served in both the 12.5 mg (p<0.005) and 25 mg (p<0.005) aproci­ten­tan groups com­pared to place­bo.

In Part 2, all pa­tients got 25 mg aproci­ten­tan for 32 weeks, where the re­duc­tion in blood pres­sure was ob­served across groups.

Then mov­ing on­to Part 3, Idor­sia re-ran­dom­ized pa­tients so that half got place­bo again — and saw their sys­tolic blood pres­sure in­crease.

“This pro­vid­ed repli­ca­tion of the treat­ment ef­fect of aproci­ten­tan and con­firmed its durable an­ti­hy­per­ten­sive ef­fect,” the com­pa­ny wrote.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

David Hung, Nuvation Bio president and CEO (Nuvation Bio)

FDA places par­tial clin­i­cal hold on David Hung biotech af­ter cer­tain can­cer pa­tients ex­pe­ri­ence eye in­flam­ma­tion

Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung — of Medivation fame — has run into its first setback.

San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.