Chi­nese Alzheimer's drug­mak­er says lack of fund­ing, Covid out­break forced it to shut­ter in­ter­na­tion­al PhI­II

Green Val­ley Phar­ma, the Shang­hai drug­mak­er that scored a stun­ning ap­proval to mar­ket an Alzheimer’s drug in Chi­na two years ago, has shut­tered a Phase III tri­al that would’ve paved its way to the FDA.

A lack of fund­ing had forced its hand, ac­cord­ing to the biotech, which said its com­mer­cial sales had with­ered amid a new Covid-19 out­break in Chi­na. It tried to raise ad­di­tion­al fi­nanc­ing but was un­able to due to “geopo­lit­i­cal cir­cum­stances and a chilly cap­i­tal mar­ket for bio­med­ical in­vest­ments.”

The com­pa­ny is­sued a press re­lease ex­plain­ing the ear­ly ter­mi­na­tion in Chi­nese last Fri­day, a few days af­ter End­points News first re­port­ed that the tri­al had been halt­ed, cit­ing tri­al sites.

Er­ic Reiman, a for­mer sci­en­tif­ic ad­vi­sor to Green Val­ley, told End­points he was in­formed the tri­al was dis­con­tin­ued “due to un­ex­pect­ed fi­nan­cial chal­lenges re­lat­ed to the Covid-19 pan­dem­ic in Chi­na.”

The re­lease con­firmed his com­ment and elab­o­rat­ed on the de­ci­sion.

GV-971, the drug in ques­tion, is an oral cap­sule con­sist­ing of an oligosac­cha­ride de­rived from sea­weeds. While re­searchers had ini­tial­ly thought it may work by al­ter­ing amy­loid be­ta, Green Val­ley ul­ti­mate­ly pro­posed that it works through the gut-brain ax­is, tam­ing down ner­vous sys­tem in­flam­ma­tion through mod­u­lat­ing gut mi­cro­bio­ta.

En­dorsed by some high-pro­file names in the US, its sur­prise 2019 ap­proval came at a time Bio­gen had scrapped two tri­als for ad­u­canum­ab, then the fore­most Alzheimer’s can­di­date around the world, be­fore ul­ti­mate­ly re­vers­ing course and steer­ing it to­ward a con­tro­ver­sial ap­proval. The stun­ning news out of Chi­na sparked a whole gamut of re­ac­tions among ex­perts, from cau­tious op­ti­mism to skep­ti­cism to be­wil­der­ment.

The Phase III study kicked off in Oc­to­ber 2020 and was de­signed to en­roll 2,046 pa­tients with mild to mod­er­ate Alzheimer’s.

In the end, Green Val­ley screened 1,308 par­tic­i­pants across 11 coun­tries or re­gions as of April 26, 439 of whom were ran­dom­ized in­to the study. Among them were 257 sub­jects in North Amer­i­ca, 118 in Eu­rope and 64 in Chi­na.

An in­de­pen­dent da­ta safe­ty mon­i­tor­ing board had met ear­li­er this year at the 10% en­roll­ment mile­stone to re­view the safe­ty da­ta and con­clud­ed that there were no safe­ty risks that would af­fect the con­tin­u­a­tion of the tri­al, the com­pa­ny not­ed.

How­ev­er, the do­mes­tic out­break that start­ed in ear­ly 2022 had a huge im­pact on GV-971 sales, which large­ly went through in-hos­pi­tal pre­scrip­tion, Green Val­ley said. Those al­so co­in­cid­ed with an en­roll­ment spike in oth­er coun­tries — trans­lat­ing to a short-term cash crunch. At the same time, the pan­dem­ic made off-line as­sess­ment of tri­al par­tic­i­pants dif­fi­cult, which con­tributed to a grow­ing dropout rate, all con­tribut­ing to ris­ing costs and risks.

Right now, the com­pa­ny sug­gest­ed that it will wind down the tri­al and fo­cus on the Chi­nese mar­ket. From a state­ment:

At about 10 mil­lion, our coun­try has the world’s largest Alzheimer’s pa­tient com­mu­ni­ty. As the pan­dem­ic al­le­vi­ates, Green Val­ley will ac­cel­er­ate the work of mar­ket and hos­pi­tal ac­cess af­ter GV-971 en­ters na­tion­al in­sur­ance, and fo­cus our re­sources on do­ing well on the ex­ist­ing mar­ket. With GV-971 demon­strat­ing treat­ment ben­e­fits on a grow­ing num­ber of pa­tients over the past two or so years on the mar­ket, more and more doc­tors will be­gin to rec­og­nize its unique clin­i­cal val­ue, it will be in­clud­ed in au­thor­i­ta­tive clin­i­cal guide­lines and ex­pert con­sen­sus as well as na­tion­al in­sur­ance. In the fu­ture it has the po­ten­tial to ben­e­fit even more Chi­nese pa­tients. Mean­while based on our mis­sion of “On­ly mak­ing med­i­cines that hu­mans most long for,” Green Val­ley will per­sist in our goal of bring­ing GV-971 to the in­ter­na­tion­al mar­ket, and restart in­ter­na­tion­al stud­ies of GV-971 when the sit­u­a­tion al­lows, so that this orig­i­nal AD med­i­cine can reach pa­tients around the world.

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.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

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.