Andrew Cheng, Akero CEO

NASH-fo­cused Akero Ther­a­peu­tics ex­tends its run­way by an­oth­er year with Pfiz­er's help

Two years ago, Akero Ther­a­peu­tics laid out what one an­a­lyst called the “best-in-class NASH da­ta so far” in a field lit­tered with tri­al fail­ures and am­bigu­ous read­outs. Fol­low­ing those in­ter­im Phase II re­sults, Akero em­barked on a larg­er Phase II tri­al that is sup­posed to re­port out lat­er this year.

But things weren’t look­ing up for the San Fran­cis­co-based biotech when it re­vealed in its Q1 earn­ings re­port that it had just a year and a half of cash left — not enough to push its drug in­to piv­otal Phase III clin­i­cal tri­als that would sup­port an FDA ap­proval.

En­ter Pfiz­er and Her­cules Cap­i­tal.

Pfiz­er will in­vest $25 mil­lion via its Break­through Growth Ini­tia­tive to buy ap­prox­i­mate­ly 6.7% of Akero, and Pfiz­er’s VP of dis­cov­ery & de­vel­op­ment Jeff Pf­ef­fer­ko­rn will get a seat on Akero’s new­ly formed sci­en­tif­ic ad­vi­so­ry board. Along­side Pfiz­er, ven­ture lend­ing com­pa­ny Her­cules will loan up to $100 mil­lion to Akero, with $10 mil­lion avail­able im­me­di­ate­ly.

Jef­feries an­a­lyst Michael Yee (who was al­so the one who deemed Akero best-in-class in 2020) called Pfiz­er’s in­vest­ment “an in­cre­men­tal pos­i­tive.” Yee not­ed that Pfiz­er’s pre­vi­ous Break­through Growth Ini­tia­tive in­vest­ments were in ear­ly-stage com­pa­nies pri­or to key read­outs:

But the fo­cus, in our view, is PFE sees [po­ten­tial] in AKRO and an op­por­tu­ni­ty to in­vest in a promis­ing as­set, help sup­port and dri­ve for­ward a po­ten­tial im­por­tant drug, and can watch and fol­low the da­ta care­ful­ly as a pas­sive in­vestor with 7% stake.

That ex­tra cash should be enough to keep Akero afloat un­til the third quar­ter of 2024, which is two years be­yond its up­com­ing read­out of its Phase II study, it said in a press re­lease. In ad­di­tion to fin­ish­ing out its two Phase II tri­als, Akero will use the mon­ey to man­u­fac­ture a drug-de­vice com­bo and ini­ti­ate a Phase III tri­al to test that com­bo.

The fi­nanc­ing news caused Akero’s stock $AKRO to jump some 14% this morn­ing to over $9, though it is still a far cry from its peak days at $37 fol­low­ing that first Phase II an­nounce­ment.

Akero’s drug can­di­date for NASH — a dis­ease in which fat builds up in the liv­er and caus­es in­flam­ma­tion and scar­ring — is an old Am­gen drug known as efrux­ifer­min. It mim­ics FGF21, a liv­er hor­mone that reg­u­lates sug­ar up­take. In the 2020 Phase II study, near­ly half of pa­tients who re­spond­ed to the treat­ment and were biop­sied saw their NASH re­solve with­out their liv­er scar­ring wors­en­ing.

Pfiz­er it­self has al­so been work­ing to­ward a treat­ment for NASH, but with mixed re­sults. In 2018, the phar­ma dropped a Phase I can­di­date that in­hibits the fat­ty acid en­zyme DGAT2. How­ev­er, Pfiz­er is now test­ing a dif­fer­ent DGAT2 in­hibitor, er­vo­ga­s­tat, in con­junc­tion with cle­saco­stat, an in­hibitor of an­oth­er key fat­ty acid en­zyme, with re­sults ex­pect­ed in 2024.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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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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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

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.

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.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

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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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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