Akero el­bows its way in­to a crowd­ed NASH field, with $65M and a strat­e­gy for tack­ling a block­buster mar­ket

Over the last few weeks we’ve been treat­ed to a cou­ple of sto­ries about small biotechs which en­joyed a swift run-up in stock val­ues af­ter post­ing their beau­ty shots of clin­i­cal da­ta for NASH drugs. NASH re­mains the big new dis­ease tar­get that is suck­ing up a lot of R&D at­ten­tion at large and small bio­phar­mas around the world, and in­vestors are look­ing to ride one of the win­ning play­ers to the promised land.

You can now add a new com­pa­ny to watch in this sul­try re­search zone. And it’s a brand new ba­by that’s been gift­ed with $65 mil­lion in op­er­at­ing cap­i­tal and a deeply ex­pe­ri­enced Pfiz­er vet to head up the re­search work.

The com­pa­ny has been dubbed Akero, which is de­but­ing to­day with a Cam­bridge base and $65 mil­lion in Se­ries A cash, with Ap­ple Tree Part­ners lead­ing the way. 

Now, with all the clin­i­cal work that’s been go­ing on for the last few years in NASH, you might think that we’ve al­ready seen the even­tu­al win­ners jump for­ward. But then, you haven’t met the peo­ple at Akero.

The start­up has in-li­censed an FGF21 drug that’s al­ready been through ear­ly-stage work at Am­gen, which let it go be­cause of their move away from meta­bol­ics.

This isn’t the first FGF21 in the clin­i­cal. Bris­tol-My­ers has one that has been through Phase II. 

Tim Rolph

“My ex­pe­ri­ence with FGF21 goes back 8 years,” says Akero CSO Tim Rolph. It start­ed at Pfiz­er and con­tin­ued af­ter he left the phar­ma gi­ant. The sci­ence around FGF21, he adds, has grown ex­po­nen­tial­ly in the last 3 to 4 years. 

“It’s a mech­a­nism that us­es the whole body to get to a bet­ter place,” says Rolph. “It plays an es­sen­tial role restor­ing cells un­der stress — that’s what drove my in­ter­est.”

Jonathon Young, the CEO, and Rolph went to go out in search of drug, and found this pro­gram at Am­gen, which li­censed it out. And the two are pumped about the en­gi­neer­ing work that has gone in­to it to give the drug longer dura­bil­i­ty.

Ap­ple Tree Part­ners, where Young has been a part­ner, seed­ed the project. At­las Ven­ture, ven­Bio Part­ners and Ver­sant Ven­tures all joined as co-leads, mak­ing an im­pres­sive group of deep-pock­et in­vestors. They’ll be rep­re­sent­ed on the board by Aaron Kantoff, Kevin Bit­ter­man, Aaron Roys­ton and Gra­ham Walm­s­ley.

Young — like a lot of start­up biotech CEOs — gets a lit­tle skit­tish when you try to nail down the staff plans right now. There are the two founders, he says, with plans to add more em­ploy­ees. We’ll see how that goes. 

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.