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. 

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.