Rich Hey­man's Metacrine grabs a $22M round in search of a su­pe­ri­or NASH drug

A start­up found­ed by biotech A-lis­ters has scored $22 mil­lion in a Se­ries B round to help de­vel­op its NASH drug. The com­pa­ny, called Metacrine, is pur­su­ing a tar­get its founders think can out­per­form the field’s fierce com­pe­ti­tion.

The round was led by new in­vestor New En­ter­prise As­so­ci­ates, while old in­vestors stayed on board. The mon­ey brings the com­pa­ny’s to­tal haul to $60 mil­lion since its 2015 launch, no doubt buoyed by the rep­u­ta­tion of the peo­ple in­volved.

The com­pa­ny was co-found­ed by se­r­i­al en­tre­pre­neur Rich Hey­man — the man be­hind Aragon and Ser­agon, which both sold for over $1 bil­lion in the span of one year — and Ronald Evans, the Salk sci­en­tist be­hind a slew of biotech com­pa­nies, in­clud­ing Lig­and Phar­ma­ceu­ti­cals and the re­cent­ly ac­quired Mi­to­bridge. Both Evans and Hey­man are still in­volved with Metacrine: Hey­man is chair­man, while Evans sits on the board.

Ken Song, Metacrine

Metacrine has thus far kept its plans most­ly un­der wraps, say­ing sim­ply the com­pa­ny was work­ing on pro­grams for di­a­betes, liv­er dis­or­ders, and oth­er meta­bol­ic dis­ease. Now, they’re charg­ing for­ward on a pro­gram for fat­ty liv­er dis­ease, which it plans to take to the clin­ic ear­ly next year.

The com­pa­ny’s CEO, Ken Song, who’s led Metacrine for a lit­tle over a year now, tells me he’s acute­ly aware of the need to dif­fer­en­ti­ate from oth­er play­ers pur­su­ing NASH.

“This is prob­a­bly one of the most com­pet­i­tive ar­eas in biotech right now,” Song said. “It’s an enor­mous dis­ease in­di­ca­tion, and there’s no ap­proved ther­a­pies in the space. Those two fac­tors are dri­ving a lot of in­ter­est. Every week there’s an­oth­er new an­gle or new tar­get.”

The start­up’s shtick is not to find a brand new tar­get to take down NASH. In­stead, Song said the com­pa­ny is fo­cus­ing on the on­ly clin­i­cal­ly-val­i­dat­ed tar­get in the space: the Far­ne­soid X Re­cep­tor. FXR is a nu­clear hor­mone re­cep­tor, which is a class of pro­teins Evans hap­pens to be an ex­pert in.

“While there are many drug tar­gets com­pa­nies are go­ing af­ter, there’s on­ly one that’s been clin­i­cal­ly shown to be ef­fi­ca­cious at both re­solv­ing the dis­ease and re­vers­ing fi­bro­sis,” Song said.

The tar­get has been val­i­dat­ed by In­ter­cept, a com­pa­ny that’s in its own Phase III tri­al in­volv­ing a bile acid FXR ag­o­nist in NASH. But Song said this ap­proach ap­pears to come with some un­want­ed side ef­fects for pa­tients: itch­i­ness and a boost to their LDL cho­les­terol.

Metacrine has ideas on what’s caus­ing both side ef­fects: the bile acid. So the com­pa­ny plans to try out a non-bile acid FXR ag­o­nist in hopes to re­solve the is­sues. Oth­er com­pa­nies have tried de­vel­op­ing NASH drugs with non-bile acid FXR ag­o­nists be­fore, but these mol­e­cules tend to clear out of the body too quick­ly to be “best-in-class” when it comes to be­ing ef­fec­tive.

“Bile acids nat­u­ral­ly un­der­go re­cir­cu­la­tion in the body, so the re­cep­tor is con­tin­u­al­ly ex­posed to its lig­and,” Song said. “When com­pa­nies de­vel­op a non-bile acid mol­e­cule, the mol­e­cules tend to be tran­sient. So you take a pill, these mol­e­cules get ab­sorbed and rapid­ly cleared from the body. We are de­sign­ing a mol­e­cule that doesn’t get cleared rapid­ly, but rather ex­tends the amount of drug ex­po­sure in the blood through­out the day.”

Song said the com­pa­ny ex­pects to com­plete Phase I tri­als by the end of 2018.

While most of this new cash will go to­wards the NASH pro­gram, Metacrine al­so has plans to put some mon­ey to­wards new (undis­closed) dis­ease tar­gets. The com­pa­ny al­so has a type 2 di­a­betes pro­gram in de­vel­op­ment in col­lab­o­ra­tion with No­vo Nordisk.

As part of the Se­ries B round, Car­ol Gal­lagher, a part­ner at new in­vestor NEA, will join Metacrine’s board.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.