Ger­many’s Boehringer In­gel­heim is ex­pand­ing its am­bi­tions in NASH, the un­treat­ed fat­ty liv­er dis­ease that has rav­aged the de­vel­oped world, cre­at­ing a lu­cra­tive tar­get that has sparked a flur­ry of drug de­vel­op­ment from bio­phar­ma firms big and small.

The com­pa­ny in 2017 joined forces with Dicer­na in a re­search and li­cens­ing deal to de­vel­op RNA in­ter­fer­ence (RNAi) ther­a­peu­tics for chron­ic liv­er dis­eases, in­clud­ing NASH. On Mon­day, Boehringer tied up with South Ko­rea’s Yuhan Corp to fight NASH in a deal worth up to $870 mil­lion — up­front and near term pay­ments of $40 mil­lion as well as po­ten­tial mile­stones pay­ments of $830 mil­lion.

The drug the two will col­lab­o­rate on is a dual ag­o­nist: the gut-de­rived hor­mone GLP-1 with a hor­mone se­cret­ed by the liv­er FGF21. NASH is char­ac­ter­ized by a buildup of ex­cess fat in the liv­er that in­duces chron­ic in­flam­ma­tion and even­tu­al­ly cul­mi­nates in scar­ring that can lead to cir­rho­sis, liv­er fail­ure, can­cer and death. The dis­ease, which is typ­i­cal­ly as­so­ci­at­ed with obe­si­ty and di­a­betes, is set to eclipse he­pati­tis C as the lead­ing rea­son for liv­er trans­plants by 2020.

Pre­clin­i­cal ev­i­dence us­ing GLP1R/FGF21R ag­o­nist sug­gests high ef­fi­ca­cy — the drug is ex­pect­ed to re­duce liv­er cell in­jury and he­pat­ic in­flam­ma­tion by re­duc­ing fat ac­cu­mu­la­tion in the liv­er as well as hav­ing di­rect an­tifi­brot­ic ef­fects, Boehringer said.

Jung Hee Lee Yuhan

“This mol­e­cule, which is a fu­sion pro­tein uti­liz­ing the long-act­ing (HyFc) tech­nol­o­gy of Genex­ine, has been de­vel­oped in-house by Yuhan Cor­po­ra­tion. Not on­ly is our col­lab­o­ra­tion with Boehringer In­gel­heim on this mol­e­cule Yuhan’s first ex­ter­nal part­ner­ship with bi­o­log­ics, it is al­so the very first out-li­cens­ing of bi­o­log­ics tar­get­ing NASH from Ko­rea,” not­ed Yuhan chief Jung Hee Lee in a state­ment.

Boehringer has an ex­ist­ing ar­se­nal of mar­ket­ed drugs for car­diometa­bol­ic dis­ease, in­clud­ing prod­ucts for throm­boem­bol­ic dis­ease, type 2 di­a­betes, and hy­per­ten­sion. Yuhan has long served as a com­mer­cial part­ner for se­lect­ed Boehringer car­dio­vas­cu­lar and meta­bol­ic prod­ucts in Ko­rea.

NASH is a crowd­ed field — that has seen a raft of tri­al fail­ures. But with a mar­ket worth bil­lions of dol­lars, the chase con­tin­ues.

So­cial im­age: An­dreas Arnold, AP Im­ages

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.