Jay Venkatesan, Angion CEO

An­gion, still reel­ing from past de­feats, scraps a PhII kid­ney dis­ease study af­ter 'un­ex­pect­ed' safe­ty event

Faced with a litany of set­backs over its lead pro­gram last year, An­gion Bio­med­ica is now re­port­ing a new ob­sta­cle in a fol­low-up can­di­date.

An­gion is dis­con­tin­u­ing a Phase II tri­al eval­u­at­ing oral TKI in­hibitor ANG-3070, the com­pa­ny said Wednes­day af­ter­noon, af­ter an un­ex­pect­ed safe­ty is­sue popped up in the study’s treat­ment arm. Re­searchers had been en­rolling pa­tients with se­ri­ous kid­ney dis­eases, in­clud­ing fo­cal seg­men­tal glomeru­loscle­ro­sis (FS­GS) and im­munoglob­u­lin A nephropa­thy (IgAN).

“We be­lieve it to be in the best in­ter­est of pa­tients to dis­con­tin­ue our Phase II JU­NIPER study at this time, notwith­stand­ing the sig­nif­i­cant un­met need for new ther­a­pies in this pa­tient pop­u­la­tion,” CEO Jay Venkate­san said in a state­ment. “We are, of course, dis­ap­point­ed by to­day’s an­nounce­ment and have made the de­ci­sion to de­pri­or­i­tize the study.”

In­vestors re­act­ed neg­a­tive­ly to the news, send­ing An­gion shares $ANGN down 17% pre-mar­ket to about $1.41 apiece.

The biotech had been en­rolling pa­tients since De­cem­ber. An­gion said it de­cid­ed to scrap the tri­al af­ter see­ing an “un­ex­pect­ed and sub­stan­tial de­cline” in one pa­tient’s kid­ney func­tion. While re­searchers did not point to one cause specif­i­cal­ly, they not­ed a re­view of all the da­ta, in­clud­ing blind­ed da­ta and TKI drug class side ef­fects, led to Wednes­day’s move.

Though ANG-3070 hadn’t orig­i­nal­ly been An­gion’s lead clin­i­cal pro­gram, it was anoint­ed the po­si­tion by de­fault af­ter a num­ber of set­backs for the biotech’s or­gan-dam­age drug. Last Oc­to­ber, An­gion re­port­ed a can­di­date for high-risk kid­ney trans­plant pa­tients dubbed ANG-3777 flopped in a piv­otal Phase III study, just a few months af­ter a big miss in Covid-re­lat­ed ARDS.

Then in De­cem­ber, ANG-3777 missed its pri­ma­ry end­point in an­oth­er Phase II tri­al, ef­fec­tive­ly end­ing its path to the FDA. An­gion has since said it doesn’t plan to con­tin­ue de­vel­op­ment here, but as of this May’s first quar­ter re­port, is still work­ing with its part­ner Vi­for Phar­ma to de­ter­mine the best course for­ward.

Al­though those set­backs had al­ready left ANG-3070 as the com­pa­ny’s sole clin­i­cal can­di­date, Wednes­day’s de­vel­op­ment push­es the pro­gram back even fur­ther. An­gion is plan­ning to eval­u­ate the drug in id­io­path­ic pul­monary fi­bro­sis, but on­ly just re­ceived IND clear­ance last month.

A Phase Ib study for IPF is ex­pect­ed to start en­rolling pa­tients some­time lat­er this year, An­gion says.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Harpreet Singh, Immatics CEO

Im­mat­ics an­nounces mul­ti­ple pipeline changes with lat­est fi­nan­cial re­sults

The T-cell biotech Immatics is looking to make some changes to its pipeline.

Immatics released its 2022 financial results on Tuesday and announced that it’s planning to discontinue its program for IMA201, an experimental cell therapy for solid tumors that express the antigens known as MAGE4/8. It plans to shift focus to IMA401, a TCR bispecific which goes after the same target.

The German-based biotech said it will treat the remaining patients enrolled in the program before the discontinuation. No other reasons were given for the discontinuation. Endpoints News reached out to Immatics for more details but did not receive a response by press time.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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