Rivus Pharmaceuticals CEO Allen Cunningham (L) and CSO Shaharyar Khan

Weight loss play­er gets at­ten­tion of RA Cap­i­tal, walks away with $132M to keep pur­su­ing big tar­gets

A biotech out  to cor­ner a new mar­ket in the di­a­betes and weight loss space has record­ed its sec­ond, and so far largest, raise yet.

Char­lottesville, VA-based Rivus Phar­ma­ceu­ti­cals made the an­nounce­ment Thurs­day that it has closed its Se­ries B at $132 mil­lion. Led by RA Cap­i­tal, the round will push the biotech fur­ther along in clin­i­cal de­vel­op­ment of its lead can­di­date, HU6. Per Rivus, the lead can­di­date is a type of small mol­e­cule called a “con­trolled meta­bol­ic ac­cel­er­a­tor,” a term the biotech coined to de­scribe a drug de­signed to tar­get obe­si­ty — by in­creas­ing the num­ber of calo­ries a pa­tient burns.

As CEO Allen Cun­ning­ham and CSO Sha­har­yar Khan tell End­points News, Rivus is look­ing at in­creas­ing en­er­gy ex­pen­di­ture phar­ma­co­log­i­cal­ly to re­duce obe­si­ty, in­stead of fo­cus­ing more on re­duc­ing caloric in­take.

“You’ve got en­er­gy com­ing in, caloric in­take, and then you’ve got en­er­gy go­ing out — caloric ex­pen­di­ture. And most of these ap­proach­es that are see­ing this, the obe­si­ty ther­a­peu­tics are tar­get­ing that front end, the caloric in­take side of the equa­tion,” Khan said.

So far, the biotech has al­ready cleared its lead can­di­date in obe­si­ty through Phase IIa, read­ing out ear­li­er this year and show­ing that the drug helped pa­tients lose a to­tal of six pounds of fat over the course of two months.

And as part of the raise, Rivus is con­tin­u­ing a sec­ond Phase IIa study that the biotech re­cent­ly start­ed in obese par­tic­i­pants with heart fail­ure with pre­served ejec­tion frac­tion (HF­pEF), as well as start­ing a Phase IIb in obe­si­ty — a 12-month-long study that is slat­ed to start some­time next year and have a sub­set of pa­tients with type II di­a­betes.

On top of those in­di­ca­tions, the biotech has al­so been look­ing at se­vere hy­per­triglyc­eridemia (SHTG) and NASH, which has been a prover­bial mine­field with­out many pos­i­tive read­outs over the years.

The Rivus ex­ecs said that they’re now ful­ly fund­ed through 2024 as the biotech plans to run two clin­i­cal tri­als si­mul­ta­ne­ous­ly. And while head­count is still small, a few hires are planned, the ex­ecs not­ed.

The CSO added that the key mech­a­nism they’re try­ing to lever­age is mi­to­chon­dr­i­al un­cou­pling, a nat­ur­al process in the body where cel­lu­lar en­er­gy trans­port mech­a­nisms are di­vert­ed to be used out­side their nor­mal func­tion of syn­the­siz­ing adeno­sine triphos­phate, or ATP. Nor­mal­ly, mi­to­chon­dria take sub­strates, fats and sug­ars and gen­er­ate en­er­gy as a byprod­uct. If that process gets slowed down, the body has to burn more calo­ries to get its en­er­gy be­fore it can re­turn to en­er­gy bal­ance.

Rivus says its lead can­di­date al­so is fat-se­lec­tive, forc­ing the body to burn fat in­stead of oth­er mol­e­cules to sur­vive. Part of the perks be­hind go­ing on­ly af­ter fat, Cun­ning­ham says, is that skele­tal mass re­mains in­tact.

“Af­ter a caloric deficit, the first thing you gain back is fat. And once you lose that skele­tal mus­cle mass, it’s hard to get it back,” Cun­ning­ham added.

As for next fi­nanc­ing plans, con­sid­er­ing RA Cap­i­tal’s pre­vi­ous habit of back­ing com­pa­nies in prepa­ra­tion for an IPO, ex­ecs de­clined to an­swer — but not­ed that as part of the fi­nanc­ing, they will be look­ing more in­to new in­di­ca­tions and bring­ing a new CMA can­di­date in­to its pipeline.

“We are look­ing at where the sci­ence is high­ly sup­port­ive, whether it’s in ar­eas like can­cer or neu­rode­gen­er­a­tion, or even ag­ing,” Khan not­ed.

The biotech got its start in March 2019, se­cur­ing $35 mil­lion via a Se­ries A round — but re­mained in stealth mode un­til it emerged just over two years lat­er.

Oth­er in­vestors that tagged along on to­day’s Se­ries B in­clud­ed new in­vestors Bain Cap­i­tal Life Sci­ences and BB Biotech, plus pre­vi­ous back­ers Lon­gi­tude Cap­i­tal, Medicxi and Rx­Cap­i­tal.

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.

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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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 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.

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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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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

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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