Bobak Azamian, Tarsus CEO

UP­DAT­ED: Tar­sus to raise $75.6M for re­pur­posed dog drug that's head­ed to FDA af­ter eye drop's PhI­II win

Tar­sus Phar­ma­ceu­ti­cals will ship its eye drop off to the FDA be­fore year’s end in the hopes of se­cur­ing the first reg­u­la­to­ry nod for a treat­ment for De­mod­ex ble­phar­i­tis, or eye­lid mange, af­ter a Phase III da­ta drop Mon­day and said it will seek $50 mil­lion in a pub­lic of­fer­ing to fu­el it.

The biotech up­sized the pub­lic of­fer­ing to $75.6 mil­lion on Tues­day. The com­pa­ny lost 23.5% of its stock $TARS val­ue by the clos­ing bell on Mon­day, slip­ping to $14 per share.

“This is a tri­al that re­al­ly hasn’t been con­duct­ed by any­one be­fore, a De­mod­ex ble­phar­i­tis piv­otal,” CEO Bobak Aza­mi­an told End­points News.

With Phase III re­sults in hand, the Irvine, CA biotech will seek an FDA green light, ad­vance the drug in­to a Phase III with part­ner Lian­Bio in Chi­na and form sim­i­lar part­ner­ships in Eu­rope, Japan and else­where across Asia, the CEO said.

The biotech’s eye drop was able to com­plete­ly cure the num­ber of in­fes­ta­tion-in­duced le­sions, de­fined as 0 to 2 per lid, in 56% of pa­tients at day 43, com­pared to 13% on place­bo. The drug, dubbed TP-03, led to a “sig­nif­i­cant, clin­i­cal­ly mean­ing­ful col­larette cure,” de­fined as grade 0 or 1, in 89% of pa­tients ver­sus 33% of those on place­bo at day 43.

Col­larettes “are ba­si­cal­ly com­posed of de­com­pos­ing mites. They’re a re­sult of the mites that bub­ble up and form this waxy plaque at the base of the eye­lash­es,” Aza­mi­an said.

Mite erad­i­ca­tion, or 0 per lash, was achieved in 52% of pa­tients, com­pared to 14% on place­bo. That Phase III re­sult comes in be­low the Phase IIb study in which 68% of pa­tients saw mites erad­i­cat­ed en­tire­ly. Both stud­ies en­rolled more than 400 pa­tients, with the Sat­urn-2 tri­al be­ing con­duct­ed at 21 sites across the US and com­menced be­fore the Phase IIb re­sults even came in be­cause of the biotech’s con­fi­dence in the eye drop.

The treat­ment was de­liv­ered for six weeks be­cause that’s what the FDA want­ed to see based on oth­er eye drops and an­ti-in­fec­tive ex­pe­ri­ence, Aza­mi­an said.

“It works well for the bi­ol­o­gy be­cause a mite life cy­cle is about two weeks. There’s dif­fer­ent forms of mites — eggs, nymphs, adult mites, so you want to treat about two or three life cy­cles, so we knew that we’d want to treat for at least a month,” he said.

The drug al­so led to com­plete red­ness cure, a sec­ondary end­point, in 31% of pa­tients com­pared to 9% in the place­bo group.

“Think about lid red­ness as some­thing pa­tients no­tice, not just an ob­jec­tive sign, but al­so some­thing be­yond mites and col­larettes. So in­flam­ma­tion im­prov­ing and be­ing cured, and that’s very rarely seen with any eye drops, even pow­er an­ti-in­flam­ma­to­ries. So that re­al­ly pro­vides, I think, a broad­er clin­i­cal val­i­da­tion of our treat­ment to pa­tients, doc­tors and ul­ti­mate­ly to pay­ers, as well,” Aza­mi­an said.

TP-03 is a re­pur­posed, eye drop for­mu­la­tion of loti­lan­er, a com­mon tick and flea drug, usu­al­ly in tablet form, for dogs. Tar­sus has test­ed the new for­mu­la­tion in about half a dozen hu­man stud­ies since sub-li­cens­ing it from pet health gi­ant Elan­co in 2019.

In terms of TP-03’s safe­ty pro­file, the eye drop led to in­stil­la­tion site pain/burn­ing/sting­ing in 7.9% of pa­tients. “If you com­pare to some­thing like Resta­sis, those rates are 20% plus,” the CEO said, re­fer­ring to Ab­b­Vie’s Al­ler­gan eye drop for chron­ic dry eye.

Az­iz Mot­ti­wala

And Resta­sis is a drug that Tar­sus knows well. The biotech’s chief com­mer­cial of­fi­cer, Az­iz Mot­ti­wala, was a VP of mar­ket­ing at Al­ler­gan and over­saw the ramp up of Resta­sis. At Tar­sus, he has the po­ten­tial to lead the launch of a drug that Aza­mi­an has said could im­pact 25 mil­lion Amer­i­cans.

“He came here be­cause he saw the op­por­tu­ni­ty to do it again and do it even bet­ter be­cause of the vi­su­al as­pects of this dis­ease,” Aza­mi­an said of Mot­ti­wala, who’s built out a sales team with VP lead­er­ship and oth­ers to se­cure mar­ket pres­ence, pend­ing ap­proval.

Asked about the bear mar­ket that Tar­sus could be launch­ing its drug in, Aza­mi­an re­ferred to the biotech’s $175 mil­lion cred­it fa­cil­i­ty that the com­pa­ny se­cured ear­li­er this year, giv­ing it run­way in­to the sec­ond half of 2024, or “well in­to our launch.”

“While of course, we’re not hap­py with our share price, we don’t re­al­ly wor­ry too much about it be­cause we have the run­way we need to make TP-03 a suc­cess,” the CEO said.

Af­ter rais­ing $88 mil­lion in its Oc­to­ber 2020 Wall Street de­but, Tar­sus $TARS has large­ly stayed above its $16 IPO pric­ing but has steadi­ly fall­en from its $49.62 peak in De­cem­ber 2020.

Tar­sus al­so snagged a part­ner last year to ex­pand the scope of TP-03, in a $15 mil­lion up­front deal with Shang­hai’s Lian­Bio.

“We have a con­fi­dent path there to ap­proval that will in­volve one more Phase III, which they will con­duct, start­ing lat­er this year,” Aza­mi­an said of Lian­Bio’s study in Chi­na. “And ob­vi­ous­ly with this Phase III un­der our belts, it gives every­one a lot more con­fi­dence in that. We’re hear­ing a lot of in­ter­est from oth­er ge­o­gra­phies.”

Japan, oth­er parts of Asia and Eu­rope are “re­gions we’re con­sid­er­ing next,” the CEO said.

Tar­sus is al­so ad­vanc­ing a cream for rosacea and a pill for Ly­me dis­ease and malar­ia.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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