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.

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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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.