Tar­sus nabs key da­ta in hunt to re­pur­pose dog drug as cure for eye par­a­site

Eight months af­ter their $101 mil­lion IPO, Tar­sus Phar­ma­ceu­ti­cals say they’ve cleared the first of two tri­als need­ed to prove to their FDA that their re­pur­posed dog drug can suc­cess­ful­ly ban­ish mites from pa­tients’ eyes.

The Cal­i­for­nia biotech an­nounced Mon­day that, in a Phase II/III study, 81% of pa­tients with the com­mon eye in­fes­ta­tion De­mod­ex ble­phar­i­tis achieved a “clin­i­cal­ly mean­ing­ful” cure of in­fes­ta­tion-in­duced le­sions af­ter tak­ing the drug, called TP-03. That com­pared to 23% of pa­tients on place­bo. And, on the sec­ondary end­point, 68% of pa­tients saw their mites erad­i­cat­ed en­tire­ly — com­pared to 18% on place­bo.

If the da­ta hold up in a Phase III tri­al ex­pect­ed to read out next year, the com­pa­ny will ap­ply for FDA ap­proval. They es­ti­mate that be­tween 9 mil­lion and 25 mil­lion Amer­i­cans suf­fer from the dis­ease, which can trig­ger dam­ag­ing in­flam­ma­tion and ir­ri­ta­tion around the eye­lid.

Bobak Aza­mi­an

“Mil­lions of peo­ple are liv­ing with De­mod­ex ble­phar­i­tis, and we know from re­cent re­search that these pa­tients are suf­fer­ing dai­ly,”  CEO Bobak Aza­mi­an said in a state­ment. “We be­lieve the re­sults from our Sat­urn-1 tri­al mark an im­por­tant mo­ment in De­mod­ex ble­phar­i­tis re­search, show­ing the po­ten­tial of TP-03 to tar­get the un­der­ly­ing cause of this dis­ease and po­ten­tial­ly be­come the stan­dard of care for pa­tients and clin­i­cians.”

The com­pa­ny’s lead drug is a ver­sion of a com­mon vet­eri­nary drug loti­lan­er, of­ten used to pre­vent tick and flea in­fes­ta­tions in dogs. Tar­sus sub-li­censed the mol­e­cule from pet health gi­ant Elan­co in 2019 and re­for­mu­lat­ed it: Rather than a chewy, beef-fla­vored tablet, the mol­e­cule would come in clear (pre­sum­ably fla­vor­less) eye drops.

The Sat­urn-1 tri­al is their fifth to test loti­lan­er on De­mod­ex ble­phar­i­tis. The study en­rolled 421 pa­tients who had more than 10 col­larettes — waxy le­sions near the eye that are a hall­mark of the dis­ease — and mild red­den­ing. In ad­di­tion to the end­points on col­larettes and mite erad­i­ca­tion, 68% of pa­tients saw both their col­larette and red­ness di­min­ish strong­ly. Just over 13% saw both van­ish en­tire­ly.

The most com­mon side ef­fect was pain, burn­ing or sting­ing at the ad­min­is­tra­tion site; 11.8% of pa­tients re­port­ed it.

The com­pa­ny is al­so de­vel­op­ing an oral form of the drug for Ly­me dis­ease and malar­ia.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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