Arde­lyx rolls out pos­i­tive PhI­II IBS-C da­ta on tena­panor as ri­vals prep for a show­down, but shares crater

Two days ago it was Syn­er­gy Phar­ma’s turn to tout pos­i­tive Phase III da­ta on its drug Tru­lance for ir­ri­ta­ble bow­el syn­drome with con­sti­pa­tion. To­day, ri­val Arde­lyx $ARDX is step­ping up with the first of its two Phase III read­outs on tena­panor as the new­com­ers look to chal­lenge Iron­wood’s mar­ket-lead­ing ther­a­py. And at first blush, in­vestors weren’t im­pressed.

All but one of the key da­ta points were all pos­i­tive. In the pri­ma­ry goal, ob­serv­ing the im­pact of their drug in 6 of 12 weeks of ther­a­py, 27% in the tena­panor arm scored a com­plete re­sponse on a sig­nif­i­cant 30% or greater re­duc­tion in ab­dom­i­nal pain and at least one added com­plete bow­el move­ment from base­line — com­pared to 18.7% in the place­bo group.

Mike Raab

There was a key sec­ondary miss, though, on in­di­vid­ual bow­el move­ment rates. Di­ar­rhea could al­so prove trou­ble­some for Arde­lyx, with a rel­a­tive rate of 14.6% for the drug arm vs 1.7% in the place­bo group. 5.9% of the pa­tients tak­ing tena­panor dis­con­tin­ued due to di­ar­rhea, but Arde­lyx CEO Mike Raab has been hit be­fore on di­ar­rhea rates for this drug, and an­a­lysts are like­ly to be re­lieved the rate wasn’t high­er.

Wed­bush’s David Nieren­garten looked the da­ta over and con­clud­ed that the drug looked ap­prov­able, but not a top per­former, land­ing “some­where in be­tween Linzess and Tru­lance (gen­er­al­ly not as ef­fi­ca­cious as Linzess or as well-tol­er­at­ed as Tru­lance). Al­though we view prod­uct as ap­prov­able (as­sum­ing suc­cess in T3MPO-2, read­ing out next half) the re­sults low­er our es­ti­mates and part­ner­ship in­ter­est for the drug, par­tic­u­lar­ly in light of the Tru­lance launch.”

That’s not what back­ers want­ed to hear, and the biotech’s stock cratered, plung­ing 32%.

You can be sure the ri­vals — in­clud­ing the team mar­ket­ing Iron­wood’s Linzess — will seize on any short­com­ings as they be­gin to square off over the mar­ket. Linzess has scored the high­est of the three on ef­fi­ca­cy (34%), with Arde­lyx trail­ing in third place, though all are with­in a few points of each oth­er. Linzess may have the worst rate for di­ar­rhea.

None of these drugs stand out as a dom­i­nant drug on ef­fi­ca­cy, and that may well lead to a near fu­ture sce­nario in which physi­cians send pa­tients home with a sam­pling so they can de­cide which is best for them.

Tru­lance (ple­ca­natide) in­ves­ti­ga­tor Ronald Fo­gel told me ear­li­er in the week that that is what they do in his prac­tice.

David Rosen­baum

“When we look at the to­tal­i­ty of the topline re­sults from T3MPO-1, we be­lieve tena­panor has the po­ten­tial to of­fer ben­e­fit to pa­tients with IBS-C,” said David Rosen­baum, chief de­vel­op­ment of­fi­cer at Arde­lyx. “We are en­cour­aged that the nine of 12 week da­ta demon­strate a durable and sus­tained re­sponse for con­sti­pa­tion and ab­dom­i­nal pain, as well as a nor­mal­iza­tion of bow­el move­ment fre­quen­cy, for many pa­tients. The in­di­vid­ual CS­BM re­spon­der rate from the six of 12 week analy­sis was the one sec­ondary end­point not met and those da­ta are not con­sis­tent with the re­sults from our pre­vi­ous clin­i­cal stud­ies. We plan to as­sess these da­ta along­side the re­sults from T3MPO-2, our six-month Phase 3 study, to eval­u­ate the to­tal ben­e­fit that tena­panor may pro­vide to pa­tients with this ex­treme­ly chal­leng­ing con­di­tion.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: Searching the Pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially,early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.