Grace Colón, InCarda CEO

With its eyes set on an IPO raise, In­Car­da un­rolls mid-stage da­ta back­ing in­haled ar­rhyth­mia drug

Work­ing to craft an old ar­ry­th­mia drug in­to a more user-friend­ly in­haled for­mu­la­tion, In­Car­da is ex­pect­ing to use new Phase II da­ta re­vealed Wednes­day as the foun­da­tion of a po­ten­tial IPO raise.

The pro­gram, re­pur­pos­ing the oral and IV drug fle­cainide in­to an in­halant, com­plet­ed the lat­est co­hort of its Phase II study with 50% of pa­tients suc­cess­ful­ly con­vert­ing their ir­reg­u­lar heart­beat episodes back to nor­mal rhythm with­in 90 min­utes, the San Fran­cis­co biotech said. That end­point will be the pri­ma­ry goal in a piv­otal Phase III study, ex­pect­ed to be­gin by the end of Sep­tem­ber.

And In­Car­da be­lieves the da­ta are strong enough to get a pos­si­ble IPO ready, as the biotech hired a CFO in con­junc­tion with the news. CEO Grace Colón told End­points News that In­Car­da is in the midst of rais­ing funds for a $70 mil­lion crossover round, and will ex­plore a jump to Nas­daq “should it make sense.”

So far in 2021, 65 biotechs have filed or priced their IPOs, ac­cord­ing to the End­points tal­ly.

Wednes­day’s da­ta come from a study eval­u­at­ing the fle­cainide neb­u­liz­er in a med­ical­ly su­per­vised set­ting, look­ing at in­di­vid­u­als with re­cent-on­set parox­ys­mal atri­al fib­ril­la­tion, or PAF. Pa­tients have been clam­or­ing for new treat­ments, Colón said, be­cause they typ­i­cal­ly re­ceive rate-con­trol­ling treat­ments in emer­gency rooms or oth­er set­tings when they ex­pe­ri­ence PAF episodes, rather than rhythm-con­trol­ling drugs.

“Things with high heart rate like 120 to 160 beats per minute, that’s just fast heart rate pal­pi­ta­tions,” Colón told End­points. “But they al­so ex­pe­ri­ence skipped beats and dizzi­ness, like they can’t breathe. When their heart is not beat­ing nor­mal­ly, they can get se­vere anx­i­ety. It’s a spe­cif­ic type of symp­toms.”

The on­ly cur­rent­ly ap­proved drug to treat these episodes, in­tra­venous ibu­tilide, on­ly has a 90-minute con­ver­sa­tion rate of 38% to 40%, In­Car­da says. Not on­ly did In­Car­da’s pro­gram hit the 50% mark in the Phase II study, but Colón said the mean time of con­ver­sion was just eight min­utes.

Ad­di­tion­al­ly, 72% of those whose heart­beats re­turned to nor­mal rhythm did so with­in the first half hour af­ter treat­ment.

Colón ex­pects much of the new crossover to be di­rect­ed to­ward the Phase III study, which is seek­ing to en­roll 400 pa­tients. Re­searchers are plan­ning to ran­dom­ize pa­tients to the drug arm at a 3-to-1 ra­tio with that 90-minute con­ver­sion rate as the pri­ma­ry, and will al­so check out a host of sec­ondary end­points such as re­lief of symp­toms, hos­pi­tal­iza­tions and time to dis­charge, among oth­ers.

In­Car­da is al­so con­duct­ing stud­ies for the drug in a self-ad­min­is­tered set­ting, with a cur­rent­ly on­go­ing Phase II, and is work­ing on a tri­al for re­peat use. Ini­tial ob­ser­va­tions in­di­cate that pa­tients who re­spond to their first use of the can­di­date be­come “very like­ly” to have a sec­ond re­sponse should an­oth­er episode pop up, Colón said.

There’s been lots of cul­tur­al aware­ness around this is­sue, she added, help­ing dri­ve In­Car­da’s re­search for­ward. Heart rate and rhythm track­ing tech­nol­o­gy has sprout­ed up every­where in wear­able prod­ucts like the Ap­ple Watch, mak­ing it even eas­i­er for pa­tients to keep track of their PAF episodes. In­Car­da has had ear­ly dis­cus­sions with com­pa­nies de­vel­op­ing some of these prod­ucts and will con­tin­ue look­ing for a part­ner should the piv­otal tri­al work out.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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