Biotech startup lines up more cash to steer its NASH drug through stormy seas

Rob De Ree, NorthSea Therapeutics CEO (Biogeneration Ventures)

In Jan­u­ary 2020, Dutch NASH-fo­cused biotech North­Sea Ther­a­peu­tics raised $40 mil­lion in a Se­ries B to progress its lead can­di­date icos­abu­tate, a struc­tural­ly-en­gi­neered fat­ty com­pound for NASH. Just shy of two years lat­er, North­Sea has com­plet­ed an­oth­er round of fi­nanc­ing, net­ting a $80 mil­lion Se­ries C to start a Phase III in NASH and ad­vance sev­er­al oth­er can­di­dates.

The biotech an­nounced the raise ear­ly this morn­ing, which was co-led by Ys­ios Cap­i­tal and For­bion Growth, and joined by new in­vestor Her­cules Cap­i­tal. Some of the ex­ist­ing in­vestors that hopped on­to the round in­clud­ed No­vo Seeds and Sofinno­va, ac­cord­ing to North­Sea.

Start­ed back in late 2017 by ex-Dez­i­ma CEO Rob de Ree with just over $28 mil­lion in cap­i­tal to de­vel­op an oral drug for NASH, icos­abu­tate — in-li­censed from Prono­va Bio­Phar­ma — had al­ready shown to be safe and ef­fec­tive in two pre­vi­ous Phase II clin­i­cal tri­als, North­Sea said back in 2017. Those two tri­als were for hy­per­triglyc­eridemia, a com­mon con­di­tion where a high lev­el of triglyc­erides (a cer­tain type of fat) is present in the blood.

North­Sea dosed its first pa­tient in Sep­tem­ber 2019 as part of the ICONA tri­al — a 62 week-long, Phase IIb tri­al test­ing icos­abu­tate in more than 200 pa­tients. The biotech an­nounced this morn­ing that it just fin­ished en­rolling pa­tients for the tri­al, set­ting the num­ber at 264.

The funds will push for­ward a few of North­Sea’s drug can­di­dates fur­ther in­to clin­i­cal tri­als, it said in a state­ment. Out­side of icos­abu­tate, it has three oth­er pro­grams: SE­FA-1024 for dys­lipi­demia (cur­rent­ly in a Phase I study), SE­FA-6179 in a new­ly-start­ed Phase I tri­al for in­testi­nal fail­ure as­so­ci­at­ed liv­er dis­ease and SE­FA-6131, which is still in pre­clin­i­cal test­ing for fa­mil­ial chy­lomi­crone­mia syn­drome, a ge­net­ic dis­or­der.

The biotech said it will start prepar­ing next year for icos­abu­tate to en­ter Phase III — in an­tic­i­pa­tion for top line re­sults from the Phase IIb tri­al in the first quar­ter of 2023.

Over the last few years, the first wave of NASH drug de­vel­op­ers has strug­gled with both safe­ty and ef­fi­ca­cy. When Gold­man Sachs pre­dict­ed that 2019 would be ‘The Year of NASH,’ that pre­dic­tion didn’t just fall flat — it sloped down­wards as 2019 showed a ca­coph­o­ny of fail­ures in the biotech in­dus­try.

Gilead failed two large Phase III tri­als; CymaBay’s share price crashed from over $13 a share in ear­ly 2019 to un­der $2 a share af­ter they found their drug ap­peared to be mak­ing pa­tients worse in one study; and Cir­ius with­drew an $86 mil­lion IPO bid af­ter a fate­ful read­out in their mas­sive, 400+ pa­tient Phase IIb tri­al. Just in 2019.

Fast for­ward to 2020 and 2021, and it’s a sim­i­lar trend. In­ter­cept’s drug obeti­cholic acid has been plagued with dif­fer­ent is­sues: The drug got hit with a CRL in June 2020 for a NASH in­di­ca­tion, and was then re­strict­ed by the FDA ear­li­er this year in an­oth­er in­di­ca­tion be­cause of se­vere liv­er dam­age in pa­tients with ad­vanced cir­rho­sis. Gen­fit threw in the tow­el last Ju­ly on NASH af­ter a mas­sive Phase III fail­ure on its drug can­di­date elafi­bra­nor — which iron­i­cal­ly was just bought to­day by fel­low French biotech Ipsen in a $575 mil­lion deal.

While the field of pro­grams ded­i­cat­ed for NASH is lit­tered with fail­ures, that doesn’t mean biotechs aren’t still try­ing. GSK paid Ar­row­head $120 mil­lion up­front and over $900 mil­lion in mile­stones on Ar­row­head’s RNA drug in No­vem­ber, a risky bet to maybe turn out the first func­tion­al NASH drug.

All that said, eyes are on North­Sea to see how icos­abu­tate does in Phase II and whether it can do what no oth­er drug has yet — or if it will bite the dust like most of its pre­de­ces­sors.

Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

Richard Pazdur (via AACR)

There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.

‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.

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Remember the sandwich generation? That’s the group of middle-aged people who are caring for both children and aging parents.

It’s a group that pharma companies often market to directly as parents who are making decisions about vaccinations, routine visits or rare conditions, but less often in their roles as caregivers who are making healthcare decisions for older family members.

But maybe they should.

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A Chrysalis Initiative and Intouch Solutions campaign features art depictions of Black women with a white not-equal sign drawn over to point out disparity in breast cancer care.

Jamil Rivers went from metastatic breast cancer patient to advocate to non-profit founder – all in her pursuit of breast cancer healthcare equity for Black women. Her mission began a few years ago when at age 39, she was diagnosed with metastatic breast cancer. As she navigated her care and the health system, she was shocked to find out that Black women die from breast cancer at a 40% higher rate than white women.

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American children under the age of five may not be vaccinated until mid-2022, as Pfizer said Friday that it’s going to now test a third dose of its Covid-19 vaccine in the trial.

The decision comes as Pfizer announced non-inferiority was not met for children between the ages of two and five when compared to older teenagers in the current trial.

Pfizer previously said it might apply for an EUA in this youngest population by the end of December or early next year, but now says that if the three-dose study proves successful, Pfizer and BioNTech expect to submit data to regulators to support an EUA ‘in the first half of 2022.’

The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.

The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.

Well, Purdue Pharma’s multi-billion dollar opioid settlement is now in jeopardy — a federal judge just said no.

Colleen McMahon, a judge on the US District Court for the Southern District of New York, said that the settlement, which would dissolve Purdue Pharma and was approved in September by a bankruptcy judge, should not go forward because it releases the company’s owners, members of the billionaire Sackler family, from liability in civil opioid-related cases.

Usama Malik, ex-Immunomedics CFO

A couple weeks after facing insider trading allegations, former Immunomedics CFO Usama Malik responded to the charges in a vaguely worded LinkedIn post reflecting on the moment when his ‘world was upended.’

Malik was charged on Dec. 2 over allegations that he tipped off his then-girlfriend and four others that a Phase III study for Immunomedics’ breast cancer drug Trodelvy would be stopped early, the Department of Justice said in a complaint. Those individuals went on to purchase more than 9,000 Immunomedics shares, with one of them selling those shares right after the news broke and the biotech’s stock price doubled.

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Otello Stampacchia, Omega

Amid a very difficult back half of the year for biotech investing, some bullish investors are making the case for a major rally in the coming year as pharma looks to utilize its growing mountain of cash. Now, biotech blue-chipper Omega Funds is getting itself set at the starting line.

Omega has closed a $650 million investment fund it’s calling Omega Fund VII, the VC firm’s latest and largest round in its 17 years in existence, it said Friday.

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