Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clin­i­cal stud­ies back on track amid the pan­dem­ic, Med­able re­turned to the ven­ture well for the sec­ond time this year, bag­ging a $91 mil­lion Se­ries C to build out its vir­tu­al tri­al plat­form.

The soft­ware provider re­cent­ly launched three new apps for de­cen­tral­iz­ing clin­i­cal tri­als, and saw a 500% rev­enue spike this year. And it isn’t alone. Back in Au­gust, Sci­ence 37 se­cured a $40 mil­lion round for its vir­tu­al tri­al tech, with sup­port from No­var­tis, Sanofi Ven­tures and Am­gen. Pa­tients and re­searchers are tak­ing a lik­ing to the on­line ap­proach, sug­gest­ing reg­u­la­tors could al­low it to be­come a new nor­mal even af­ter the pan­dem­ic is over.

“The pan­dem­ic has made the world aware of the im­por­tance of clin­i­cal drug de­vel­op­ment,” Med­able CEO Michelle Long­mire said in a state­ment.

De­cen­tral­ized tri­als are sim­ply more con­ve­nient — vol­un­teers can pick up a phone to par­tic­i­pate, rather than risk­ing a vis­it to a clin­i­cal tri­al site, many of which are op­er­at­ing un­der re­stric­tions amid the pan­dem­ic.

Ac­cord­ing to a Glob­al­Da­ta poll post­ed in Sep­tem­ber, 67% of health ex­perts sur­veyed said they plan on con­duct­ing de­cen­tral­ized clin­i­cal tri­als due to Covid-19. Ac­cord­ing to Med­able, its cus­tomers are re­port­ing faster pa­tient en­roll­ment and in­creased re­ten­tion rates.

Parax­el, an­oth­er vir­tu­al tri­al play­er, said tri­als us­ing “pa­tient-cen­tric de­signs” take less time to re­cruit the first 100 pa­tients — an av­er­age of 4 months ver­sus 7 for all tri­als.

“Many da­ta sources re­port that pa­tients trav­el, on av­er­age, 30 miles to their re­search clin­ic, which adds a sig­nif­i­cant time and ef­fort bur­den, which is fur­ther am­pli­fied for frag­ile and vul­ner­a­ble pa­tients,” Med­able SVP of mar­ket­ing David Swanger said in an emailed state­ment. “As we have all be­come more com­fort­able with man­ag­ing oth­er as­pects of our lives on­line, such as bank­ing and shop­ping, then it is rea­son­able we would like to ex­tend that abil­i­ty and con­ve­nience to health­care par­tic­i­pa­tion, par­tic­u­lar­ly clin­i­cal tri­als.”

This year, the Pa­lo Al­to, CA-based com­pa­ny launched Tele­Vis­it, which con­nects pa­tients with site co­or­di­na­tors and in­ves­ti­ga­tors; Tele­Con­sent, which al­lows pa­tients to vir­tu­al­ly con­sent and re-con­sent to clin­i­cal tri­als; and Tele­COA, which com­bines elec­tron­ic Clin­i­cal Out­come As­sess­ments (eCOAs) with Tele­Vis­its. It al­so struck part­ner­ships with Data­vant, AliveCor and MRN.

“We’re ex­cit­ed to break down yet an­oth­er bar­ri­er, and stream­line the path to greater par­tic­i­pant di­ver­si­ty, ac­cess, and en­gage­ment,” Long­mire said.

Since its found­ing in 2015, Med­able has raised more than $136 mil­lion. The Se­ries C was led by Sap­phire Ven­tures, with a hand from GSR Ven­tures and Stream­lined Ven­tures — the lat­est and like­ly not the last in­vestors to bet on a vir­tu­al fu­ture for clin­i­cal tri­als.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.