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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.