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Sunday, September 1, 2019

Health tech funding: Insurtech Ethos lands $60M in GV-led round, Nurx $52M

Insurtech company Ethos snagged $60 million in funding in a Series C round led by GV (formerly Google Ventures), Alphabet’s venture arm, and backed by Goldman Sachs, the company announced on August 27.
The company, founded in 2016, is focused on disrupting the life insurance industry and uses predictive analytics and big data to issue life insurance policies. Existing investors Sequoia Capital and Accel also participated, bringing the total funding to-date to more than $100 million.
Ethos is now valued at nearly $500 million, Venture Beat reports.
Here’s a snapshot of other health IT funding deals over $5 million in August:
  • Prescription delivery: Health technology company Nurx, which sells prescription drugs including birth control online, closed a $52 million Series C funding round led by Kleiner Perkins Digital Growth Fund and Union Square Ventures.
    Investors Reproductive Health Investors Alliance, Dreamers VC, Lowercase Capital, and Y Combinator also participated in the funding round. The San Francisco-based company, founded in 2014, has raised more than $90 million in debt and equity funding to date, with the latest infusion bringing its valuation to nearly $300 million, according to TechCrunch.
  • Jobs marketplace: Nomad Health, an on-demand medical jobs marketplace that also advertises telemedicine positions, picked up $34 million in new equity and debt financing. Icon Ventures, a Palo Alto-based venture capital firm, led the financing with additional investment from prior investors Polaris Partners, RRE Ventures, .406 Ventures, and Silicon Valley Bank.
  • Healthcare data IT:  Startup MDClone, based in Israel, raised $26 million in Series B funding led by health tech venture capital fund aMoon and joined by earlier investors OrbiMed Israel Partners and Lightspeed Venture Partners. The company’s U.S. clients include Washington University School of Medicine in St. Louis, Intermountain Healthcare and the Regenstrief Institute.
  • Patient engagement: Luma Health landed $16 million in a Series B equity funding, bringing total equity funding to $25.7 million. Led by PeakSpan Capital and with strategic investments from Cisco Investments, the Texas Medical Center, and continued investment from U.S. Venture Partners, Luma Health will use the round of funding to scale and hire new staff.

  • AI diagnoses: Buoy Health, an online symptom checker that uses artificial intelligence to diagnose patients, closed a $15 million Series B funding round led by Hambrecht Ducera Growth Ventures. Health insurance company Humana joined the round as a strategic investor, and earlier backers F-Prime Capital (Fidelity Investments) and Optum Ventures also contributed.
  • Digital health tools: Hello Heart reeled in a $12 million Series B round led by Khosla Ventures to help bankroll the expansion of its sales and engineering teams, according to FierceBioTech.
  • Diagnostics platform: MIT-spinout Figur8 launched a digital platform to measure and track body movement as a biomarker with a boost in $7.5 million in seed funding. The company says its technology will help clinicians make better clinical decisions through advanced human movement data. Figur8’s diagnostics platform captures 3D skeletal movement in conjunction with muscle output to help trainers, therapists and physicians objectively measure musculoskeletal performance and recovery. The funding round was led by P5 Health Ventures, with participation from E14 Fund.

  • Surgery optimization: PeerWell developed a digital platform focused on addressing workers’ compensation surgery issues, from pain management and surgery avoidance to surgery optimization and guided recovery. The company picked up $6.5 million in a Series A funding round. The funding was led by OMERS Ventures, with participation from XSeed Capital. The funding will help the company fast-track the commercial rollout of a new platform focused on musculoskeletal surgery therapy.
  • Breathalyzer: Also, a reserve deputy sheriff and SWAT team member, Mike Lynn, who also is an emergency room doctor and former biotech venture capitalist, started a company called Hound Labs that is working on the first dual marijuana and alcohol breathalyzer. Hound Labs raised $30 million in a Series D financing round. Intrinsic Capital Partners led the round, with investors NFP Ventures and Main Street Advisors also contributing, as well as existing backers Icon Ventures and Benchmark.
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July was a bright spot for hospital volumes after rough June — Kaufman Hall

In July, the consulting company’s August 2019 National Flash Report of metrics from more than 600 hospitals showed health systems saw discharges, emergency department visits and adjusted volume metrics improved about 3% to 4% from the previous month.
After a rather lackluster financial performance in June, U.S. hospitals appeared to bounce back in July thanks to an unexpected uptick in inpatient and emergency department volumes, a new report from Kaufman Hall found.
In general, over the last year Kaufman Hall has seen institutions largely responding well to the larger trend of reducing inpatient volumes and managing their cost structures accordingly, Managing Director Jim Blake told FierceHealthcare.
But “what we saw last month was a little bit of the wheels falling off the bus,” Blake said. “We saw the volume decreases were bigger, the profitability on the month-over-month and year-over-year bases were much worse. We saw institutions, on average, not handling it. It was a pretty bad month.”

Then, in July, the consulting company’s August 2019 National Flash Report of metrics from more than 600 hospitals showed health systems saw discharges, emergency department visits and adjusted volume metrics improved about 3% to 4% from the previous month. Operating room minutes rose 8.1%, and adjusted patient days were up 4.5%.
“Just as June was unexpectedly bad, July was unexpectedly good,” Blake said.
While that unexpected bump was good news for hospitals, it also indicates many of these organizations—particularly the largest and smallest hospitals—don’t have the ability to flex with the shorter-term market fluctuations, said Kaufman Hall Vice President Erik Swanson.
“When we look at how hospitals respond to some of those factors that they cannot control, like volumes, what we’ve been seeing as an overall trend is the inability to necessarily flex particularly well with volumes,” Swanson said. “What we saw in June and what we’ve seen as a trend over the last year or so is at many of these organizations, as volumes decrease on the inpatient side, their profitability in general decreases. When the volumes increase, they tend to do pretty well.”
Beyond that, while Swanson said there have been continued indicators of more efficient management of labor expenses, those efficiencies appear to be slowing in recent months.

“The rate of that decrease is slowing meaning that many of those organizations are starting to get less juice for the squeeze in some of that because their beginning to hit those limits of traditional blocking and tackling of labor management and its not until they move to some more data-driven approaches that they’re able to do a little better.”
On the non-labor side of costs, Swanson pointed out hospitals are still grappling with continued pressures from increasing drug expenses that exceed inflation. Last month’s increased inpatient volumes and patient acuity drove some pretty substantial increases in drug and supply expenses, he said.
“The drug companies continue to hold the hospitals over the barrel with price increases that just continue and continue and continue,” Black said. “Any one month isn’t enough to make a difference. But if you add it up over the 13 months we’ve been watching this closely, there’s a shift in materiality. Drug prices—if you extend it back several years before this trend started—were fairly steady year over year for a bunch of years and the pharma companies, whatever they’re doing, they’re knowing how to become more profitable.”
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Phase 2 data of aprocitentan, Idorsia dual endothelin receptor antagonist, at ESC

  • Phase 2 dose-finding study demonstrated the blood pressure lowering effect of aprocitentan
  • A global Phase 3 study “PRECISION” in patients whose blood pressure remains uncontrolled despite receiving at least three antihypertensive medications is ongoing
  • As part of the Phase 3 program, the company is initiating an additional study “INSPIRE-CKD” for the treatment of patients with uncontrolled blood pressure and chronic kidney disease stage 3 or 4
Idorsia Ltd (IDIA.SW) today announced that the results of the Phase 2 study with aprocitentan were presented at the European Society of Cardiology (ESC) 2019 Congress in Paris, France.
Hypertension (high blood pressure) is one of the most common cardiovascular risks, and its prevalence continues to rise. According to a recent study, there are more than 1 billion people living with hypertension worldwide. Left uncontrolled, hypertension can lead to life-threatening conditions such as stroke, ischemic heart disease, or kidney disease.
Aprocitentan is an orally active dual endothelin receptor antagonist (ERA). Aprocitentan at doses of 12.5 and 25 mg is currently being investigated for the treatment of patients whose blood pressure is uncontrolled despite receiving triple antihypertensive medications (categorized as resistant hypertension) in a global Phase 3 registration study, “PRECISION”. The doses were selected based on a Phase 2 dose-finding study which evaluated the efficacy, safety and tolerability of a once-a-day oral regimen of four dose levels of aprocitentan in patients with essential hypertension. Results of this Phase 2 study were presented at ESC Congress 2019.
Phase 2 study in adults with essential hypertension presented at ESC
Parisa Danaietash, PhD from Idorsia gave an oral presentation entitled “Efficacy and safety of various doses of the new dual endothelin receptor antagonist aprocitentan in the treatment of hypertension”.
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Supplemental Oxygen Fails Once Again in Acute Coronary Syndrome

Another study testing the use of supplemental high-flow oxygen therapy in all patients with suspected or confirmed acute coronary syndrome has failed to demonstrate a reduction in the risk of death at 30 days when compared with a standard protocol that provided oxygen only if saturation levels fell below normal.
Presenting the New Zealand Oxygen in Acute Coronary Syndrome (NZOTACS) study at the European Society of Cardiology (ESC) Congress 2019, Ralph Stewart, MD (Green Lane Cardiovascular Service/Auckland City Hospital, New Zealand), reported that 30-day mortality was 3.1% in patients treated with the liberal oxygen strategy and 3.0% in those treated with the standard protocol, a nonsignificant difference.
There was a trend toward benefit in the roughly 10% of patients with low oxygen saturation levels (SpO2 < 95%), with the absolute risk of death 1.0% lower at 30 days among hypoxemic patients who received supplemental high-flow oxygen compared with those treated with the standard protocol.
“Overall, there was no real difference—not harmful but not beneficial,” said Stewart during a press conference announcing the results. “We did find that when the patients’ oxygen level in the blood falls below normal, and it’s not as much below normal as people currently think, mortality increases substantially. In those patients we can’t be so sure there was no benefit or harm. There may be a benefit.”
The key message here is that if a patient is having a suspected heart attack and the oxygen in the blood is normal, then you don’t need oxygen, although it probably won’t do any harm.RALPH STEWART“”
Supplemental oxygen has been given to patients with MI for more than 50 years and yet there has never been a clinical trial showing that it improves outcomes, said Stewart. In fact, the AVOID trial raised the possibility that supplemental oxygen might cause myocardial injury when given to acute MI patients without hypoxemia. The DETO2X-AMI study, presented 2 years ago at this same meeting, showed supplemental oxygen wasn’t harmful, but also that its routine use did not lower the risk of death at 1 year in patients with suspected acute MI with hypoxemia.
More recently, a meta-analysis combining eight randomized trials of various sizes, of which DETO2X-AMI was the largest with more than 6,600 patients, also showed there was no harm or benefit to supplemental oxygen therapy in patients who were not hypoxemic.
Is Further Study Needed? Maybe, Says Investigator
With NZOTACS, which was presented during a late-breaking Hot Line session today, investigators conducted a cluster, randomized, crossover trial comparing the two oxygen protocols in 40,872 patients with suspected or confirmed acute coronary syndromes in ambulances and hospitals in New Zealand. The supplemental high-flow protocol included oxygen for ischemic symptoms regardless of SpO2 levels. The standard protocol included oxygen supplementation only if SpO2 levels dropped below 90% (the goal was to reach a target SpO2 of 94% or greater).
Given the trial design, Stewart said they also captured patients without ACS. When they restricted their analysis to patients with STEMI, 30-day mortality was 8.8% in patients treated with liberal high-flow oxygen therapy and 10.6% in patients treated with the standard protocol (OR 0.81; 95% CI 0.66-1.00). Nevertheless, Stewart said the STEMI subgroup analysis should be viewed as hypothesis-generating only and needs to be confirmed in a larger study.
Most patients studied in the trial had normal SpO2 levels, but for those with hypoxemia, mortality at 30 days was more than fourfold higher than in patients with normal oxygen saturation. For the 3,273 patients with SpO2 levels less than 95% on ambulance arrival, 30-day mortality was 10.1% for patients who received supplemental oxygen and 11.1% for those who only received oxygen if SpO2 levels dropped below 90%.
“The key message here is that if a patient is having a suspected heart attack and the oxygen in the blood is normal, then you don’t need oxygen, although it probably won’t do any harm,” said Stewart. “If the oxygen level is below normal, it might be beneficial, but we need another big study to know that for sure.”
Steen Dalby Kristensen, MD, DMSc (Cardiovascular Research Centre, Aarhus University, Skejby, Denmark), who was not involved in the trial, said that in the past there wasn’t much physicians could do for patients with MI. “One of the things we could do was to give them oxygen,” he told TCTMD. “Now I think we know that if the patient doesn’t have low oxygen levels, then it doesn’t work. This is what I think we’ve learned.”
At his hospital, supplemental oxygen is given only to patients with low levels, meaning SpO2 less than 94%. The 2017 ESC guidelines for the management of STEMI patients only recommend oxygen in hypoxemic patients. Routine oxygen is not recommended in patients with SpO2 levels (percentage of oxygen saturated with hemoglobin) 90% or higher. Kristensen noted that individuals with low oxygen levels tend to be in heart failure, and this poor pump function can lead to lung congestion and low arterial oxygen saturation.
In the 2017 DETO2X-AMI study, investigators only randomized patients into the trial once consent was given, an approach that tended to exclude sicker MI patients. Oxygen administration was more prolonged in the DETO2X-AMI , whereas the NZOTACS investigators provided oxygen only as long as myocardial ischemia was present. Despite these differences in trial design, Stewart said their study lines up with the absence of benefit observed in the DETO2X-AMI study.
For Robin Hofmann, MD, PhD (Karolinska Institute, Stockholm, Sweden), the principal investigator of DETO2X-AMI and scheduled discussant during the ESC session, the NZOTACS trial strengthens the evidence against the routine use of oxygen in patients with acute MI with ST-segment elevation. Regarding the subgroup analyses suggesting potential benefit in those with low oxygen levels, or in the STEMI subgroup, he said such findings need to be validated in future studies.
Sources
  • Stewart R, Jones P, Dicker B, et al. The New Zealand Oxygen in Acute Coronary Syndromes trial. Presented at: ESC 2019. September 1, 2019. Paris, France.
Disclosures
  • The NZOTACS was funded by the National Heart Foundation of New Zealand.
  • Stewart, Kristensen, and Hofmann report no relevant conflicts of interest.
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PhaseBio Announces Presentation of PB2452 Data at ESC Congress 2019

PhaseBio Pharmaceuticals, Inc. (PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, today announced that pharmacodynamic data from the Phase 1 clinical trial of PB2452, a novel reversal agent for the antiplatelet drug ticagrelor, have been selected for oral presentation at ESC Congress 2019, being held August 31 – September 4, 2019, at the Expo Porte de Versailles in Paris, France.
Presentation details are as follows:
Title: Evaluation of the Pharmacodynamics of a Ticagrelor Reversal Agent PB2452
Session: New Developments in Anti-Thrombotic Drug Therapy
Date / Time: Sunday, September 1, 17:32 – 17:50 GMT/ 11:32 – 11:50 AM EDT
Location: Reykjavik – Village 2
Presenter: Lisa K. Jennings, Ph.D., University of Tennessee Health Science Center
Additional information can be found on the ESC Congress website here.
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Blocking specific protein may yield new treatment for deadly prostate cancer

Blocking a kinase known as CDK7 sets off a chain reaction that results in the death of prostate cancer cells that have spread and are resistant to standard therapies, according to a new study from researchers in the Abramson Cancer Center at the University of Pennsylvania. The team identified the role of CDK7 as the on/off switch that controls Med-1, a process that works in partnership with the androgen receptor to drive prostate cancer growth. Researchers show turning the switch off eventually leads to the death of cancer cells in mice. Cancer Discovery published the findings today.
Androgen deprivation therapy is a standard approach to treating prostate cancer, but over the course of treatment, a majority of patients will eventually become resistant to the therapy, allowing the cancer to grow and spread. This is referred to as metastatic castration-resistant prostate cancer (CRPC). There are two drugs approved by the U.S. Food and Drug Administration for these cases, but patients see little or no long-term survival benefit from these therapies.
Since the androgen receptor (AR) continues to be the main the driver of cancer growth in CRPC, taking away its function is still critical. Given the disease’s resistance to therapies that try to take on AR directly, a new approach is needed. While these cancers do not have additional mutations or other genetic overexpression, the Penn team was still able to identify a new target thanks to what researchers called “AR’s co-pilot.”
“We know that AR does not work alone; that it needs Med-1 as its partner,” said the study’s senior author Irfan A. Asangani, PhD, an assistant professor of Cancer Biology in the Perelman School of Medicine at the University of Pennsylvania. “Our study found a way to turn off Med-1, leaving AR without its co-pilot which means the cancer cannot grow and the cells eventually die.”
Using an inhibitor to turn off CDK7 led to the death of CRPC cells in both the lab setting and in animal models. Researchers also saw very limited off-target effects of this approach, since healthy cells have redundancies in place to deal with the loss of Med-1, meaning only the cancer cells end up dying off.
“Our theory is that these cancer cells are addicted to Med-1 and AR but other cells are not, so we’re essentially cutting them off from their addiction,” Asangani said.
CDK7 inhibitors are already being tested in phase I clinical trials for other cancers — including leukemia, lung cancer, glioblastoma, and breast cancer — but Asangani said this study shows the rationale for testing them in CRPC.
Reyaz ur Rasool, Ramakrishnan Natesan, and Qu Deng are co-first authors on the study. Other Penn authors include Shweta Aras, Priti Lal, Samuel Sander Effron, Erick Mitchell-Velasquez, Jessica M. Posimo, Lauren E. Schwartz, Daniel J. Lee, and Donita C. Brady.
Story Source:
Materials provided by University of Pennsylvania School of Medicine. Note: Content may be edited for style and length.
Journal Reference:
  1. Reyaz Ur Rasool, Ramakrishnan Natesan, Qu Deng, Shweta Aras, Priti Lal, Samuel Sander Effron, Erick Mitchell-Velasquez, Jessica M Posimo, Shannon Carskadon, Sylvan C Baca, Mark M Pomerantz, Javed Siddiqui, Lauren E Schwartz, Daniel J Lee, Nallasivam Palanisamy, Goutham Narla, Robert B Den, Matthew L Freedman, Donita C. Brady, Irfan A Asangani. CDK7 inhibition suppresses Castration-Resistant Prostate Cancer through MED1 inactivation. Cancer Discovery, 2019; CD-19-0189 DOI: 10.1158/2159-8290.CD-19-0189
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Anabolic-androgenic steroid use tied to decreased heart function in weightlifters

Illicit performance-enhancing steroids can cause the heart to thicken and reduce its ability to function, according to research presented today at ESC Congress 2019 together with the World Congress of Cardiology.(1)
Use of anabolic-androgenic steroids (AAS) has long been feared to have hazardous cardiovascular effects, but only recently has this been demonstrated in studies.
The study presented today examined the effects of long-term AAS use on left ventricular systolic function by assessing the size, thickness, mass and function of the heart in male weightlifters.
“Our study found that illicit steroid use is associated with a number of worrying effects on the heart. We demonstrated that AAS-using weightlifters have a thicker heart muscle and reduced ability to contract the ventricular chambers of the heart during a cardiac cycle,” said Rang Abdullah, a third-year medical student at the University of Oslo, Norway.
“Having a heart that doesn’t contract the way it should is associated with higher mortality,” he added.
The study is part of a large multidisciplinary study on AAS use, which includes studies on brain imaging, cognitive, psychological, and other cardiovascular functions.
Study authors recruited 100 male weightlifters – 58 with more than a year of cumulative AAS use and 42 who do not use steroids – with no difference in age or BMI between the two groups.
The size, thickness, mass and function of the heart were measured with echocardiography, which uses sound waves to monitor heart and valve function, and ejection fraction, which measures how much blood the left ventricle pumps out with each contraction.
AAS-using weightlifters had a thicker heart muscle – on average, a 2 mm thicker interventricular septum, which is the wall separating the lower chambers of the heart. The left ventricular posterior wall was also, on average, 1.2 mm thicker in the steroid group.
The steroid group also showed reduced ability to contract the ventricular chambers of the heart during a cardiac cycle. Both ejection fraction and ventricular global strain, a new method to assess systolic function, were decreased in AAS-exposed weightlifters as compared to the non-steroid group, 49% vs. 53%, on average, and -15.6% vs. -18.3%.
Abdullah said, surprisingly, only a minority of steroid users in the sample had experienced cardiovascular symptoms related to their AAS use.
“Continuous, long-term use of AAS might prove to be a ‘silent killer’ but it is too early to tell,” he said.
“There are many case-studies out there on AAS-using weightlifters who end up dead or hospitalised from a heart attack or life-threatening cardiac arrhythmias. This is why prospective observational trials on this subject are so desperately needed,” he concluded.
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Authors: ESC Press Office
Mobile: +33 (0) 7 8531 2036
The hashtag for ESC Congress 2019 together with the World Congress of Cardiology is #ESCCongress
Funding: The Anabolic Androgenic Steroid Research Group study is funded by a grant from the South-Eastern Norway Regional Health Authority to project leader Astrid Bjørnebekk and through the research programme at the University of Oslo (Forskerlinjen).
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