Issue 115
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
Slow week. Here are just a few things happening in the world of pharma digital products and FDA-regulated digital health:
- The news you know: Google Health’s top exec David Feinberg MD left the company to join Cerner as its new CEO this week. Today Business Insider reported (sub. req.) that Google Health would no longer function as a unified entity. Its projects and teams would be redistributed across the company. It’s worth remembering that Google’s various health projects were previously distributed throughout the company at around the time Feinberg joined. He pulled them together. Google said no projects or teams would be cut as a result of this latest maneuver.
- Happify Health inked a distribution deal with higi, which operates 10,000 health kiosks stationed in retail pharmacies and grocery stores around the US.
- etectRx, which makes an ingestible event marker (similar to what Proteus Digital Health offered prior to its bankruptcy) has named one of the company’s co-founders, Eric Buffkin, as its new CEO.
- One more thing… This isn’t FDA or pharma-related but Inc Magazine announced this year’s list of the Inc 5000, which used to mean we got a look at a number of private digital health companies’ revenue numbers. Last year Inc changed it so it doesn’t reveal the actual numbers. It did, however, share a few in its great write-up of Carbon Health, which was number two on the list since it apparently grew its revenue 39,734 percent over the past three years. In its profile of Carbon Health, Inc shared that Carbon brought in more than $45 million in revenue in 2020. Revenue grew fourfold year-over-year between 2019 and 2020, Inc reported, which would mean Carbon brought in around $11 million or $12 million in 2019.
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Details on Akili’s licensing deal with TALi that will expand EndeavorRx to younger kids
This week you may have read that Akili Interactive signed a new agreement with Australia-based TALi that will expand Akili’s EndeavorRx digital therapeutic to younger children. Since TALi is publicly listed in Australia, I was able to find a few more details on the deal. As the company told me in an email this week:
“As part of the agreement, Akili will own the U.S. commercialization of TALi’s patented technology, which is proven to assess, target, and improve attention in early childhood (children ages 3-8) through a video game experience and is currently available in Australia, India, Singapore and Hong Kong. (As a reminder, EndeavorRx is indicated in children and adolescents ages 8-12.) Our next step is to work with TALi to conduct a registrational study in ADHD and then pursue U.S. regulatory approval. If successful, the technology will fit nicely into our portfolio and will enable us to help children at an even earlier age as they begin to realize the challenges of living with attention issues.”
Here are a few of the financial details I picked up from a TALi investor presentation:
- Milestone payments appear to be capped at $37.5 million: “TALi will be entitled to receive estimated total milestone payments up to AU$51 million (US$37.5 million) plus royalties.”
- Within that $37.5 million figure, Akili will pay TALi an undisclosed amount in milestone payments in 2021 related to clinical development.
- TALi expects the collaborators to secure FDA clearance in 2023, which will trigger another milestone payment of $2 million. (This is still part of the capped $37.5 million.)
- Whatever is leftover from the $37.5 million will be a function of revenue generated: “Additional milestones based on revenue scale-up e.g. US$1.5 million on $10 million sales.” That suggests that TALi will receive 15 percent of the revenue generated by the DTx until the cap is hit.
- Beyond the milestone payments: Outside of the $37.5 million, Akili will also pay TALi “high single-digit percentage royalty payments on all product sales (in addition to milestone payments).”
- Finally, the agreement has some “ongoing term provides annuity income.”
Other details in the TALi presentation:
- Duke is TALi’s partner for clinical development and trials: “Clinical development and trials collecting US-based data (facilitated by Duke Clinical Research Institute — DCRI). Existing collaboration between TALi and DCRI since June 2020. Trials to commence in 2021 with protocols for trials being finalized.”
Read the full TALi preso for investors here.
Trial updates: Apple, Verily, Click, Swing, Cereset
Here’s the weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.
More details on the Apple study in Toronto focused on heart failure: Apple posted the details of its heart failure study with the University Health Network in Toronto this week after announcing the study back in February. The five questions that Apple hopes to answer via the study caught my eye:
“Primary Research Question:
- Can biometric data obtained from the Apple Watch be used to estimate cardiorespiratory fitness, as assessed by CPET?
- Does the ‘predicted’ Apple 6 MW estimate correlate with formal 6 MWT?
Secondary Research Questions:
- Is there a relationship between novel biosensors, including oxygen saturation, and markers of poor prognosis specifically as defined by the SHFM, BNP, Quality of life (QOL) indicators, and CPET parameters?
- Can surrogates of cardiorespiratory fitness obtained from the Apple Watch, including novel biosensors, predict acute decompensation of heart failure as defined rapid clinic visits, need for IV diuretics, ED visits, heart failure hospitalization and unscheduled health care encounters during the 3-month follow-up?
- Can biometric data be used to improve a risk prediction model that can distinguish between patients at high versus low risk of all-cause hospitalization (primary outcome), all-cause mortality (secondary outcome), and a composite outcome of all-cause mortality, need for ventricular assist device, or heart transplantation (secondary composite outcome) over a 2 year period?”
Click Therapeutics completed its latest Clickotine trial: Click’s 78-participant “Exploratory, Observational, Open-label, Remote Study of Clickotine: A Digital Therapeutic” finished up in June. No results yet, but the study seemed to partially study how smokers of traditional combustible cigarettes respond to the Clickotine program vs. those who smoke traditional cigarettes as well as vape.
Details on Swing Therapeutics’ other clinical trial for fibromyalgia, Smart-FM: Last week I mentioned Swing’s React-FM real-world evidence clinical trial, which is currently recruiting, and this week the company posted details on its 500-participant Smart-FM randomized control trial, which is active but not yet recruiting:
“The objective of this study is to assess the clinical impact of a digital therapy for the management of fibromyalgia. Study participants receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia. The primary endpoint is the Patient Global Impression of Change (PGIC) at week 12. This is a virtual, single-arm, pragmatic, non-significant risk study.”
Verily’s predictors of severe COVID trial finished recruiting with 494 enrolled: Small update: Verily’s Predictors of Severe COVID-19 Outcomes (PRESCO) study stopped recruiting with 494 enrolled, which is well short of the originally anticipated 1,500 participants.
Caregiver stress relief wearable study, Cereset: Including this one as it seemed to be a novel population but Cereset is listed as an FDA-regulated wearable. Wake Forest is testing out a wearable device named Cereset with a group of caregivers (meaning family members or loved ones) who are taking care of newly diagnosed brain cancer patients:
“In this single arm, open label study, investigators will evaluate the feasibility of using the Cereset (formerly known as HIRREM – high-resolution relational, resonance-based electroencephalic mirroring) intervention for a stressed population confronting an acute burden on their lives – caregivers of newly diagnosed high-grade glioma patients. The Cereset intervention is a closed-loop acoustic stimulation intervention that has been studied in patients with PTSD, insomnia, postural orthostatic tachycardia, and military veterans.”
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