Issue 179
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.
Here are a few recent happenings in FDA-regulated and pharma-focused digital health…
- Germany’s DiGA formulary just added its most expensive prescription digital therapeutic yet — more than twice as expensive the next most costly DiGA. GAIA’s levidex, which offers cognitive behavioral therapy to people with multiple sclerosis, is priced at €2,077.40. Previously, GAIA’s breast cancer digital therapeutic, Optimune, was the most expensive DiGA. It costs €952.00.
- German company Vivira Health’s musculoskeletal digital health program, which is listed on Germany’s countrywide reimbursed prescription digital therapeutics formulary DiGA, just lowered its price from €239.96 to €211.72.
- Pear Therapeutics announced that it had landed a contract with the state of California’s Medicaid plan to manage a two-year pilot of contingency management for stimulant use disorder patients. I dug up the details in the RFP documents, and the contract actually went into effect this past November. It runs for two years and Pear stands to generate $4 million in revenue from it, which probably makes it one of the most lucrative deals Pear has landed to date.
- Last week I mentioned that Germany (and US-based) Kaia, perhaps better known for its work in MSK these days, had secured its first spot in the German national formulary for digital therapeutics for its COPD app. I didn’t mention that Kaia partnered with pharma company Chiesi on that particular application, but a German-language press release went out in recent days to remind me.
- The news you know: Alphabet/Google-owned Verily announced lay-offs this past week, but it seems that many of the teams that E&O writes about were less impacted than other areas of the company. However, projects focused on remote patient monitoring for heart failure and microneedles for drug delivery are now shuttered. Here’s a snippet of what Verily CEO Stephen Gillett wrote in an email to employees about what’s included in one of the company’s remaining focus areas:: “Care: This refers to products and experiences designed to help people make more informed choices for their individual health and for healthcare professionals to better tailor care. This covers personalized care solutions that support patients with chronic conditions and engage patients in clinical research, and integrates elements of Onduo and Project Baseline. It also includes products and services that speed diagnosis and improve the delivery of care, such as Verily Retinal Service, an AI-based solution in development to aid in the diagnosis of diabetic retinopathy.” More here.
- One more thing… Small acquisition: “Cambridge Cognition, which develops and markets digital solutions to assess brain health, is pleased to announce its acquisition of Winterlight, a leader in monitoring cognitive impairment through free-speech analysis.” The deal included about $4.8 million in stock and $3.7 million in cash. Pear licensed some of Winterlight’s voice analysis technology back in 2020. More details and rationale for the deal here.
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Akili to lay off 46 employees and reprioritize its pipeline of prescription digital therapeutics
Akili joined Pear Therapeutics and a growing number of other later-stage digital health companies in announcing its own round of lay-offs this week. Akili said it will lay off 30 percent of its workforce or 46 people. While the lay-offs have been reported elsewhere, Akili also announced plans to dial back some of its R&D work to focus on commercializing EndeavorRx. In a letter to employees, CEO Eddie Martucci explained the move to focus the company’s resources on EndeavorRx for the near-term:
“That means a focus on EndeavorRx traction, and the key adoption, coverage, and engagement (A.C.E.) initiatives that we believe will best drive growth, and pulling back on pipeline and growth initiatives that are not necessary to drive near-term growth.”
Akili still plans to move ahead with a submission to the FDA intended to expand its label for EndeavorRx to adolescents. It also already announced that it had stopped recruiting for its adult study of EndeavorRx and was going to proceed just with the 224 patients it had already recruited. So, it seems like that will progress to the FDA submission phase too assuming the trial’s results are favorable.
Here are some new updates on the rest of the pipeline:
“For the indications with published clinical study data (Autism Spectrum Disorder (ASD), Multiple Sclerosis (MS), and Major Depressive Disorder (MDD)), the Company held the ASD FDA Q-Sub meeting in October 2022, but no longer intends to hold similar individual Q-Sub meetings for MS and MDD, in order to conserve capital and focus. Similarly, the cognitive monitoring program, which had previously been slated for initiation of a trial in 2023 or beyond, will not be directly funded in the current operating plan. However, the Company will continue investigator-initiated research in these above and related indications and programs outside of ADHD and is assessing various potential ways to efficiently progress indications and programs outside of the core operating plan, including via partnering. Finally, the two COVID Fog trials of the Company’s technology being conducted by outside academic research institutions are still slated to be analyzed in, and the Company expects to be able to share topline data in, the first half of 2023.”
Clinical trials: Twill, Pear, Woebot, Mayo Clinic, and Wise
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others that E&O mentioned in previous issues.
New: Wearables for Parkinson’s from New Touch Digital
This company is new to me. Brand new study:
“The purpose of this study is to evaluate whether New Touch Digital (NTD) NeuroRPM software installed on wearable devices can objectively measure and track symptoms in patients with Parkinson’s disease.”
Completed: Pear’s feasibility study of a new version of reSET-O
Pear ended up recruiting seven participants for this study instead of its original target: 10. No results yet:
“The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O. This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process. This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.”
Done recruiting: Woebot’s GenZ digital therapeutic for adolescent mental health
Woebot managed to recruit 141 participants — a bit shy of the 260 it hoped to recruit. More:
“The primary aim of this study is to determine the feasibility and acceptability of the W-GenZD mobile application among a group of adolescents and who have screened and triaged into low-intensity treatment within the Children’s Hospital of the King’s Daughters. The secondary aim of this study is to determine the preliminary comparative efficacy of W-GenZD and CBT-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment relative to baseline. The third aim of this study is to investigate potential differences between group differences on working alliance. An exploratory aim of this study is to observe and describe the utilization and outcomes of the safety procedures utilized within this study.”
Done recruiting: Twill is done recruiting for its study on Ensemble, a therapeutic for anxiety and depression
No official change yet, but I hear Twill has finished up recruiting for its Ensemble study. It didn’t hit the original 750 participants it estimated needing originally, but I’m not sure what the final figure was yet. More.
“This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed.”
Done recruiting: Wise Therapeutics’ study on its digital therapeutic for social anxiety disorder
No update on the final count of participants for Wise’s study, but it originally estimated 150 participants. More:
“Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.”
Completed: Mayo Clinic’s study on an allergy patch skin test with smartphone reader app
Here’s an interesting one that flew under the E&O radar (until now that it is over): Mayo Clinic managed to recruit 233 people to wear allergy skin test patches for a few days and then the researchers used an “AI-based smartphone application to record and interpret the patch test results.” Seems likely this is a study to develop an app that people can use themselves at home? More:
“Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken.”
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