Issue 116
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 things happening in the world of pharma digital products and FDA-regulated digital health:
- This week I added Vicore Pharma’s prescription digital therapeutic for IPF to the E&O PDT Pipelines Tracker. Vicore is working with Alex Therapeutics to develop the DTx, which “will provide treatment for currently undertreated symptoms associated with IPF such as depression and anxiety.” Let me know if there are any other prescription digital therapeutics that should be added. As it happens, this week Vicore’s CEO Carl-Johan Dalsgaard posted some comments about the pharma company’s strategy around VP04: “Vicore has a 360-degree strategy for addressing serious rare lung diseases. In May, in a collaborative program with Alex Therapeutics, we launched the development of VP04, a proprietary prescription digital therapeutic for patients with idiopathic pulmonary fibrosis (IPF). VP04 will be one element in a suite of treatments for IPF, sitting alongside our development programs for drug therapies such as VP01(C21) and our inhaled thalidomide product for IPF and IPF cough, VP02. VP04 is designed to support patients in dealing with the psychological burden of IPF and improve quality of life. It is being developed to be prescribed to relevant patients and therefore will need regulatory approval based on clinical evidence of effectiveness. It will also help increase awareness and understanding of IPF amongst healthcare professionals including physicians and payers.”
- I mentioned that Akili updated its video game therapeutic EndeavorRx with new gameplay a few weeks back (Issue 111). Now, the company is touting the update in its marketing to prospective patients and their caregivers: “A brand new set of adventures has come to EndeavorRx! We’re excited to announce a fresh set of features requested by kids + caregivers that will totally evolve our gameplay while maintaining our FDA-approved treatment tech for ADHD. – Brand new quests – More player choices – Personalize your universe – Unlock new creatures + costumes – Improved optionality for every patient.”
- AppliedVR inked a one-year deal with decentralized clinical trial company Curebase “to run five clinical trials assessing the effectiveness of virtual reality-based (VR) therapy to treat chronic pain.”
- One more thing… Better Therapeutics, which is in the process of going public via a SPAC, said it secured a loan facility for up to $50 million from Hercules Capital.
Did a friend forward this to you? You, too, can win friends and influence people via newsletter forwards by clicking right here. Become the newsletter-forwarder we both know you were meant to be. Act fast! This offer won’t last forever (I am not immortal).
Trial updates: Apple-Janssen, Proteus, Happify, Amgen and more
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.
Janssen and Apple’s big Heartline study doesn’t study completion until 2025 now
Small update: Janssen and Apple updated their Heartline study timeline. Prior to this week, the study completion target date was December 31, 2024, but the companies just pushed it back until March 31, 2025. The companies expect to enroll about 150,000 people.
“The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.”
Signs of life in two Proteus Digital Health’s clinical trials
Surprised to see updates to two clinical trials that use Proteus Digital Health’s technology. The first: “Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy,” which is a collab between UC San Diego, Gilead, GSK and others that got its start in June 2016, is now active but no longer recruiting. It didn’t finish up in June 2021 as expected but is now set to finish in December.
“This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their ARV medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their ARV medications.”
The second: “Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)” got it start more recently in October 2018. This one is also a collab with Gilead and UC San Diego. Like the trial above this one is also set to finish up in December 2021 now.
“This study is a prospective single arm open label intervention study over 12 weeks using the [digital health feedback system] with participants initiating or continuing HIV PrEP. The study intervention has an initiation (Phase 1), persistence (Phase 2) and follow-up period up to 96 weeks. In phase 1 participants will use the DHFS with close follow-up incorporating visits with directly observed ingestions. In Phase 2 the participants utilize the DHFS in their natural setting with sporadic study visits until 12 weeks.”
Details on Happify’s digital therapeutic for MDD and GAD
There may not be any surprises here, but Happify posted all the details on its clinical trial for its forthcoming prescription digital therapeutic for major depressive disorder and generalized anxiety disorder, Ensemble:
“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. Participants are then followed for a period of 12 months.”
Amgen’s wearable-powered heart failure study recruits 18 instead of 120
Amgen’s study on heart failure therapy decisions, which makes use of a wrist worn wearable from Biobeat, only managed to recruit 18 participants instead of the anticipated 120:
“A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.”
“Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator’s standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.”
Better outcomes explanations on Swing Therapeutics’ SMART-FM clinical trial listing
Small update: If you are tracking Swing’s fibromyalgia PDT closely, the company just updated its clinical trial posting with better descriptions of the various outcome measures it is using.
WW (Weight Watchers) is developing a postpartum weight loss program called ClockWork
(This is neither FDA no pharma-related, but it caught my eye while scrolling through clinical trials so I’ll include it here…)
WW is recruiting 50 participants for a new weight loss intervention for “women with prepregnancy obesity” during the first four months postpartum. The program is currently named ClockWork. WW will pit the ClockWork intervention group up against a control group that receives an email newsletter about maternal health.
“ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the CTS, weight, and health and their Amount, Regularity & Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review their digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women’s needs postpartum. Coaches will use women’s baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions.”
Links to E&O’s reports, databases, newsletters
The Exits & Outcomes site is designed to make it easy to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:
- Read through the long-form E&O research reports here.
- Search and sort the E&O databases here.
- Skim more than 150 past issues of E&O newsletters here.
