Issue 145
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’s what’s going on in FDA-regulated and pharma-focused digital health:
- The news your know: The FDA granted Google-owned Fitbit a 510(k) for an Irregular Heart Rhythm notification feature similar to the one Apple received a De Novo clearance for back in 2018. So similar, in fact, that Apple’s clearance is the predicate for Fitbit’s. One interesting difference is that Fitbit’s software is cleared for use on compatible devices fitting this description: “Consumer wrist-worn products with PPG sensors (e.g., smartwatch or fitness tracker) that have been qualified for use with Fitbit Irregular Heart Rhythm Notifications — Fitbit Sense, Fitbit Versa, Fitbit Versa Lite, Fitbit Inspire 2, Fitbit Charge 4” while Apple’s was cleared for compatible devices matching this description: “Apple Watch with PPG sensors (series 1 and later).” Interesting that the agency actually qualified the devices in Fitbit’s case while Apple’s is open-ended.
- Prescription digital therapeutics company Click Therapeutics secured a $15 million term loan from Silicon Valley Bank that, in part, will retire Click’s existing term loan facility with K2 HealthVentures (K2HV).
- The FDA granted Pear Therapeutics a Safer Technologies Program (STeP) for Medical Devices designation for Pear-010, a VR-powered prescription digital therapeutic still in development stages for the treatment of acute and chronic pain. “Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. The product candidate is designed to reduce acute postoperative and postprocedural pain and analgesic (e.g., opioid) use related postoperative urinary retention, postoperative ileus, or postoperative unintended advancing sedation and respiratory depression.” Pear also lobbied the Pennsylvania state legislature to make it easier to pay for prescription digital therapeutics for substance use disorders. Read the company’s letter to the state lawmakers here.
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).
Pfizer could use ResApp acquisition to power a COVID virtual care clinic
This week Australia-based ResApp announced that Pfizer had made a $74 million proposal to acquire the company, which comes just weeks after ResApp announced positive trial results for its cough analyzing algorithm that screens for COVID:
“ResApp Health… announced positive results for a new novel cough audio-based COVID-19 screening test that only requires a smartphone. In a pilot clinical trial of 741 patients (446 COVID-19 positive) recruited in the United States and India, ResApp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, was found to correctly detect COVID-19 in 92% of people with the infection.”
Pfizer also inked a COVID-related R&D deal with ResApp, which includes a few key parts:
- Non-exclusive research and development license in the field of COVID-19.
- 6-month term, though parties may agree to two extensions of 3 months each.
- Each party will retain all rights to its respective intellectual property and know how during the term.
- Total A$3 million ($2.2 million) up-front license fee, and up to A$1 million ($740,000) in milestone payments based on clinical trial recruitment.
- Right of First Negotiation for certain commercial transactions with third parties (including commercialization licenses) in the COVID-19 field.
The companies hope to finalize the acquisition by the end of June. ResApp’s SaMDs are already used by telemedicine providers in Indonesia, Australia, and some countries in Europe. Its other products focus on acute respiratory diagnosis, sleep apnea diagnosis, COPD monitoring, and cough counting for clinical trials. ResApp had yet to enter the US market in any major way, but it currently has at least two 510(k)s pending with the FDA for its sleep apnea and acute respiratory diagnosis SaMDs. Pfizer isn’t the first pharma company to work with ResApp. AstraZeneca tapped ResApp to use its cough counter in a clinical trial with lung cancer as well as in an asthma support program. Meanwhile, Janssen has inked a deal with ResApp to use its respiratory monitoring tech in an RSV-focused clinical trial.
What do you think? Why did Pfizer opt to buy ResApp? Should we expect a COVID virtual clinic powered by ResApp digital diagnostics and resulting in Truepill-fulfilled Paxlovid prescriptions any time soon?
Clinical trial updates: Blue Note, Oui, Babyscripts, BMS, Kaia, and Koa
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
Now recruiting: Blue Note Therapeutics’ clinical trial (RESTORE), which will compare two of its digital therapeutics for people with cancer, is now recruiting.
Now enrolling by invitation: Oui Therapeutics is enrolling participants into its trial titled: “A Randomized, Double-Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Adult Patients With Suicidal Ideation and/or Suicide Attempts.”
Now recruiting: Babyscripts is now recruiting for its study on remote monitoring of postpartum blood pressure.
Now recruiting: Pack Health, MD Anderson, and BMS are now recruiting for their study of digital health coaching for people with cancer following CAR T Therapy.
Completed but no results yet: Kaia finished up its knee and hip pain study that intended to “evaluate the effectiveness of the Kaia Knee and Hip pain app intervention in comparison to usual medical care in reducing pain and disease-related symptoms in participants with OA over 3 months.”
Pear consultant and Northwestern professor sets up RCT for digital intervention for self-injury
Dr. David Mohr, a professor at Northwestern University who has worked with Pear Therapeutics in the past, set up a new RCT for a chatbot-based digital therapeutic:
“The primary purpose of this trial is to test the feasibility of conducting a randomized controlled trial (RCT) of an 8-week digital mental health intervention (DMHI) for non-treatment engaged young adults with repeated nonsuicidal self-injury. The DMHI will be a highly interactive conversational agent that conveys psychoeducational content and guides participants through skill-based activities. We will conduct a 3-arm feasibility trial, randomizing participants to receive the self-guided DMHI, the DMHI with low-intensity coaching, or an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface.”
Koa Health pushed back two of its studies (SAD and MDD) with MGH
Koa’s study on a digital therapeutic for social anxiety disorder (SAD) is now set to start September 2023 after missing its start date last September. Similarly, Koa pushed back its major depressive disorder (MDD) DTx study from September 2021 to September 2022. Both are collabs with MGH.
SAD study description:
“The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).”
MDD study description:
“The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in SIGH-D scores than those in the waitlist condition at treatment endpoint (week 8).”
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 200 past issues of E&O newsletters here.
