Issue 114

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 happening this week in the world of pharma digital products and FDA-regulated digital health:

• The FDA granted Swing Therapeutics Breakthrough Device Designation for its digital therapeutic for the management of fibromyalgia. Swing also announced plans to kick off a real-world study and that its $9 million seed round was led by JAZZ Venture Partners. Swing also posted details about a clinical trial (busy week): “This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of three digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.” It seems to be comparing two prescription digital therapeutics that both use Acceptance and Commitment Therapy (ACT).
• Last week it was the PTs, this week the American Psychological Association (APA) outfitted its members with a template to submit comments about next year’s Physician Fee Schedule. Most of the letters include this paragraph in support of RTM: “CMS should adopt codes 989×1-989×5 for remote therapeutic monitoring (RTM). Psychologists are among the health care professionals who provide non-physiologic services through RTM and must be allowed to bill Medicare under these codes. Reimbursement under the new RTM codes should be the same as for the remote physiological monitoring (RPM) codes that the RTM series was designed to resemble.”
• Pear Therapeutics announced that UnitedHealth’s PBM OptumRx now includes Pear’s three commercially available, prescription digital therapeutics: “OptumRx will offer and administer standard pharmacy benefit coverage for reSET, reSET-O and Somryst for members who choose to add the products to their formularies.” I’m not sure this is new. Back in May (Issue 103) when I wrote about the various formularies I found Akili’s EndeavorRx featured in, one was an employer customer of OptumRx. While that employer’s OptumRx-managed formulary included EndeavorRx, it also included Pear’s three PDTs.
• Gurnet Point Capital co-led Mahana Therapeutics whopping $61 million Series B with JAZZ Venture Partners. While JAZZ has backed many digital therapeutics companies, the only other digital health investment from Gurnet was Crossover Health way back in 2016. It typically focuses on biopharma startups.
• Wise Therapeutics revealed results from a study it did with NYU Langone focused on its prescription digital therapeutic, Personal Zen. The study aimed to show the company’s “gamified therapies can serve as an at-home, non-pharmaceutical treatment for anxiety in multiple sclerosis (MS) populations.” Wise also indicates in that announcement its intention to launch under the current FDA waiver for psychiatric-focused digital devices during the pandemic: “Our intention is to market our next generation of products as Prescription Digital Therapeutics (PDTs) for targeted populations like MS, taking advantage of new regulatory and reimbursement pathways that have emerged to help meet the heightened need for accessible mental health treatments.”
• One more thing… Only one clinical trial update of note, so I’ll mention it here. Back in February (Issue 087), I wrote about this Celgene-AmalgamRx study: “Amalgam Rx and Celgene are just beginning a multi-center, randomized, pilot trial to evaluate the MyHOPE for multiple myeloma (MM) Platform. The pilot trial will study how having real-time data streaming to a healthcare provider’s portal changes the outcomes for patients using the platform. One cohort will have real-time data sharing, while the other will only share data (if they choose to) during visits with their provider. Researchers aim to collect engagement metrics and usability ratings.” This week the companies announced their decision to terminate the study: “Study faced multiple challenges and its launch was heavily impacted by COVID, which in turn has significantly impacted the deployment and adoption goals for a digital technology pilot. These factors led to the difficult decision to close the study.”

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Pipeline changes: Akili, Better Therapeutics, Limbix, Swing Therapeutics, Blue Note and more

I spent some time this week updating the E&O PDT Pipeline Tracker, which was missing a few recently announced therapeutics. I also went looking for quiet changes to other prescription digital therapeutics companies’ pipelines and made some changes as a result. (Am I missing any that you are tracking or working on at your company? Let me know and I’ll add them in!) Here are a few highlights:

Swing comes out of stealth with Tempo PDT for fibromyalgia

This week Swing Therapeutics released details about its first PDT, which I believe is called Tempo, for the management of fibromyalgia.

Akili streamlined its pipeline around the time of the EndeavorRx launch

A reader asked me about a since-removed listing in E&O’s PDT database for Akili. In its original iteration, I had listed an early-stage product from Akili focused on chronic pain, which appeared in Akili’s pipeline tables a few years ago. These days, Akili’s public-facing pipeline is even more streamlined. It lists just a handful of PDTs on the commercial path, including:

• Pediatric ADHD (ages 8-12),
• Pediatric ADHD (ages 13-17), and
• Adult ADHD.

The company also lists candidates for MDD, MS, autism spectrum disorder, and COVID-related brain fog but not much else. So, I removed the listings for Akili’s candidates focused on lupus, traumatic brain injury, and ICU delirium since the company is not showing them on their most recent pipeline diagram.

Limbix’s first PDT Limbix Spark for adolescent depression

I added Limbix’s first prescription digital therapeutic (LX001) Limbix Spark. The clinical trial for this PDT is here and a description of the intervention reads:

Click Therapeutics PDT with Boehringer Ingelheim

Another prescription digital therapeutic that was in the E&O database but should have been was the most recent one from Click — its schizophrenia-focused DTx, which is developing in partnership with BI. (I also noticed that Click’s PDT for migraines has progressed into the proof of concept stage.)

Better Therapeutics adds Type II diabetes with hypertension PDT

Around the time of its SPAC merger, Better Therapeutics added one PDT to its lineup and shifted a few of its old codenames around as a result. So apart from its flagship PDT focused on Type II diabetes, Better has these four in its lineup:

• BT002 is now Type II with hypertension
• BT003 is now Hypertension
• BT004 4 is now Hyperlipidemia
• BT005 is now Hypertriglyceridemia

Blue Note Therapeutics reorganizes pipeline by stage of cancer

Here’s an interesting change over at Blue Note. Now the company shows four prescription digital therapeutics in its pipeline, but they no longer list a therapeutic area for each. Instead, the four PDTs are targeting different stages of cancer. Assumedly, they all focus on treating anxiety and depressive symptoms. Blue Note’s clinical trial for BNT001 describes it as “a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant’s mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients” that treats anxiety and depressive symptoms.

Interestingly, on Blue Note’s current company pipeline the company now describes BNT001 as for people with early to mid-stage cancer progression. BNT201 is described as for acute in-patient care and is at the proof of concept phase, while BNT301 and BNT401 are both in development and focus on late-stage and survivorship, respectively.

Cognoa’s CanvasDx is cleared and its CanvasTx is in POC

Of course, Cognoa’s CanvasDx now has FDA market authorization (Issue 104) and its autism spectrum disorder therapeutic has moved up into the proof-of-concept phase.

Happify took the wrappers off its first PDT Ensemble

In July (Issue 111), Happify revealed details of Ensemble, a prescription-only digital therapeutic for people with generalized anxiety disorder (GAD) or major depressive disorder (MDD).

Woebot rearranged its pipeline a little

Woebot moved its former WB004 to the WB002 spot — this DTx focuses on moderate depression in adolescents. Woebot’s WB003 focused on adult depression is no longer listed on its website and its old WB002, which focused on substance use disorder, no longer has a candidate number. Woebot does currently list a third focus area on alcohol use disorder and its derivatives.

Hit reply and let me know if I’m missing any other prescription digital therapeutics in the E&O Pipeline tracker, and I’ll get them added right away.

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