Issue 154

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:

• News you know: Rune Labs secured 510(k) clearance from the FDA for its StrivePD device, which now has market authorization “to collect [Parkinson’s] patient symptom data through measurements made by Apple Watch”. What you may not know or remember is that Apple considered submitting its own Parkinson’s SaMD to the FDA years before it began the process for its 2018 ECG de novos. Stephen Friend was at Apple at the time and he led discussions with the FDA about potentially submitting a PD SaMD. Apple even invited the FDA’s Bakul Patel for an event in Cupertino that focused on its Parkinson’s efforts. Back to the present for a sentence: Rune uses Apple’s Movement Disorder API to collect data via the Watch. Maybe the FDA ultimately told Apple it didn’t need clearance for an API and that’s why it never submitted a 510(k) for a Parkinson’s SaMD as originally planned?
• At the big American Diabetes Association 2022 event this week, One Drop revealed a bit more about its forthcoming CGM device. The not-yet-FDA-cleared peel-and-stick wearable will track body temperature as well as glucose, and it will be a disposable device intended to be worn for one day. More details in the release here.
• Pharma partnership news: Eli Lilly has tapped Sidekick Health for digital support programs for people with breast cancer. “Patients will be given access to a tailored digital treatment plan that engages in health-improving tasks, which promote behavior modification and overcome barriers to change. Sidekick’s solution focuses on five main areas: physical activity, tailored diet, sleep, stress management, and medication adherence, the latter representing a significant obstacle to recovery in patients undergoing cancer treatment. Patients will also be given access to educational content that has been created in close collaboration with clinical experts and patient advocacy groups, helping to provide them with unique insights into living with cancer.” Sidekick also works with Pfizer and Bayer.
• Question for E&O readers: Why does it seem to be common to disclose upfront payments and milestone payments for some digital health-pharmaco deal announcements, while others — like the Sidekick-Lilly one above have no details? Is it because this is not a co-development deal and, therefore, Sidekick isn’t developing an asset or candidate that still has to get through regulatory milestones? Any other thoughts on the distinction between these two types of deals?
• Swing Therapeutics, a digital therapeutics company focused on autoimmune and chronic pain conditions, announced a $10.3M Series A led by JAZZ Venture Partners with a little help from Alumni Ventures, AME Cloud Ventures, Asahi Kasei Corporate Ventures, Gaingels, Kicker Ventures, Mana Ventures, and Metrodora Ventures. The company also announced its PROSPER-FM pivotal Phase 3 trial, but E&O readers have known about that one since February (Issue 138).
• Like many companies working on digital therapeutics, Otsuka submitted comments to the FDA on its draft guidance document entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials.” Otsuka’s top comment caught my eye: “Otsuka recommends the Agency clarify if this guidance is applicable to digital medicine/prescription digital therapeutics, because social determinants such as access to technology (broadband, smartphones, etc.) may be a factor that inhibits clinical trial participation.”
• One more thing… Here’s one I missed last week: “Kindbody, a leading fertility and family-building benefits provider for employers offering comprehensive virtual and in-person care, announced today the acquisition of Phosphorus Labs, a leading preventative genomics company.” Phosphorus, of course, was one of the nine companies chosen by the FDA to participate in the Pre-Cert pilot program. Having read through all of the emails that the FDA exchanged with Pre-Cert pilot participants, it sure seemed like Phosphorus barely engaged with the agency or the other participants during the pilot.

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The midnight email that marked the Pre-Cert pilot’s unraveling

On Friday, August 3rd, 2018 — 41 minutes after midnight on the east coast — Pear Therapeutics’ VP of Quality and Regulatory, David Amor, emailed the FDA’s digital health policy team on behalf of the nine companies participating in the Pre-Cert pilot program. (In case you forgot which companies were in the pilot, the FDA chose these nine: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.)

The pilot participants, or “PPs” as they called themselves in emails, were restless.

Amor’s email included an attachment, a proposal to the FDA that asked the agency to reward the PPs for their participation in Pre-Cert. The PPs drafted the proposal in July 2018 following a disappointing meeting with the FDA.

As the proposal’s “background” section lays out:

(Of course, the FDA’s estimates proved too optimistic. There have been zero pre-certifications as of June 2022. The agency would come to conclude that it could not actually execute a pre-certification program without an act of Congress granting it the authority to do so.)

The PPs hinted that this delay in pre-certifications could lead to an exodus from the pilot. Here’s what they told the FDA after its digital health policy team revealed their new timeline:

The PP’s proposal, then, was to gift streamlined reviews to the pilot participants as a way to reward them for participating in the pilot:

Ultimately, the FDA did not officially accept the PP’s August 2018 proposal. In fact, it went on to explain on its Pre-Cert FAQ page that pilot participants would not have access to a streamlined review process.

Still, the timing and wording of the PP’s proposal is curious. Apple’s de novos were well underway by the time Amor sent this email in early August. Apple would submit its final de novo submissions — after having gone through the first two modules of its customized modular de novo process — just a few days after this email from Amor hit the FDA team’s inboxes.

And remember: The FDA described the modular de novo process that it co-developed with Apple “as a test case for a more interactive and collaborative review for SaMD products.”

The PPs’ proposal included a few other specific requests that appeared to be a part of the Apple modular de novo process too. Among the “key needs” that the Streamlined Review should include from the PPs’ or Sponsors’ perspective:

And on the list of “key success factors” from the PPs’ perspective:

Apple managed to convince the FDA to customize a regulatory pathway for it in March 2018, but the wider group of nine Pilot Participants apparently failed to persuade the agency to agree to its August 2018 proposal for a customized regulatory pathway for all pilot participants.

The failed proposal marked the beginning of the end for Pre-Cert.

P.S. As E&O exclusively reported in the 2019 Pear Therapeutics report, Pear’s regulatory lead David Amor joined Apple in September 2019 to help lead its regulatory efforts with the FDA.

Clinical trial updates from Otsuka-Click, MedRhythms, Koneksa, and Roche-Novartis-Healios

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.

Otsuka and Click’s study comparing two digital therapeutics for major depressive disorder recruits 360

Otsuka and Click originally anticipated recruiting 540 participants for this one:

MedRhythms’ Parkinson’s pilot study compares its digital therapeutic to SOC

The new Amped-PD study is the second one focused on the company’s digital therapeutic for Parkinson’s. MedRhythms is also currently recruiting for its feasibility study with Johns Hopkins. More on Amped-PD:

Researchers at Northwestern, Koneksa and the Michael J. Fox Foundation working on app-based digital measurement for PD

Here’s another Parkinson’s-related study that aims to develop an app that measures disease severity via voice markers:

Now recruiting: Roche, Novartis, and Healios study to find and validate digital biomarkers for Multiple Sclerosis

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