• Vicore Pharma and Alex Therapeutics partnered due to complementary competencies, with Alex Therapeutics specialising in product development based on patient-centric design and evidence-based psychology
• Anxiety was identified as a key unmet need for pulmonary fibrosis patients, and validated through patient, clinician and key opinion leader interviews
• A custom, digital CBT and ACT-based program was developed through co-creation and an iterative design process
• In the pivotal randomized controlled trial a statistically significant 2.7-point improvement in GAD-7 anxiety score was found for patients on Almee, compared to control

Key insights

Our experience in developing this digital companion for patients with anxiety in partnership with Vicore Pharma offers some important insights for companies who are interested in developing similar products:

1. Building a digital product provides a great opportunity to build relationships and improve brand recognition amongst healthcare professionals in preparation for a drug launch
2. Ensuring patient community alignment and garnering product support necessitate involving patient advocacy groups and end-users at the early stages of the development process
3. Product design that is grounded in patient unmet needs and developing prototypes alongside patients and healthcare professionals is essential to ensure that the solution provides significant value immediately at launch
4. Engaging with regulatory advisors early in the product development process is important to ensure the solution is compliant with geography-specific regulations, and can have an efficient route to market once ready for commercialization
5. Robust clinical trial evidence validates the benefit of the product and opens up commercial opportunities

Background

Vicore Pharma is an innovative clinical-stage pharmaceutical company dedicated to creating life-changing treatments in diseases where the AT2 (angiotensin II type 2) receptor has a central role in stopping and reversing disease pathology.

Embedded in the Vicore Pharma approach is the determination to find holistic solutions for patients and their families. As part of that approach, Vicore Pharma was interested in developing a digital therapy to support Pulmonary Fibrosis (PF) patients. 

Vicore Pharma decided to partner with Alex Therapeutics due to its expertise in patient-centric design and evidence-based psychology, as well as its proven modular technology platform, putting the company in a unique position to develop, launch and test a regulated digital health product to support PF patients.

Identifying patients’ unmet needs

Anxiety is  a common symptom for patients with IPF, with up to 63% of patients shown to have treatable levels of anxiety, defined as a score of ≥5 on the GAD-7 scale (Shull & Walmar, poster presentation, Respiratory Effectiveness Group Summit, March 2022). The hypothesis was that anxiety management was one of the core clinical needs that could be addressed comprehensively and uniquely via a digital health product. 

To validate the hypothesis and better understand the needs of PF patients, Alex Therapeutics undertook a comprehensive literature review and then interviewed over 70 patients to gain first-hand insight into their disease and treatment needs.

In addition, medical professionals were interviewed to understand the clinician's perspective on where a digital product would fit into the clinical care pathway, and how it could potentially provide valuable clinical support data for them.

Further real-world insights were gathered from interviews with nurses and other key experts and opinion leaders in ILD (or pulmonary fibrosis). Based on this research and interviews, the clinical priorities and needs were determined, with treating psychological symptoms such as anxiety confirmed as one of most important needs that could be addressed through a mobile app.

Designing and developing the product

The research undertaken to understand how patients with pulmonary fibrosis manage their disease and treatment was used to help inform the intended use for the product and its scope. Based on this, our team could narrow down which of the Alex Therapeutics platform modules would be most appropriate to customize within the product scope.

The Alex Therapeutics product team are experts in user experience design, and during the development phase undertook walk-throughs of the user experience with patients to ensure that all the key features were being built to meet their needs. In this phase, patient journeys are also used to illustrate how a patient would progress through the application and engage with particular treatment programs.

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Cognitive behavioral therapy (CBT) is a well-established method to treat anxiety, a common psychological comorbidity with pulmonary fibrosis, and digital CBT has the advantage of being accessible from home and around-the-clock, and can also be personalized to meet individual needs. 

Alex Therapeutics developed a 9-week program based on CBT and ACT (Acceptance and Commitment Therapy) as an addition to other treatment options for PF patients. The psychological treatment part of the program included tools and modules related to components of CBT and ACT protocols such as functional behavior analysis, acceptance, mindfulness, exposure, valued action, and sustainable change, delivered through interactive text, images, animation, and videos.

In addition, the application provided:

• Engaging and personalized tools and sound exercises
• Tools for tracking progress, complete with encouraging reminders and notifications

Once the core components of the product were finished, an iterative process was undertaken with patients providing feedback and testing functionality in preparation for the pilot study. The feedback was overwhelmingly positive.

“I’m really liking how mindful you are of people’s feelings and thoughts, and what that looks like putting it into an app; sometimes it’s really hard to convey…what it's really like to be somebody who has a lung disease….The amount of work and the way it’s shaped is really amazing.” 

Ensuring regulatory compliance and valid clinical data collection

In parallel to the product design process, a regulatory analysis was undertaken by the Alex Therapeutics regulatory team, to determine the potential medical device risk classification for the product and the optimal regulatory pathway via the FDA. It’s important to build any digital product with the end commercialization pathway in mind, and as part of that process a thorough regulatory analysis should be completed.

At the same time, a clinical trial protocol was developed by Vicore Pharma to map out how a pilot and then subsequent larger pivotal study could be undertaken with robust clinical methodology and validated psychometric measures. The aim was to assess levels of clinical anxiety and quality of life at the start and end of the intervention, as well as the acceptability of the application.

Pilot testing Almee™

At the end of the product development process, Alex and Vicore Pharma could unveil Almee^TM, a novel digital therapy for patients with pulmonary fibrosis that includes a treatment program aiming to reduce anxiety. 

Almee was clinically tested via the COMPANION study, which consisted of two phases; a pilot study designed to refine the interactive nature of the therapy session, followed by a pivotal study. 

The Pilot study was a 4-week, single-arm, decentralized, open-label clinical investigation in 10 patients with self-reported anxiety related to IPF. The primary objective of the study was to test the functionality, user experience, and safety of the product, which were all found to be positive.

Additionally, the pilot study provided encouraging early indications of efficacy. The patient-reported Generalized Anxiety Disorder (GAD-7) results showed clinically meaningful reductions.  A reduction in the GAD-7 score of  ≥1.8 points is regarded as clinically meaningful. The GAD-7 scale is widely used in clinical practice as an assessment tool for anxiety; scoring ranges from 0 to 21 with four levels spanning minimal anxiety (0 to 4) to severe (15 to 21). These results, together with the safety, functionality, and user experience indicators suggested that the product could serve as a reliable resource for addressing the psychological impact of living with IPF.

Clinical validation via a randomized controlled trial

Following the positive Pilot study, a robust pivotal study was initiated. The study assessed the effectiveness and safety of Almee™ on the psychological symptom burden of PF via a US-based 9-week, randomized, controlled, parallel-group decentralized clinical investigation - with the primary endpoint being the change from baseline in GAD-7 anxiety scores.

The study enrolled 108 participants from across the United States. The study met its primary endpoint, with a statistically significant 2.7-point improvement in GAD-7 anxiety score compared to control. Quality of life, measured by the K-BILD, was a key secondary endpoint and improved by 4.4 points compared to control, and the K-BILD psychological domain improved by 6.5 points.

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To discuss partnership opportunities, please contact us at: partner@alextherapeutics.com