Stockholm, March 19, 2024 – Alex Therapeutics and Vicore Pharma today announced FDA Breakthrough Device Designation status for Almee™, a 9-week digital cognitive behavioral therapy (CBT), to be used as an adjunct treatment of anxiety symptoms related to PF.

• Almee™, developed by Alex Therapeutics in partnership with Vicore Pharma, is an app that offers personalized treatment for anxiety based on cognitive behavioral therapy (CBT)
• Almee has shown effectiveness in reducing anxiety symptoms and improving health-related quality of life in the COMPANION study as reported earlier this year, driving a 2.7-point increase in GAD-7 score and a 4.4 improvement in KBILD score.

The FDA Breakthrough Devices Program designates those medical devices that are evaluated as providing a more effective treatment for life-threatening or irreversibly debilitating diseases. Breakthrough designation reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis and highlights the significant impact of this digital therapy.

Almee™ is a patient-facing tool, accessed via a smartphone or tablet, that offers personalized treatment for anxiety based on cognitive behavioral therapy (CBT). The COMPANION study on Almee demonstrated a 2.7-point improvement over control in GAD-7 (generalized anxiety disorder scale) and a 4.4 improvement in KBILD (King’s Brief Interstitial Lung Disease) total score for quality of life.

PF affects approximately 250,000 people in the United States[1], with increasing incidence[2]. Currently available therapies only slow the progression of this devastating and fatal disease. The physical burden of PF drives psychological impact with studies showing that 60% of patients with PF report having anxiety[3].

"Receiving the FDA's Breakthrough Device designation underscores the uniqueness of our product and its significant impact for PF patients. We're thrilled to leverage our technology to continue addressing comorbid mental health distress, reaffirming our commitment to pioneering solutions that enhance well-being,” said Maria Rickardsson, Chief Quality and Regulatory Officer at Alex Therapeutics.

Vicore is seeking to advance Almee™ in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis.

“Almee represents the future of healthcare and is poised to deliver significant patient impact as an example of innovation in digital-molecular combination therapies,” said Jessica Shull, PhD, Director of Digital Health at Vicore.

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For further information, please contact:

Paul Kirchmeier, Chief Operating Officer

+46 (0)73 095 8633, paul.kirchmeier@alextherapeutics.com

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About Alex Therapeutics

Alex Therapeutics, a digital health company, partners with pharmaceutical companies to help patients with disease and treatment-specific challenges through clinically validated apps. With its proven, scalable technology platform, as well as expertise in patient-centric design and evidence-based behavior change, Alex Therapeutics treats patients and supports healthcare professionals globally. Alex Therapeutics, alongside its partners, has extensive experience in multi-jurisdiction Software-as-a-Medical-Device (SaMD) regulatory processes, including CE and FDA approval, as well as clinical evidence generation for SaMDs. Follow us on LinkedIn for further updates.

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About Vicore Pharma Holding AB (publ)

Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

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[1] www.pulmonaryfibrosis.org/understanding-pff/about-pulmonary-fibrosis/what-is-pulmonary-fibrosis

[2] Pergolizzi JV Jr, LeQuang JA, Varrassi M, Breve F, Magnusson P, Varrassi G. What Do We Need to Know About Rising Rates of Idiopathic Pulmonary Fibrosis? A Narrative Review and Update. Adv Ther. 2023 Apr;40(4):1334-1346. doi: 10.1007/s12325-022-02395-9. Epub 2023 Jan 24. PMID: 36692679; PMCID: PMC9872080.

[3] van Manen MJ, Kreuter M, van den Blink B, Oltmanns U, Palmowski K, Brunnemer E, et al. What patients with pulmonary fibrosis and their partners think: a live, educative survey in the Netherlands and Germany. ERJ Open Res. 2017;3:00065–2016

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