We are thrilled to share our ongoing partnership with Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a leading biopharmaceutical company committed to developing medicines to target diseases driven by dysregulated aldosterone, such as hypertension.

In the United States alone, there are over 30 million patients with hypertension who are unable to achieve their target blood pressure despite treatment. According to the World Heart Federation, hypertension is the number one risk factor for death globally that affects over 1 billion people. It is often called “the silent killer” that accounts for half of all heart disease and stroke-related deaths worldwide.

At Miracle, we are honored to partner with Mineralys and increase their efficiency to manage their clinical trials by providing an automated control tower. This collaboration marks a significant milestone as Mineralys manages its clinical trials using the Miracle platform.

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‍The Challenge – Information Isolated in Siloed Systems

With multiple global phase 2 and 3 trials underway the Mineralys team required a reliable and comprehensive solution that allowed them to closely manage their clinical and operational trial data. Miracle reduced the number of disparate tools and systems into one single access point resulting in quick decision-making and ease of visibility into areas that need attention.

For the study team, it was not adequate to simply aggregate information. In addition to communicating with senior leadership, they needed actionable insights from across all their trial platforms (i.e. EDC, RTSM, lab systems) so that the team could proactively identify potential bottlenecks and take actions to achieve data management and clinical management oversight efficiently across all their clinical trials.

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‍Enter Miracle – Actionable Insights from Transparency to Accelerate Trials

From the very start, Miracle was prepared to help Mineralys expedite their clinical trials. Within a week the Mineralys team had access to live dashboards on Miracle that emulated their manual Management Update tracker.

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The Mineralys team immediately benefited from Miracle in the following ways:

1. Automated dashboards: The Mineralys team no longer needed to spend hours maintaining and updating key trackers for their clinical trials.

2. Unified view of information: Instead of needing to log into different trial platforms (i.e. EDC, lab systems), the Mineralys team is able to obtain all the necessary information from within Miracle.

3. Communication tool: Miracle became the central hub to retrieve updates for their clinical trials so that the entire company can stay updated on the latest progress.

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In addition, Mineralys has been using Miracle to extract actionable insights to expedite their clinical trials:

1. Projecting enrollment timeline scenarios: Based on actual site performance, Miracle helps the Mineralys team project scenarios for trial timelines, as well as simulating how adding new sites or removing non-randomizing sites would impact timelines.

2. Conducting data cleaning and review in a continuous manner: In order to optimize the time between database lock and data readout, the Mineralys team is able to use Miracle to track eCRF page status, query status, and soft-lock status in a continuously ongoing manner.

3. Patient profiles and medical monitoring: Miracle enables more efficient medical monitoring with transparency to blinded pseudonymized lab data, adverse events, medical histories, concomitant medications, and use of IP, all in a single portal. This helps the Mineralys clinical team save time by getting all the information from across several different systems in Miracle.

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‍Looking Ahead

Our partnership with Mineralys Therapeutics represents a significant step forward in our mission to speed up clinical trials. We are excited to contribute to the development of new therapies that have the potential to improve the lives of countless patients. As we move forward, we remain dedicated to innovation, excellence, and the pursuit of better health outcomes.

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‍About Mineralys Therapeutics

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension and CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://www.mineralystx.com. Follow Mineralys on LinkedIn and Twitter.

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‍About Miracle

Miracle is revolutionizing clinical trial management by serving as the control room for clinical trial operations and data management. By integrating data from multiple platforms and providing real-time, actionable insights, Miracle empowers clinical teams to reduce inefficiencies, make data-driven decisions, and accelerate clinical trials. Our commitment to security and compliance ensures that all data is protected with the highest industry standards, allowing biotech companies to focus on what matters most – advancing medical science and improving patient outcomes.

For more information, visit our website or contact us at sales@miracleml.com.