Milan, Italy (October 31, 2024)

Today, MgShell, a MedTech company that aspires to inspire a change in ophthalmology by developing a magnesium-based drug delivery platform capable of reshaping patient care and enhancing treatment adherence for patients suffering from retinal diseases, announced the results about its pre-clinical animal safety study.

Study Overview

MgShell is proud to announce the successful completion of a groundbreaking pre-clinical study aimed at assessing the safety and tolerability of its magnesium-based drug delivery system. This two-month chronic study, conducted on animal models, marks a significant milestone in the development of innovative ocular drug delivery solutions.

To date, no other research has demonstrated the safety of magnesium-based drug delivery systems in the eyes of animal models. MgShell is proud to be a pioneer in this field, setting the stage for the advancement of this promising technology in ocular therapeutics.

Study Design and Methodology

The study was conducted over a period of two months using six animals under carefully controlled conditions. The primary focus was to evaluate the chronic tolerability of the magnesium-based carrier when administered without an active pharmaceutical ingredient, ensuring an accurate assessment of its intrinsic safety profile.

Key details include:

• Duration: 8 weeks (chronic exposure)
• Subjects: 6 animals
• Focus: Tolerability of the magnesium-based carrier alone
• Administration: Intravitreal implantation

To assess biocompatibility comprehensively, the study involved:

• Ophthalmological Examinations: Including slit-lamp biomicroscopy, indirect ophthalmoscopy, ultrasound imaging, and rebound tonometry to monitor ocular health.
• Electroretinography (ERG): Evaluating retinal function under dark and light-adapted conditions.
• Histological Analysis: Post-study examination of treated and control eyes for any signs of inflammation, toxicity, or structural damage.
• Systemic Evaluations: Monitoring blood magnesium levels and systemic inflammation markers through regular blood tests.

The study adhered to the highest ethical standards and regulatory guidelines, ensuring precision and integrity in every aspect of the research process.

Key Findings

The study yielded highly promising results:

1. Tolerability: The magnesium-based carrier was well tolerated across the two-month study period, with no significant adverse effects observed in any of the subjects.
2. Safety: The absence of toxic reactions provides strong evidence supporting the long-term safety of this carrier in ocular applications.
3. Pioneering Results: MgShell is the first to establish a safety profile for magnesium-based drug delivery systems in the eyes of animal models, a groundbreaking achievement that opens the door to new therapeutic possibilities.

Implications and Next Steps

The successful completion of this study establishes a robust foundation for further research and development. Having demonstrated the safety and tolerability of the carrier, MgShell now aims to integrate active pharmaceutical ingredients in future studies to explore the efficacy of the system for targeted ocular treatments.

Preparations are underway to transition to additional pre-clinical studies and subsequent clinical trials, advancing MgShell’s mission to revolutionize drug delivery for ocular conditions.

Acknowledgments

We extend our deepest gratitude to the dedicated research team and collaborators whose expertise and commitment made this study possible. Among other, CRABCC Srl (in the person of Dr. Alessandro Addis), Dr. Laura Barachetti, Dr. Chiara Giudice, Dr. Irene Cancelli and Life & Device Srl. MgShell’s pioneering work underscores our relentless drive to innovate and improve therapeutic outcomes for patients around the world.

About MgShell:

MgShell, headquartered in Milan, Italy, is a preclinical-stage drug delivery company focused on developing a magnesium-based drug delivery platform capable of reshaping patient care, enhancing treatment adherence for patients suffering from retinal diseases, and lowering healthcare expenses.