THEIALIFE SCIENCES: A Disruptive Clinical Stage Novel Ophthalmology Asset
November 22, 2023
In a recent webinar hosted by MSQ Ventures, Dr. Klaus Trier, co-founder, and CTO of THEIALIFE SCIENCES, provided unprecedented insights into the world's first phase three ready oral treatment for myopiocontrol in children, 7-MX (7-methylxanthine). This groundbreaking solution has captured global attention for its potential to revolutionize myopia treatment.
The Genesis of THEIALIFE SCIENCES:
Dr. Trier's exploration of connective tissue research led him to focus on the sclera, linking weak sclera to myopia. This journey culminated in the discovery of a unique molecule—a metabolite of caffeine—that could increase collagen concentration in the sclera. Collaborating with Mr. Sandeep Arora of BioPlus Bangalore, India, marked a decade-long partnership, overcoming challenges in producing the active pharmaceutical ingredient (API).
THEIALIFE's First-in-Class Molecule:
Dr. Trier detailed the distinctive features of 7-MX, emphasizing its oral form for myopiocontrol in children. This extended-release tablet offers a convenient alternative to traditional eye drops, with potential advantages over existing treatments like atropine eye drops and optical devices.
Clinical Development and Future Outlook:
The discussion transitioned to the future of THEIALIFE SCIENCES, focusing on the clinical development of ND10, the extended release tablet. Dr. Trier highlighted ongoing discussions with regulatory agencies and acknowledged the challenges involved in bringing this groundbreaking treatment to market within a realistic timeframe.
Funding the Future:
Addressing the financial aspect, Dr. Trier acknowledged THEIALIFE's current capital raise fund rounds to support future trials. He emphasized the crucial role funding plays in advancing their revolutionary myopia treatment.
Presentation Highlights:
The presentation emphasized the critical issue of increasing myopia rates globally, predicting that by 2050, half of the world's population will be short-sighted.
The core problem discussed was the lack of an approved drop for myopia control, and the limitations of relying solely on optical devices. The speaker highlighted the inefficacy of current treatments, such as atropine, and presented THEIALIFE's innovative approach with their proprietary molecule, 7-MX.
The pipeline of THEIALIFE's products extended beyond myopia, encompassing a range of ophthalmic solutions, including cancer prevention, dry eye disease, cornea blindness, and vascular diseases. The focus, however, remained on the myopia project, with an in-depth discussion on the mechanism of action of 7-MX.
Key findings from clinical data were presented, demonstrating a significant reduction in myopic progression, particularly in children aged seven to 10. The efficacy of 7-MX surpassed competitors, with a 75% average reduction, well above the FDA's minimum requirement of 30%.
The speaker also discussed the safety profile of 7-MX, citing positive results from basic toxicology studies up to six months. The molecule's history of use, spanning thousands of years, further supported its safety.
Looking ahead, THEIALIFE is gearing up for a global Phase 3 trial, targeting children aged 7 to 12. The presentation outlined the trial's structure, safety considerations, and anticipated timeline. A funding goal of $60 million was highlighted to cover the trial, regulatory costs, and establish a US headquarters.
Q&A Session Highlights:
Addressing the Myopia Epidemic:
The discussion shifted to the critical issue of myopia becoming a leading cause of irreversible vision impairment. Dr. Trier underscored the risks associated with myopia development in children, particularly below the age of 10, emphasizing the urgent need for preventative measures.
Understanding the Mechanism:
Dr. Trier explained the scientific underpinnings of THEIALIFE SCIENCES' solution, focusing on the correlation between collagen concentration in the posterior sclera and eye elongation. The interview highlighted how 7MX enhances collagen concentration, addressing the root cause of myopia progression.
Challenges and Triumphs in Development:
Insights into the challenges faced during the industrial phase of the project were shared, spanning two decades from initial discovery to clinical trials and industrial-scale production. The collaboration with the Danish medicines agency and Indian partners emphasized the importance of sustainable production.
Myopia Management Landscape: Opportunities and Challenges:
The interview explored the broader landscape of myopia management, discussing challenges in indoor-centric lifestyles, especially in East Asia. THEIALIFE SCIENCES' solution was positioned as a potential business opportunity with a significant societal impact.
Regulatory Pathways:
Participants sought clarity on the regulatory pathway for 7-MX. Dr. Trier elaborated on ongoing discussions with regulatory agencies and emphasized the commitment to meeting all requirements.
Treatment Accessibility:
Questions arose regarding the accessibility of the treatment, especially in regions with high myopia prevalence. Dr. Trier addressed plans for global distribution and collaborations to ensure broad accessibility.
Long-Term Vision:
The discussion concluded with insights into THEIALIFE SCIENCES' long-term vision, unveiling plans for addressing keratoconus and neurovascular AMD. The pipeline of proprietary projects signifies a commitment to continued innovation, promising a bright future for THEIALIFE SCIENCES.
THEIALIFE SCIENCES emerges not only as a responder to a medical need but as a pioneer in transforming ophthalmology. Dr. Klaus Trier's groundbreaking discoveries open new doors for preventive eye care, offering hope to countless individuals at risk of irreversible vision impairment. THEIALIFE SCIENCES' long-term vision promises a future where innovative solutions redefine the landscape of ophthalmological treatments. The webinar provided a comprehensive overview of THEIALIFE SCIENCES' journey, challenges, and aspirations, leaving the audience eagerly anticipating the next chapter in the evolution of myopia management and beyond.