Summary

  1 2 3
Unmet Need
  • Prevention of Myopia progression in children aged 7 to 17
  1. Reduce risk of ARDS Phase 1 Progressing to ARDS Phase 2 in Covid 19 Patients
  2. Improve Patient Post Covid 19 recovery
  • Prevention of preterm birth in pregnant women
Status
  • 12 years named patient use trial completed in Denmark
  • First therapeutic product globally for myopia control
  • Investigator clinical trial in 15 patients in October 2020 completed successfully
  • Novel dosage form with 500% improved bio-availability
  • First product globally
Clinical Phase & IP
  • Phase 3 Clinical Trial in 2024
  • 20 Years IP
  • Phase 3 double blind 180 clinical study completed
  • Patent Filed September 2020
  • Patent Filed September 2019
  • Phase 3 Clinical Trial 2024
Molecule

7 Methyl Xanthine

Ketone Ester

Algal DHA oil


Myopia Control

7-MX as an Oral Treatment for Myopia

7MX

7-MX

  • First solid oral tablet formulation for myopia control in children
  • Compelling safety profile with no short- or long-term adverse effects
    • Excreted mainly by kidneys within 12 hours with minimal liver metabolism, and does not easily cross blood brain barrier

7-MX: Mechanism of Action

  • 7-MX, a caffeine metabolite, is a non-selective adenosine receptor antagonist and increases dopamine transmission in human retinal pigment epithelium cells
  • 7-MX repairs loss of scleral tissue and scleral thinning known to be associated with myopia in mammals.
  • Increases posterior sclera thickness by increasing scleral collagen content and diameter of collagen fibrils
  • Prevents myopia progression, with significant efficacy in the 7-10 age group and without a risk of rebound effects
  • Additive efficacy when used in combination with optical devices
  • By blocking the effects of adenosine and increasing the thickness and biomechanical strength of the sclera, 7-MX prevents eye elongation

Timeline of the clinical use of 7-MX

Theialife Time line

Clinical usage in Denmark – Published in British Journal of Ophthalmology

 
7mx-article



7-MX: Published Research by Theialife

  1. Harjeet Singh, Harmanpreet Singh, Sunil Sharma, Harmanpreet Kaur, Arvinder Kaur, Satwinderjeet Kaur, Sandeep Kaur, Nikhil Shri Sahajpal, Alka Chaubey, Navid Reza Shahtaghi, Inderjeet Kaur & Subheet Kumar Jain (2023): Genotoxic and mutagenic potential of 7- methylxanthine: an investigational drug molecule for the treatment of myopia, Drug and Chemical Toxicology, DOI: 10.1080/01480545.2022.2164011
  2. Harjeet Singh, Nikhil Shri Sahajpal, Harmanpreet Singh, Vanita Vanita, Partha Roy, Surinder Paul, Shashank Kumar Singh, Inderjit Kaur & Subheet Kumar Jain (2019): Preclinical and cellular toxicity evaluation of 7-methylxanthine: an investigational drug for the treatment of myopia, Drug and Chemical Toxicology, DOI: 10.1080/01480545.2019.1635615
  3. Harjeet Singh, Harmanpreet Singh, Nikhil Shri Sahajpal, Surinder Paul, Inderjit Kaur & Subheet Kumar Jain (2022) Sub-chronic and chronic toxicity evaluation of 7-methylxanthine: a new molecule for the treatment of myopia, Drug and Chemical Toxicology, 45:3, 1383-1394, DOI: 10.1080/01480545.2020.1833904
  4. Nie HH, Huo LJ, Yang X, Gao ZY, Zeng JW, Trier K, Cui DM. Effects of 7-methylxanthine on form-deprivation myopia in pigmented rabbits. Int J Ophthalmol. 2012;5(2):133-7.
  5. Trier K, Olsen EB, Kobayashi T, et al ARVO (The Association for Research in Vision and Ophthalmology) sclera after treatment with 7-methylxanthine, theobromine, acetazolamide, or l-ornithine. British Journal of Ophthalmology 1999;83:1370-1375.
  6. Trier, K., Munk Ribel-Madsen, S., Cui, D. et al. Systemic 7-methylxanthine in retarding axial eye growth and myopia progression: a 36-month pilot study. j ocul biol dis inform 1, 85 (2008). https://doi.org/10.1007/s12177-008-9013-3
  7. Wan W, Cui D, Trier K, Zeng J. Effect of 7-methylxanthine on human retinal pigment epithelium cells cultured in vitro. Mol Vis. 2017 Dec 25;23:1006-1014. PMID: 29386874; PMCID: PMC5757859.
  8. Li-Fang Hung, Baskar Arumugam, Lisa Ostrin, Nimesh Patel, Klaus Trier, Monica Jong, Earl L. Smith III; The Adenosine Receptor Antagonist, 7-Methylxanthine, Alters Emmetropizing Responses in Infant Macaques. Invest. Ophthalmol. Vis. Sci. 2018;59(1):472-486. doi: https://doi.org/10.1167/iovs.17-22337.
  9. Cristaldi, M.; Olivieri, M.; Pezzino, S.; Spampinato, G.; Lupo, G.; Anfuso, C.D.; Rusciano, D. Atropine Differentially Modulates ECM Production by Ocular Fibroblasts, and Its Ocular Surface Toxicity Is Blunted by Colostrum. Biomedicines 2020, 8, 78. https://doi.org/10.3390/biomedicines8040078
  10. Liu, H., Schaeffel, F., Trier, K., & Feldkaemper, M. (2020). Effects of 7-methylxanthine on deprivation myopia and retinal dopamine release in chickens. Ophthalmic Research, 63(3), 347-357.
  11. Fan Y, Li J, Huang L, Wang K, Zhao M: 7-Methylxanthine Influences the Behavior of ADORA2A-DRD2 Heterodimers in Human Retinal Pigment Epithelial Cells. Ophthalmic Res 2022. doi: 10.1159/000525563
  12. Cui D, Trier K, Zeng J, Wu K, Yu M, Hu J, Chen X, Ge J. Effects of 7-methylxanthine on the sclera in form deprivation myopia in guinea pigs. Acta Ophthalmol. 2011 Jun;89(4):328-34.
  13. Wan W,Cui D, Trier K, Zeng J. Effect of 7-methylxanthine on human retinal pigment epithelium cells cultured in vitro. Mol Vis. 2017 Dec 25;23:1006-1014. PMID: 29386874; PMCID: PMC5757859.
  14. Cristaldi M, Olivieri M, Pezzino S, Spampinato G, Lupo G, Anfuso CD, Rusciano D. Atropine Differentially Modulates ECM Production by Ocular Fibroblasts, and Its Ocular Surface Toxicity Is Blunted by Colostrum. Biomedicines. 2020 Apr 5;8(4):78. doi: 10.3390/biomedicines8040078. PMID: 32260532; PMCID: PMC7236597.
  15. Wan W, Cui D, Trier K, Zeng J. Effect of 7-methylxanthine on human retinal pigment epithelium cells cultured in vitro. Mol Vis. 2017 Dec 25;23:1006-1014. PMID: 29386874; PMCID: PMC5757859.
  16. ARVO (The Association for Research in Vision and Ophthalmology) Annual meeting 2020 Abstract Number: 1136 Authors: Safal Khana , Thomas T. Norton , Timothy Gawne Optometry and Vision Science, University of Alabama at Birmingham, Birmingham, Alabama, United States;
  17. Trier K, Cui D, Ribel-Madsen S, et al. Oral administration of caffeine metabolite 7-methylxanthine is associated with slowed myopia progression in Danish children. British Journal of Ophthalmology Published Online First: 22 August 2022. doi: 10.1136/bjo-2021-320920. Follow on Clinical Trial: Clinical experience in Denmark of controlling paediatric Myopia progression in Children. 1171 patients treated by Dr. Klaus Trier, MD Ophthalmology using our novel drug 7 Methyl Xanthine. No adverse effects were reported during this period to the Danish Medicines Agency (“DMA”).

Pre – Term Birth

A Global Issue - 150 million new births each year

15 million babies born too soon every year

  • 1 in 10 babies born preterm
  • 1 million children die each year
  • Many survivors face a lifetime of disability, including learning disabilities and visual and hearing problems

Investment in women’s and maternal health and care at birth will reduce pre-term birth rates and improve outcomes for women and newborn pre-term babies.

Rates of preterm birth rising

  • Preterm birth rates increasing in almost all countries
  • Prematurity leading cause of newborn deaths (babies in the first 4 weeks of life);
  • 2nd leading cause of death after pneumonia in children under age 5.

Investment in women’s and maternal health and care at birth will reduce pre-term birth rates and improve outcomes for women and newborn pre-term babies.

Pre-Term Births- WHO Report

Every year, an estimated 15 million babies are born preterm (before 37 completed weeks of gestation), and this number is rising.

Preterm birth complications are the leading cause of death among children under 5 years of age, responsible for approximately 1 million deaths in 2015 (1).

Three-quarters of these deaths could be prevented with current, cost-effective interventions. Across 184 countries, the rate of preterm birth ranges from 5% to 18% of babies born.

The 10 countries with the greatest number of preterm births(2)
India 35,19,100
China 11,72,300
Nigeria 7,73,600
Pakistan 7,48,100
Indonesia 6,75,700
United States of America 5,17,400
Bangladesh 4,24,100
Philippines 3,48,900
Democratic Republic of the Congo 3,41,400
Brazil 2,79,300

Pre-Term Births and Long Term Effects

Preterm Birth Prevention - Current Therapy options

Progesterone Therapy, Corticosteroid Therapy, Tocolytics Therapy, Antibiotics Therapy, Heparin Prophylaxis therapy amongst others, through oral, parenteral, or vaginal routes.

Two recent trials investigating preterm birth did not find beneficial effect of progesterone. No effect on child development. Outcomes after first trimester progesterone are unclear.

FDA Advisory Board Votes to Recommend Withdrawing Progesterone Therapy for Preterm Birth

Nine members of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee have voted to recommend that the FDA pursue withdrawal of approval for hydroxyprogesterone caproate injection for the prevention of preterm birth in pregnant women, while 7 of the committee’s members voted to leave the product under accelerated approval and to require a new confirmatory trial.

  • Survival of the littlest: the long-term impacts of being born extremely early
  • https://www.who.int/news-room/fact-sheets/detail/preterm-birth
  • Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, et al. A randomized trial of progesterone in women with recurrent miscarriages. N Engl J Med 2015; 373: 2141– 8.
  • Coomarasamy A, Devall AJ, Cheed V, Harb H, Middleton LJ, Gallos ID, et al. A randomized trial of progesterone in women with bleeding in early pregnancy. N Engl J Med 2019; 380: 1815– 24.
  • https://www.pharmacytimes.com/news/fda-advisory-board-votes-to-recommend-withdrawing-progesterone-therapy-for-preterm-birth