(1) Phase I Clinical Trial
SPACEMED-X’s innovative patented drug, CARDIX-101, has successfully concluded its Phase I clinical study, demonstrating the drug’s safety profile and absence of significant side effects. Conducted between 2018 and 2020 at Sulpizio Cardiovascular Center in UC San Diego Health, the Phase I trial, titled “A Single Ascending Dose Clinical Study to Establish Safety and Tolerability of CARDIX-101 in Bradycardia Patients,” adhered to FDA and ICH Good Clinical Practice (GCP) guidelines. The study involved eighteen patients who were administered six ascending single-dose levels of the investigational drug.
Throughout the trial, no adverse effects related to CARDIX-101 were observed or reported for any of the participants, indicating a favorable safety and tolerability profile for the drug. This positive outcome marks a significant milestone in the development of CARDIX-101, paving the way for further research into its potential applications in addressing cardiovascular challenges associated with space exploration and human activities in the universe.
(2) Phase IIA Clinical Trial
SPACEMED-X has reached a significant milestone with the successful conclusion of the Phase IIA clinical safety and efficacy study for its innovative, patented drug, CARDIX-101. The study results underscored the drug’s safety, its lack of major side effects, and its effectiveness as a therapeutic solution.
The investigation, entitled “An Exploratory Safety and Efficacy Study of CARDIX-101 for the Treatment of Chronic Bradycardia,” concluded in June 2023 and was carried out across three distinct clinical locations in the United States. Twenty-seven participants successfully finished the 14-day study, each receiving a thrice-daily dosage of CARDIX-101. The study protocol mandated continuous monitoring of heart rate (HR) and electrocardiogram (ECG) readings throughout the investigation. Medical examinations of rigorous nature were performed before and after the drug’s administration, a systematic approach that furnished invaluable data.
These procedures and findings confirmed that no significant adverse events or QT dispersion could be traced back to the trial drug, reinforcing the safety of CARDIX-101 for patients. This detailed, meticulous approach provided a strong foundation for establishing the safety profile of CARDIX-101, marking an essential milestone in its path toward potential therapeutic use.
The study’s insights into the drug’s efficacy were as noteworthy as its safety results. An exhaustive statistical analysis of patient data, employing a consolidated analysis of variance (ANOVA), disclosed that CARDIX-101 instigated a significant elevation in participants’ heart rates. This increment varied from 20% to 41% (p-value < 0.001), contingent on each individual’s response during sleep and wake cycles, leading to a remarkable improvement in cardiac function.
Additionally, the hypothesis was that the patient’s stroke volume would remain virtually unaltered pre and post-administration of CARDIX-101. Consequently, the boost in cardiac output could be proportionally linked to the observed augmentation in heart rates. These observations solidly affirmed the projected efficacy of CARDIX-101. The results thus provide compelling evidence of the drug’s potential as a potent therapeutic solution.
In conclusion, the Phase IIA clinical study has yielded encouraging findings, substantiating both the safety and efficacy of CARDIX-101 for treating chronic bradycardia. The outcomes unearth the enormous potential of CARDIX-101 to revolutionize cardiovascular medicine. This is particularly significant in the realm of space exploration.
As the exploration of this innovative drug continues, it presents a substantial promise to enhance cardiac health among astronauts and space settlers. Specifically, it offers the potential to counteract the cardiac challenges posed by microgravity environments and radiation exposure. This could contribute to the successful expansion of human civilization beyond our planet. The continued success of CARDIX-101 promises to be a significant milestone in the annals of space medicine, helping to improve the health and well-being of humans in the multi-planetary colonization endeavors.
(3) Regulatory Approval
SPACEMED-X’s patented drug offers two applications: it serves as an alternative to pacemakers for treating chronic bradycardia and as a space medicine innovation aimed at enhancing cardiac output for astronauts or space travelers, especially in microgravity and radiation-exposed environments. We are fully committed to conducting further clinical trials and communicating transparently with the FDA to secure regulatory approval for our groundbreaking, cardiac function-enhancing drug.
To expedite approval, we have sought an Orphan Drug Designation from the FDA Office of Orphan Product Development, a designation. With the pursuit of the Orphan Drug Designation and through diligent collaboration with the FDA, we aim to fast-track the approval. This would enable us to contribute more effectively to space science research and efforts to colonize other planets. Guided by our steadfast commitment to advancing human space exploration, we firmly believe that our innovative drug can be crucial in ensuring the health and longevity of astronauts and space settlers. Our vision is to play an integral role in successfully expanding human civilization beyond Earth.
