In-depth Look

Aom0315 Completes the Enrollment and Safety Follow-Up of All Subjects for Phase I Clinical Trails

HANGZHOU, China, January 31, 2023-The Phase I clinical trial of Aom0315, an innovative drug with a novel target, officially reached its Last Patient Last Visit (LPLV) in Australia. This milestone signifies the completion of the Aom0315-ACT-01 clinical trial and the commencement of the critical data cleaning phase. The successful completion of participant dosing in the Australian Phase I clinical trial is a significant milestone in the development journey of Aom0315, establishing a solid foundation for the subsequent Phase II clinical trials.


Aom0315 is a novel molecular compound in the cardiovascular and cerebrovascular field, independently developed by Aomo Pharma Inc.(the US branch of Adamerck), holding full proprietary intellectual property rights. As a targeted therapeutic drug, current Phase I clinical trial data ina healthy Australian cohort indicate favorable pharmacokinetic parameters andsafety profiles, with no similar market-available drugs targeting the sameindications.


The World Heart Federation's "WORLD HEART REPORT 2023" highlights that cardiovascular diseases have been the leading cause of death globally for decades. In 2021, nearly 20.5 million deaths were attributed to cardiovascular diseases, accounting for about a third of all global deaths. The number of cardiovascular deaths increased from 12.1 million in 1990 to 18.6 million in2019. In 2019,   cardiovascular diseases accounted for 33% of all global deaths, with ischemic heart disease (9.1 million deaths) and stroke (6.6 million deaths) contributing to 85% of the total cardiovascular deaths.


The situation in China is similarly concerning. The National Center for Cardiovascular Diseases released the "China Cardiovascular Health and Disease Report 2022" in June 2023. The report indicates a rising incidence and mortality rate of cardiovascular diseases in China due to unhealthy life styles, a significant population with cardiovascular risk factors, andaccelerated population aging. The inflection point for decreasing disease burden has not yet been reached. The prevalence of cardiovascular diseases (CVD) is continuously rising, with an estimated 330 million people currently affected. In 2020, CVD remained the leading cause of death, surpassing cancer and other diseases.


Globally, including in Western developed countries and China, cardiovascular diseases are the leading cause of death. Diseases such as arrhythmia, myocardial hypertrophy, heart failure, and stroke remainchallenging to treat, highlighting an unmet clinical need for innovative drugsto bridge the significant health care gap. Aom0315 specifically targets the KCa2 ion channel and has mitochondrial protective effects. Preclinical efficacy demonstrates significant benefits in anti-arrhythmic, anticoagulant, myocardial remodeling inhibition (improving myocardial hypertrophy and cardiac function), and neuroprotection. Aom0315 holds promise as a precise targeted drug for hundreds of millions of cardiovascular and cerebrovascular disease patients worldwide, offering a more effective and safer treatment option.


References:

1.World Heart Federation. WORLD HEART REPORT 2023.

2.National Center for Cardiovascular Diseases. China Cardiovascular Healthand Disease Report 2022.


About Aom0315-ACT-01 Clinical Trial

The Aom0315-ACT-01 is a single-center, randomized, double-blind,placebo-controlled Phase I clinical study aimed at evaluating the safety,tolerability, and pharmacokinetic properties of single (SAD) and multiple doses (MAD) of oral Aom0315 in healthy participants. This clinical study (Clinicaltrial.gov, NCT05650528) was approved by the Australian TGA on February16, 2023, and has successfully enrolled 78 healthy Australian participants,completing the study with doses ranging from 120 mg to 1200 mg, a nearly ten fold escalation, demonstrating excellent safety and tolerability.


About Aomo

Aomo Pharma Inc. (the US branch of Adamerck) is dedicated to the research of innovative drugs with independent intellectual property rights that are urgently needed globally. Adhering to the corporate mission of "Better Drugs for Better Lives" we have devoted over two decades to the research and development of new drugs. Currently, our company boasts a pipeline of more than ten innovative drugs with independent intellectual property rights. These products span various application fields such as anesthesia, cardiovascular and cerebrovascular, and ophthalmology. We are engaged in the commercial development of these products on a global scale, and they hold significant clinical value and broad market prospects. Among these, Aom0498 has entered the Pre-NDA phase and is expected to become the only patented drug globally in the muscle relaxation antagonist field. Aom0499, Aom0319, and Aom0315 have allentered clinical studies at both international and national levels, with pipeline advancements in Phases I to III. Our company continues to embrace the philosophy of innovative development, focusing on the innovative design of drugs and the industrialization of new drug development as our core competitive strengths. Leveraging the professional skills and management advantages of ourteam of returnees, we integrate resources for the global development of new drugs. We are committed to continuously promoting the research, development, and market launch of new drugs with independent intellectual property rights, aspiring to become a global leader in the pharmaceutical industry within our specialized fields.