In-depth Look

AMCKAUS Pharm Completed Dosing of SAD in Phase I Clinical Trial of Aom0315 in Australia

HANGZHOU,China, November 22, 2023- AMCKAUS Pharm (Australia branch of Adamerck) completed dosing of single ascending dose phase I clinical trial of Aom0315 conducted in healthy subjects in Australia on November 22, 2023. Unblinded data indicated that Aom0315 is well tolerated and safe in all groups, in which the highest dose is 10 times higher than the effective dose found in preclinical studies.

Phase I clinical trial of Aom0315 including SAD and MAD studies and food effects study, dosing of all subjects is expected to be completed in January 2024. The IND application for Phase II clinical trial is anticipated by June 2024.

As the first product in Adamerck Pharm's cardiovascular pipeline to enter clinical trials, Aom0315 represents a significant milestone not only for the product itself but also for Adamerck Pharm's advancement in the cardiovascular field.

About Clinical Study

A single ascending dose and multiple ascending dose single-center, double-blind, placebo-controlled, randomized Phase I clinical study was conducted   to evaluate the safety, tolerability and pharmacokinetic profile of oral taken Aom0315 in healthy subjects.

In this clinical study, 78 healthy subjects are planned to be enrolled, with 64 having already completed dosing. The administered doses ranged from 120 mg to 1200 mg (, NCT05650528).

About Aom0315

Aom0315 is an oral neuroprotective agent, indicted to protect more than 100 million ischemic stroke patients worldwide against neurological damage. Preclinical studies data has shown that Aom0315 significantly reduced cerebral infarctionrate and improved neurological function scores in rat model with focal andpermanent cerebral ischemia. The indicators associated with anti-ischemic cerebral protective effects significantly out performed those of existing neuroprotective drugs on the market.

In addition, Aom0315 provides cardiovascular and cerebrovascular protection and has unique property of anticoagulation without bleeding.

In the area of cardiovascular and cerebrovascular diseases,   orthopaedic surgery, severe infections and advanced tumours, thrombotic diseases and its resultant pulmonary embolism, cerebral embolism   and other common complications result in high morbidity, disability and mortality in clinical. Application of anticoagulants to prevent and control thrombosis is a consensus in the clinic at present. However, preventing thrombosis with anticoagulants may lead to bleeding in clinical settings. It is difficult to balance the risk and benefit of anticoagulation and bleeding.

Aom0315, as a small molecular anticoagulant, is expected to address clinical needs of anticoagulation without bleeding, and can be widely used for thrombosis prevention and treatment.

About Aomo Pharm

Aomo Pharm (the US branch of Adamerck) is a biotechnology company cofound by Ph.D. Youmao Qi and Qing Jie in 2000. Since establishment, Aomo is driven by a culture of innovation as core value and commits to bringing   better drugs for better lives. We apply scientific expertise and proprietary technology platform AMDCx to develop and commercialize high-quality innovative drug for unmet clinical needs.

We have a pipeline of more than 10 first-in-class drug candidates under development for anesthesia, eye diseases, cardiovascular-cerebrovascular diseases and cancers. Adamgammadex (Aom0498) is one of our patented drug products, which is a best-in-class   targeting neuromuscular block reversal agent. Two phase III pivotal clinical trials of adamgammadex in China have been completed and   the NDA approval is estimated to be received in China at the earliest in 2024. The end-of-phase II meeting with the US FDA for Adamgammadex has been successfully completed on September 28, 2022. Mutil-regional clinical trials in the US, Europe and Japan are scheduled to initial in 2024.