New Drug for Brain Edema

This single-center, randomized, double-blind, placebo-controlled phase I clinical study plans to enroll 56 subjects to evaluate tolerability, safety and pharmacokinetic characteristics after single/multiple administration in healthy Chinese volunteers. Professor Wang Yongjun, Dean of Beijing Tiantan Hospital, Capital Medical University is the principal investigator. The study was officially launched on December 2nd, 2021, with the first dose of 4 subjects in the first dosing group completed on the 8th of December.

“The start of dosing in Simcere’s first clinical study of SIM0307 is another important step forward in the global development of AER-271 as we seek to establish a needed, meaningful therapy for acute ischemic stroke,” said Mike Gresser, Chief Scientific Officer of Aeromics. Gresser added, “tPA and other thrombolytic treatments result in reperfusion, which is necessary, but often lead to reperfusion injury. Treatment with AER-271 alongside thrombolytic therapy is expected to help reduce edema by intervening early in the inflammatory process resulting from reperfusion by tPA, manual thrombectomy and other thrombolytic treatments.”

Aeromics and Simcere entered into a collaboration and exclusive license agreement in November 2019 for AER-271, a clinical-stage anti-edema therapy being developed to treat stroke and other indications in Greater China (mainland China, Hong Kong, Macau and Taiwan). According to the agreement, Simcere will be responsible for the clinical development and commercialization of AER-271 in Greater China. In April 2021, the China National Medical Products Administration (NMPA) approved a clinical trial of SIM0307 for the indication of cerebral edema after acute severe ischemic stroke.

“We are very pleased to see SIM0307 reach an important milestone in China.” said Dr. Renhong Tang, Executive Director and Executive Vice President of Simcere, “The rapid advancement of this molecule underscores the combined world-class talents of Aeromics and Simcere R&D, clinical development, manufacturing, and commercialization.”

“We continue to appreciate our relationship with Simcere as our teams work closely to advance this program. Everything we believed about their research, development and manufacturing strengths have proven true, and the collaborative nature of their team has exceeded our expectations. We are delighted to see Simcere’s progress as we prepare for our own Phase IIa proof-of-mechanism trial here in the United States.” said Thomas Zindrick, Aeromics’ Executive Chairman.

Simcere’s Executive Chairman & CEO, Mr. Jinsheng Ren concluded, “We are proud to be developing SIM0307 (AER-271), as we translate Nobel-winning biology into meaningful therapeutics for seriously-ill patients with very limited treatment options.  Additionally, SIM0307 has potential to synergize with other products in Simcere’s CNS portfolio such as Sanbexin® that may further improve the outcome of stroke patients.which was developed to translate . We look forward to future exciting progress in partnership together with the Aeromics team.”