New Haven, Connecticut, USA and Nanjing, China, 8th December 2021 – Simcere Pharmaceutical Group and Aeromics, Inc. today announced that Simcere dosed the first subjects in the SIM0307 (AER-271) Phase I study conducted in Beijing Tiantan Hospital.
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 2nd December 2021, with the first dose of 4 subjects in the first dosing group completed on 8th 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（AER-271） 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, as we translate Nobel-winning biology into meaningful therapeutics for seriously-ill patients with very limited treatment options. Additionally, SIM0307 has the potential to synergize with other products in Simcere's CNS portfolio, such as Sanbexin® that may further improve the outcome of stroke patients. We look forward to future exciting progress in partnership together with the Aeromics' team."
About stroke end edema
Every 20-30 seconds someone in China suffers from a stroke. Roughly 2,500,000 strokes are seen in China each year, many of which suffer life-threatening and severely disabling cerebral edema or brain swelling, and may benefit from an anti-edema medication.
About SIM0307（AER-271）
SIM0307 is a first-in-class, proprietary, intravenous (IV) prodrug that delivers AER-270, a potent inhibitor of AQP4 water channels for the treatment of cerebral edema (brain swelling) in patients that have suffered ischemic strokes. Aquaporin-4 (AQP4) water channels are the primary route of water movement into the central nervous system under conditions of ischemia. SIM0307 is an investigational drug that has successfully completed a Phase I study and is not yet approved by any regulatory agency.
About Aeromics
Aeromics is a privately held, clinical-stage pharmaceutical company dedicated to fundamentally changing the way various conditions resulting from the loss of water homeostasis are treated.
For more information, please visit www.aeromics.com
About Simcere
Simcere Pharmaceutical Group limited (2096. HK) is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with the mission of "providing today's patients with the medicines of the future." With an established national key laboratory of translational medicine and innovative pharmaceuticals, Simcere focuses on the three main therapeutic areas of oncology, central nervous system diseases and autoimmune diseases. The company has developed a diversified product portfolio and industry-leading capabilities through its vigorous in-house R&D efforts and extensive R&D collaborations. In an effort to bring more global life science breakthroughs to China, Sincere continues strategically collaborate with world-leading pharmaceutical companies and biotechnology companies.
For more information, please visit: www.simcere.com
Forward Looking Statements
Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.