Risen Pharma, a clinical-stage biotech company focusing on the development and commercialization of high-need, patient-accessible therapeutics, today announced that the first participant has been dosed in a Phase 2 clinical study in China of RP902, an oral small-molecule drug developed to address significant unmet medical needs in patients with Alzheimer's disease.
The clinical trial (NCT07579884, CTR20261318) is a multicenter, randomized, double-blind, placebo-controlled phase study to evaluate the safety and efficacy of RP902 in the treatment of mild cognitive impairment (MCI) due to Alzheimer’s Disease. The primary endpoint is the change from baseline in the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) score.
The study is co-led by Professor Yongjun Wang from Beijing Tiantan Hospital affiliated to Capital Medical University, and Professor Yi Tang from Xuanwu Hospital affiliated to Capital Medical University, and will enroll approximately 360 participants across around 50 clinical sites throughout China.
Alzheimer's disease (AD) is a progressive neurodegenerative disorder affecting cognition and daily functioning. In China, the prevalence of Alzheimer's disease among people aged 65 and above has reached 6.0%, with approximately 1 in every 17 individuals affected1, highlighting a significant unmet need for therapies with improved efficacy, safety, and patient adherence.
About RP902
RP902 is an oral small-molecule drug for AD, targeting patients with mild cognitive impairment (MCI) due to Alzheimer's disease(AD) who are apolipoprotein E ε4 (ApoE ε4) carriers, with the potential to become a first-in-class disease-modifying therapy. ApoE ε4 carriers typically experience earlier disease onset and faster progression, with limited treatment options currently available.
Preclinical studies of RP902 have demonstrated significantly inhibits neurotoxic Aβ oligomers and improves cognitive function. RP902 has completed Phase 1 clinical trials with favorable safety and tolerability and has initiated Phase 2 clinical studies (NCT07579884, CTR20261318).
Compared with existing therapies, RP902 has the potential to delay disease progression, with a favorable safety profile and the convenience of oral administration, offering a differentiated treatment option for Alzheimer's disease patients carrying the ApoE ε4 allele.
About Risen (Shanghai) Pharma Tech Co., Ltd.
Risen Pharma is an internationally competitive clinical-stage biotech company focusing on developing and commercializing highly-needed, patient-accessible therapeutics. The company's integrated capabilities cover all stages of drug development, including lead identification and optimization, preclinical evaluation, clinical development, and commercialization. Risen specializes in neurodegenerative diseases like Alzheimer’s, leveraging small molecules, PROTACs, and siRNA technologies to develop a comprehensive therapeutic platform encompassing prevention through treatment. Based on strong in-house R&D capabilities, the company has established a differentiated pipeline in degenerative and metabolic diseases, autoimmune diseases, cancers, and infectious diseases.
References
1. LI, Y. F., & JI, Y. (2026). Consensus on diagnostic criteria for Alzheimer's disease. Chinese Journal of Contemporary Neurology & Neurosurgery, 26(2).