ALMB-0166 / CSPC Pharma - LARVOL DELTA

Safety, tolerability and preliminary efficacy of ALMB-0166 in patients with acute spine cord injury. (PubMed, Brain Commun) - "Specifically, two patients in the ALMB-0166 group recovered from AIS Grade C to Grade E, whereas no patient in the placebo group recovered to Grade E. Notably, the 1200 and 2400 mg dose groups showed superior efficacy in sensory and motor measures; pooled data from these two groups showed greater improvements in both sensory and motor scores than those in the placebo group. In conclusion, ALMB-0166 demonstrated a manageable safety profile and improved neurological recovery in patients with acute SCI."

Journal • CNS Disorders • Inflammation • Orthopedics • Pain

Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: AlaMab Therapeutics (Shanghai) Inc. | Recruiting ➔ Completed | N=45 ➔ 24 | Trial completion date: Apr 2024 ➔ Feb 2025 | Trial primary completion date: Dec 2023 ➔ Feb 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

ALMB-0166 developed by the Group has obtained approval from the National Medical Products Administration of the People’s Republic of China to conduct a Phase II clinical trial in China to evaluate its efficacy in patients with Parkinson’s disease (HKEXnews)

New P2 trial • Parkinson's Disease

Safety, Tolerability and Efficacy of ALMB-0166 in the Patients with Acute Spine Cord Injury (SCI): A Multicenter, Randomized, Placebo-controlled, Phase I/II Study (AAN 2025) - "At day 56, patients treated with ALMB-0166 had improvement as compared with those given placebo in motor function (scores increased from baseline by 66.0 for 2400 mg and 45.6 for placebo), sensatory function (scores increased by 77.5, 62.7 for 600, 1200 mg and 52.3 for placebo), AIS (2 patients recovered from grade C to grade E for ALMB-0166 and 0 patient recovered to grade E for placebo), and pain (VAS scores decreased by 44.3, 23.7 for 1200, 2400 mg and 20.9 for placebo). Conclusions ALMB-0166 demonstrated great safety profile and improved neurologic recovery in patients with acute SCI."

Clinical • Late-breaking abstract • P1/2 data • Cardiovascular • CNS Disorders • Heart Failure • Hematological Disorders • Inflammation • Pain • Pneumonia • Respiratory Diseases • Thrombosis

Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: AlaMab Therapeutics (Shanghai) Inc.

New P1 trial • CNS Disorders • Orthopedics