Jul 09, 2025
At the EAN 2025 Congress, investigators from Peking Union Medical College Hospital and CSPC Pharmaceutical Group presented first-in-human clinical data from the Phase I/II randomized, placebo-controlled trial evaluating ALMB-0166 in patients with acute cervical spinal cord injury (SCI). ALMB-0166 is a first-in-class humanized monoclonal antibody that blocks connexin-43 hemichannels in astrocytes, an emerging target thought to mitigate secondary injury and promote neuroregeneration after SCI.
EAN 2025 Coverage: Safety and Efficacy of Almb-0166 in Patients With Acute Spine Cord Injury (SCI): A Randomized, Phase I/II Study
The study enrolled 24 adult patients with acute traumatic SCI (levels C3–C7), American Spinal Injury Association (ASIA) Impairment Scale (AIS) Grades B or C, within 72 hours of injury. Participants were randomized to receive a single IV dose of ALMB-0166 (200–4800 mg) or placebo, alongside best supportive care. The primary objective was to assess safety and tolerability, with motor, sensory, and functional outcomes evaluated over 56 days.
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Dosing Arms
Safety Profile
ALMB-0166 was well tolerated at all doses, with fewer high-grade AEs than placebo.
| Safety Endpoint | ALMB-0166 (n = 17) | Placebo (n = 7) |
| Any TEAE | 94.1% | 100% |
| ≥Grade 3 TEAEs | 17.6% | 42.9% |
| Common Grade ≥3 Events | Hypokalemia, pulmonary inflammation, respiratory failure, deep venous thrombosis | Hypokalemia, hyponatremia |
Preliminary Efficacy Signals at Day 56
Patients receiving ALMB-0166 showed clinically meaningful improvements in motor, sensory, and functional scores versus placebo. These early signs of neurologic improvement and pain reduction support the therapeutic rationale of targeting astrocytic connexin-43 in the acute injury phase.
| Endpoint | ALMB-0166 | Placebo |
| Motor score change (2400 mg) | +66.0 | +45.6 |
| Sensory score change (600–1200 mg) | +77.5, +62.7 | +52.3 |
| AIS Grade E conversion | 2 patients | 0 patients |
| Pain reduction (VAS score) | –44.3 (1200 mg), –23.7 (2400 mg) | –20.9 |
KOL Views
“This is a groundbreaking approach to spinal cord injury. ALMB-0166’s mechanism is unique, and early clinical signals show functional improvements we rarely observe in this time frame.” – Expert Opinion.
“Blocking secondary damage via astrocyte connexin channels is a novel therapeutic angle. The encouraging safety and efficacy data warrant further development.” – Expert Opinion.
Conclusion
The Phase I/II study of ALMB-0166 demonstrates a favorable safety profile and early signs of neurological benefit in patients with acute cervical SCI. As the first agent of its kind targeting astrocyte connexin-43 hemichannels, ALMB-0166 represents a promising neuroprotective strategy with the potential to fill a long-standing gap in acute SCI treatment. Further clinical development and expansion into larger confirmatory studies are warranted.
Article in PDF
Jul 09, 2025
At the EAN 2025 Congress, investigators from Peking Union Medical College Hospital and CSPC Pharmaceutical Group presented first-in-human clinical data from the Phase I/II randomized, placebo-controlled trial evaluating ALMB-0166 in patients with acute cervical spinal cord injury (SCI). ALMB-0166 is a first-in-class humanized monoclonal antibody that blocks connexin-43 hemichannels in astrocytes, an emerging target thought to mitigate secondary injury and promote neuroregeneration after SCI.
EAN 2025 Coverage: Safety and Efficacy of Almb-0166 in Patients With Acute Spine Cord Injury (SCI): A Randomized, Phase I/II Study
The study enrolled 24 adult patients with acute traumatic SCI (levels C3–C7), American Spinal Injury Association (ASIA) Impairment Scale (AIS) Grades B or C, within 72 hours of injury. Participants were randomized to receive a single IV dose of ALMB-0166 (200–4800 mg) or placebo, alongside best supportive care. The primary objective was to assess safety and tolerability, with motor, sensory, and functional outcomes evaluated over 56 days.
Dosing Arms
Safety Profile
ALMB-0166 was well tolerated at all doses, with fewer high-grade AEs than placebo.
| Safety Endpoint | ALMB-0166 (n = 17) | Placebo (n = 7) |
| Any TEAE | 94.1% | 100% |
| ≥Grade 3 TEAEs | 17.6% | 42.9% |
| Common Grade ≥3 Events | Hypokalemia, pulmonary inflammation, respiratory failure, deep venous thrombosis | Hypokalemia, hyponatremia |
Preliminary Efficacy Signals at Day 56
Patients receiving ALMB-0166 showed clinically meaningful improvements in motor, sensory, and functional scores versus placebo. These early signs of neurologic improvement and pain reduction support the therapeutic rationale of targeting astrocytic connexin-43 in the acute injury phase.
| Endpoint | ALMB-0166 | Placebo |
| Motor score change (2400 mg) | +66.0 | +45.6 |
| Sensory score change (600–1200 mg) | +77.5, +62.7 | +52.3 |
| AIS Grade E conversion | 2 patients | 0 patients |
| Pain reduction (VAS score) | –44.3 (1200 mg), –23.7 (2400 mg) | –20.9 |
KOL Views
“This is a groundbreaking approach to spinal cord injury. ALMB-0166’s mechanism is unique, and early clinical signals show functional improvements we rarely observe in this time frame.” – Expert Opinion.
“Blocking secondary damage via astrocyte connexin channels is a novel therapeutic angle. The encouraging safety and efficacy data warrant further development.” – Expert Opinion.
Conclusion
The Phase I/II study of ALMB-0166 demonstrates a favorable safety profile and early signs of neurological benefit in patients with acute cervical SCI. As the first agent of its kind targeting astrocyte connexin-43 hemichannels, ALMB-0166 represents a promising neuroprotective strategy with the potential to fill a long-standing gap in acute SCI treatment. Further clinical development and expansion into larger confirmatory studies are warranted.
