Singapore, June 6, 2022, Moleac is pleased to announce the release of the results of the SATURN study¹ published online in the Journal of Spinal Cord Medicine.

• SATURN study aimed at assessing the safety and effects of a 6-month course of NeuroAiD (MLC601/MLC901) to augment functional and motor recovery after severe spinal cord injury (SCI).
• NeuroAiD was safe as add-on treatment in patients with severe SCI.
• One third of patients improved on ASIA Impairment Scale (AIS) grading with corresponding motor recovery at month 6.

Spinal cord injury (SCI) carries debilitating consequences with severe neurological and functional deficits, deteriorating the quality of life for survivors and their relatives. To date, there is no way to reverse spinal cord damage, and new treatments are always sought, including prostheses, devices and medications, to improve motor function and function recovery in SCI.

NeuroAiD has well established neuroprotective and neurorepair properties that enhance neurological recovery on top of rehabilitation in stroke and traumatic brain injury. It could represent a new therapeutic approach for SCI patients.

SATURN (Spinal cord injury Assessing Tolerability and Use of combined Rehabilitation and NeuroAiD) study was designed to evaluate the safety and potential role of NeuroAiD in subjects suffering from severe SCI. This pilot study included 30 subjects with American Spinal Injury Association (ASIA) Impairment Scale (AIS) grades A and B, who received a 6-month course of NeuroAiD on top of standard care and rehabilitation.

The key endpoints were the safety profile by measuring the occurrence of adverse events (AEs) during the 6-month course of NeuroAiD and the improvements in the AIS grade and motor score at month 6.

Key findings:

• A total of 14 AEs were reported by 10 patients, none being deemed definitely, likely or possibly related to NeuroAiD.
• 33% of patients improved their AIS score at month 6 from baseline, with improvement in 25% and 50% of patients in the AIS A and AIS B groups, respectively. One patient has even achieved complete recovery (grade E).
• The Asia total motor score improved over time from 17.1 at baseline to 49.9 at month 6.

Of note, the investigators pointed out that the improvement rates during the 6-month course of NeuroAiD appear to be higher than the previously reported spontaneous recovery rates of approximately 10% from grade A to grade B and 10 % at grade C, 80% of patients remaining at grade A.

“Any improvement in AIS grading is clinically important for SCI patients,” said Prof. Ramesh Kumar, neurosurgeon at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. “The rates of improvement we saw at 6 months in our study with NeuroAiD in this severe SCI sample with excellent safety, are very encouraging to use and to develop it as a complementary therapeutic option.”

NeuroAiD shows a favourable safety profile and promising benefits as an add-on therapy to patients suffering from severe spinal cord injuries.

ACCESS THE ARTICLE HERE

NeuroAiD™ and NurAiD™ are trademarks of Moleac. MLC601 (NeuroAiD™) and MLC901 (NeuroAiD™II/NurAiD™II) are two different proprietary formulae which have been shown to be equivalent in pharmacology and are referred as “NeuroAiD” in this document. 

1. Ramesh Kumar et al. Spinal cord injury – assessing tolerability and use of combined rehabilitation and NeuroAiD (SATURN) study – primary results of an exploratory study. The Journal of Spinal Cord Medicine. May 2022, DOI: 10.1080/10790268.2022.2067972.

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