Monthly Archives

November 2016

Prognostic Factors and Pattern of Long-Term Recovery with MLC601 (NeuroAiD™) in the Chinese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study

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Cerebrovasc Dis 2017; 43:36-42

Published by S. Karger AG, Basel

This analysis from the CHIMES-E study shows that subjects with prognostic factors of poorer outcome get a higher benefit on post-stroke functional recovery with a 3-month course of NeuroAiD compared to placebo, with statistically significant differences seen as early as 3 months and persisting over the long term. At 12 months NeuroAiD almost doubles the chances of achieving functional independence. These results indicate that selection of subjects with poorer prognosis, particularly those with more severe NIHSS score and longer OTT* delay, as well as a longer follow-up period and treatment duration can maximize the recovery potential of subjects included in post-acute stroke clinical trials.

Authors: Narayanaswamy Venketasubramanian, Chun Fan Lee, Sherry H. Young, San San Tay, Thirugnanam Umapathi, Annabelle Y. Lao, Herminigildo H. Gan, Alejandro C. Baroque II, Jose C. Navarro, Hui Meng Chang, Joel M. Advincula, Sombat Muengtaweepongsa, Bernard P.L. Chan, Carlos L. Chua, Nirmala Wijekoon, H. Asita de Silva, John Harold B. Hiyadan, Nijasri C. Suwanwela, K.S. Lawrence Wong, Niphon Poungvarin, Gaik Bee Eow, Christopher L.H. Chen for the CHIMES-E Study Investigators

Keywords: Acute stroke, Stroke recovery, MLC601, NeuroAiD, Prognosis, Clinical trial, Long-term outcome

Abstract:

Background: The Chinese Medicine NeuroAiD Efficacy on Stroke recovery – Extension (CHIMES-E) study is among the few acute stroke trials with long-term outcome data. We aimed to evaluate the recovery pattern and the influence of prognostic factors on treatment effect of MLC601 over 2 years.

Methods: The CHIMES-E study evaluated the 2 years outcome of subjects aged ≥ 18 years with acute ischemic stroke, National Institutes of Health Stroke Scale (NIHSS) score 6–14, pre-stroke modified Rankin Scale (mRS) score ≤ 1 included in a multicenter, randomized, double-blind, placebo-controlled trial of MLC601 for 3 months. Standard stroke care and rehabilitation were allowed during follow-up with mRS score being assessed in-person at month (M) 3 and by telephone at M1, M6, M12, M18 and M24.

Results: Data from 880 subjects were analyzed. There was no difference in baseline characteristics between treatment groups. The proportion of subjects with mRS score 0–1 increased over time in favor of MLC601 most notably from M3 to M6, thereafter remaining stable up to M24, while the proportion deteriorating to mRS score ≥ 2 remained low at all time points. Older age (p < 0.01), female sex (p = 0.06), higher baseline NIHSS score (p < 0.01) and longer onset to treatment time (OTT; p< 0.01) were found to be predictors of poorer outcome at M3. Greater treatment effect, with more subjects improving on MLC601 than placebo, was seen among subjects with 2 or more prognostic factors (OR 1.65 at M3, 1.78 at M6, 1.90 at M12, 1.65 at M18, 1.39 at M24), especially in subjects with more severe stroke or longer OTT.

Conclusions: The sustained benefits of MLC601 over 2 years were due to more subjects improving to functional independence at M6 and beyond compared to placebo. Selection of subjects with poorer prognosis, particularly those with more severe NIHSS score and longer OTT delay, as well as a long follow-up period, may improve the power of future trials investigating the treatment effect of neuroprotective or neurorestorative therapies.

 

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Moleac’s Flagship Product NeuroAiD Named Asia Pacific Neurological Disorders New Product Innovation of the Year At the Frost & Sullivan Best Practices Awards

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NeuroAiDTM has been named New Product Innovation of the Year by Frost & Sullivan. This award recognizes healthcare products that are bringing innovative solutions for neurological disorders by pushing the boundaries of the usual practices. This award also acknowledges Moleac for its effort and continuous investment in NeuroAiDTM‘s Research and Development. Mr. David Picard, CEO of Moleac, received the 2016 Frost & Sullivan Asia Pacific New Product Innovation Award at the awards ceremony held this evening at Conrad Singapore. The ceremony was attended by leaders from the healthcare sector.

Frost & Sullivan followed a rigorous measurement-based methodology to select NeuroAiDTM as the recipient. Its independent panel of judges included senior members across various offices at Frost & Sullivan. The judging panel looked at market performance indicators, including revenue growth, market share, availabilities, geographical expansion and marketing strategies. The full  Frost & Sullivan Award Research Report for Moleac is available here.

Dr. M. Shaillender, Industry Analyst, Healthcare Practice – Asia Pacific at Frost & Sullivan, said, “Stroke rehabilitation is an underserved segment in the pharmaceutical industry. Moleac aims to address the existing gaps in stroke therapy with an unconventional approach similar to reverse innovation.’ NeuroAiDTM is a product originating from Traditional Chinese Medicine that has demonstrated excellent attributes in post-stroke recovery, however, without any scientific and clinical evidence. Moleac’s team was instrumental in identifying and decoding the underlying neuromodulatory properties to translate it into a therapeutic drug supported by clinical evidence for neurological disorders.”

He further adds, “As one of the first therapies of its kind, NeuroAiDTM is today accepted as an innovative treatment for post-stroke recovery. It is approved and marketed in over 35 countries as a supplement for stroke rehabilitation. Executing well in its vision, Moleac is on a trajectory to expand the horizons of NeuroAiDTM into a mainstream therapeutic drug for neurological disorders.”

David Picard, CEO of Moleac, said, “I am delighted to receive this award from Frost & Sullivan while we are celebrating the 10 years’ anniversary of NeuroAiDTM. Having launched NeuroAiDTM in 2006, we have been focusing our efforts on making NeuroAiDTM available to stroke sufferers around the world. NeuroAiDTM is the first medicine to support stroke recovery, and this is a huge unserved need for millions of suffers. In 2016, over 20,000 patients benefited from NeuroAiDTM worldwide and we aim at making NeuroAiDTM available to more patients in the coming years.”

He continued to add, “I would like to thank all those who have contributed to NeuroAiDTM‘s development over the past 10 years. This includes our academic partners, who have shown interest in our approach enabling its clinical development, our investors who have trusted us, and of course my colleagues who have made this venture a success. Without their support, NeuroAiDTM would not be where it is today. We keep investing in Research with several on-going clinical studies to provide first-class evidences of NeuroAiDTM‘s benefits in other unserved neurological disorders.”

NeuroAiDTM is a natural medicine originating from Traditional Chinese Medicine. In addition to its excellent safety profile, clinical trials have shown that patients taking NeuroAiDTM for 3 months have higher chances to reach functional recovery, with prolonged benefits over the long-term as published in Cerebrovascular Diseases (April 2015). About 3,000 subjects have been included in clinical trials and Moleac is currently supporting additional international clinical trials to demonstrate the potential of NeuroAiDTM in other neurological disorders.

About Moleac: Moleac is a Singapore-based biopharmaceutical company that dedicates itself to finding and developing new medicines for the unmet needs of patients worldwide.

About NeuroAiDTM: NeuroAiDTM is a post-stroke recovery treatment to help stroke survivors achieve a faster and better recovery. Moleac also markets NeuroAiD II, a simplified formula. Both products are shown to be equivalent in pharmacology. It currently reaches out to patients in over 35 countries.