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Linda Zhong

NeuroAiD combined with rehabilitation has shown additive and sustained benefits on post-stroke recovery over 2 years after an initial 3-month treatment following stroke onset

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  • More subjects on NeuroAiD™ improved to functional independence compared to placebo among subjects receiving rehabilitation up to 3 months after an acute ischemic stroke.
  • The larger treatment effect of NeuroAiD™ was sustained over 2 years which supports the hypothesis that NeuroAiD™ and rehabilitation might have additive and sustained benefits on neuro-repair processes after stroke.
  • The results were consistent at various time points and seen on several indices, i.e. modified Rankin Scale (mRS) and Barthel Index.

Singapore, 28 September 2018 – Moleac is pleased to announce the release of the results of an analysis showing the additional effect on post-stroke recovery of NeuroAiD™ combined to rehabilitation, published online in the journal Cerebrovascular Diseases1. Positive results at 3 months of the combination of NeuroAiD™ and rehabilitation had been communicated by Prof. Christopher Chen (CHIMES-E co-principal investigator) during the European Stroke Organization Conference (ESOC 2018) in Gothenburg, May 16. These new results recently published provide convincing data showing that this additive and sustained effect of NeuroAiD™ is maintained over two years in patients having received persistent rehabilitation up to 3 months. They confirm persisting long-term benefits of NeuroAiD™ on patients’ recovery after an ischemic stroke already demonstrated on 880 patients in the CHIMES-Extension study².

This analysis conducted in 380 patients having received persistent rehabilitation up to 3 months shows that adding NeuroAiD™ increases significantly the odds of improving functional recovery and independence at 3 months and beyond after an acute ischemic stroke, compared to placebo in double-blind with well-balanced groups at baseline. The odds of recovery were increased by more than twice at 6 months and 1 year, with a success rate maintained over 2 years. This confirms the sustained additive effect of NeuroAiD™ to the one of rehabilitation supporting the brain neuro-repair processes spontaneously initiated after the occurrence of any brain lesion All these results were consistent at various time points and seen on 3 indices, i.e. mRS ordinal, mRS dichotomy 0-1, and Barthel Index.

“Stroke recovery is a multi-layered process and is complex. Hence, it is likely that a multi-modal approach may be more effective in achieving better patient outcomes, by regulating more than one endogenous neurobiological process to address the complexity of the stroke recovery process,” said Prof. Nijasri C Suwanwela, director of Chulalongkorn Comprehensive Stroke Center, Chulalongkorn University and co-investigator of the CHIMES-E study². “In this new analysis, we were able to show that NeuroAiD™ combined with rehabilitation achieved better outcome both on functional recovery and independence in activities of daily living than rehabilitation alone,” she added. “There is a need for more data on the effect of combining rehabilitation programs with post-stroke treatments,” she concluded.

These results confirm the hypothesis raised by the CHIMES-E investigators: NeuroAiD™ combined to rehabilitation have a sustained additive effect compared to rehabilitation alone for improving functional outcomes after stroke 1. Since most post -stroke patients already undergo rehabilitation, combining a medical intervention that facilitates adaptive neuroplasticity with rehabilitation may be a logical and simple strategy for such multi-modal therapy, hence suggesting to extend NeuroAiD™ treatment duration beyond the 3 initial months, while recovery process is still in progress.

About CHIMES Society

The CHIMES Society is an international academic industry collaboration with the objective to establish new stroke treatments. It is a Singaporean non-profit society founded by a group of experts in stroke and South-East Asian stroke clinicians interested to implement a research project: the NeuroAiD™ Efficacy on stroke recovery trial (CHIMES trial).

The CHIMES-E Study was supported by the CHIMES society and grants were received by CHLC from the National Medical Research Council in Singapore (NMRC) which supports the implementation of CHIMES trial in Singapore.

About Moleac

To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative compound NeuroAiD™ reaches patients in more than 30 countries.

  1. Suwanwela NC, et al. Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies. Cerebrovasc Dis. 2018;5;46(1-2):82-88. doi: 10.1159/000492625
  2. Venketasubramanian N, et al. CHInese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy. Cerebrovasc Dis. 2015;44 39:309–318. doi: 10.1159/000382082

For more information:

Yeonhee Pee
Email: yeonhee.pee@moleac.com
Phone: +65-62113710

Moleac Announces US FDA Approval of IND Application for Phase 1 Study of MLC1501 Programme in Post-Stroke Recovery

By | News

SINGAPORE, March 5, 2018 /PRNewswire/ — Moleac, a biopharmaceutical company focused on research and development of new medicines for central nervous system (CNS) diseases and injuries, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of MLC1501, as first step of a clinical programme in post-stroke recovery treatment. Approval of this IND enables Moleac to initiate a safety study of MLC1501 in normal subjects as part of the overall clinical development plan for demonstrating that MLC1501 improves functional independence and recovery of motor, speech, cognition and other neurological dysfunctions in post-acute ischemic stroke (AIS) survivors having not recovered after acute treatments (thrombolysis, thrombectomy) or having not received them. Beyond the acute phase, there are no available treatments, other than rehabilitation measures, to relieve the disabilities suffered by stroke survivors. Proving clinical safety and efficacy of MLC1501 on long-term functional and neurological recovery in patients suffering from AIS will fill a therapeutic gap and help reduce the overall burden of stroke.

This is a clear milestone for Moleac to commence development of MLC1501 an agent that has proven successful in Asia for use in the USA as a new treatment for post-stroke recovery, an area where we need more agents to reduce the devastating burden of stroke for patients and their families,” said professor Lou Caplan of Beth Israel Deaconess Medical Center and Harvard University. “We already have learned much about the properties of the parent compound, NeuroAiD. This information will guide the clinical development of MLC 1501, and trials of its use in the USA.” Prof Caplan added.

David Picard, CEO of Moleac, added, “The US FDA’s clearance of this IND is validating our collaborative and determined approach to move into registration trials for post-stroke recovery. We are confident and eager that this Phase I study will confirm the safety of MLC1501 for starting as early as possible Phase II with international stroke centers and patients. We are grateful to all our colleagues, our partners in academia and our corporate partners without whom this step forward would not have been possible.”

About Stroke

Stroke is considered among the world’s most debilitating diseases with high mortality rate and afflicts over 17 million people worldwide each year, of which more than 80% of cases are ischemic stroke. Stroke not only endangers the lives of victims but also burdens the families of the stroke survivors with significant caretaking and financial expenses.  Despite the use of revascularization treatments in AIS, a huge number of stroke survivors will suffer from disabilities causing a substantial impact on their day-to-day life and functioning, and a heavy financial burden on society.

About MLC 1501

MLC150is a further developed formulation consisting of four of the original nine herbs that are present in two parent formulations, MLC601 and MLC901 (NeuroAiD™). Pharmacological studies have demonstrated equivalent neuroprotective and neurorestorative properties of MLC1501 in nonclinical animal and cellular models of focal ischemia. Clinical trials of MLC601/MLC901 and systematic reviews of those trials showed benefit in improving functional and neurological recovery, in patients having functional impairment after an acute ischemic stroke.

About Moleac

Moleac is a biopharmaceutical company dedicated in finding, developing and commercializing worldwide new medicines for the unmet medical needs of patients suffering of central nervous system (CNS) diseases and injuries, such as stroke, dementia and traumatic brain injuries. To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative natural formulation NeuroAiD™ reaches patients in more than 30 countries where it is regulated.

Contact

Clément Dif, Business Development & Marketing Department
Emailclement.dif@moleac.com
Phone: +65-62113710
Web: www.moleac.com

NeuroAiD at ASEAN Neurological Association

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Moleac will attend the 12th Biennial Convention of ASEAN Neurological Association (ASNA) & 39th Annual Convention of Philippine Neurological Association (PNA), in Manila, Philippines from 21 to 24 November.

Prof. N Venketasubramanian (Ramani) from Singapore, one of the principal investigators of NeuroAiD’s landmark study, CHIMES-E, will present the following posters:

  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-Stroke Recovery – The CHIMES Study.
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study.
  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E Study.

In addition, Moleac and E*Chimes (distributor of NeuroAiD in the Philippines) will host a Twilight symposium with renowned speaker Prof. Simeon Marasigan from the Philippines to introduce the NEURITES study on 22nd November, 17:00 – 19:00:

  • NEURoaid II (MLC901) Assessment in Cognitivitely Impaired Not Demented Subjects: A Pilot Double Blind, Placebo Controlled Randomized Trial in Efficacy and Safety (NEURITES) Study (Preliminary Report).

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD at Asia Pacific Stroke Conference

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Renowned clinicians and researchers will present abstracts from the latest studies conducted on NeuroAiD, including the principal investigators of NeuroAiD’s landmark study, CHIMES-E, demonstrating the long-term benefits of a 3-month course in achieving functional independence:

  • Prof. Christopher Chen from Singapore:

Abstract: Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E Study.

  • Prof. N Venketasubramanian (Ramani) from Singapore

Abstract: Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study.

  • Prof. Nijasri Suwanwela from Singapore

Abstract: Synergistic Effect of Combining MLC601 and Rehabilitation on Post-Stroke Recovery – The CHIMES Study.

Refer to the APSC program for more details – 26th to 28th October, Nanjing, China.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

Moleac awarded prize from Creative France – recognising the success of French entrepreneurs in Singapore

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“Entrepreneur” is a French invention for risk takers committed to innovate, and Moleac is a complete illustration of successful entrepreneurial biopharmaceutical company in Singapore.

A quote from his Excellency, Ambassador Benjamin Dubertret, French Ambassador in Singapore

“The “Creative Next” contest aims at showcasing French ingenuity and identifying inspirational French entrepreneurs or SMEs that have demonstrated creativity and innovation in their business. Thanks to its innovative therapeutic solutions to neurological diseases, finalist company Moleac perfectly embodies the essence of French “creativité”: an exceptional ability to innovate paired with scientific excellence and talent.”

In 2016, Moleac celebrated the 10 years’ anniversary of its flagship product, NeuroAiD.

NeuroAiD was initially launched in Singapore in 2006 and rapidly expended to over 35 countries worldwide. This innovative product fulfills a major therapeutic gap for stroke victims in their journey to recover their functional independence. Today, NeuroAiD is in the running to become Singapore’s first home-grown drug.

The idea was born in France and initially funded from Europe. We saw the opportunity to bridge the gap between Traditional Chinese Medicine (TCM) and Western medicine, two paths which usually don’t cross at all. The decision to locate the company in Singapore was based on the understanding of both Eastern and Western medicine here in Singapore, which is essential for NeuroAiD’s development. We also wanted to ensure our research and data could stand the scrutiny of clinicians internationally. In the past 10 years, NeuroAiD has undergone clinical trials in Singapore and internationally, demonstrating its efficacy in boosting recovery of neurological functions after a stroke. NeuroAiD has reached 20,000 patients last year and we are currently working towards obtaining full-fledged drug approval in the United States and Europe.

We are honored to receive this award from Creative France which represents wider recognition of our commitment to innovate and bring therapeutic solutions to thousands of stroke victims worldwide.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.