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Moleac Pte Ltd wins SBR National Business Award for Pharmaceuticals

By News

SINGAPORE, MAY 2021

Moleac, a biopharmaceutical company based in Singapore, wins SBR National Business Award for Pharmaceuticals.

Moleac is dedicated in finding, developing, and commercializing new medicines for the unmet medical needs of patients suffering from central nervous system diseases and injuries. From stroke, traumatic brain injury (TBI) and dementia, the company’s main goal is to help people with disabilities after brain injuries or neurodegenerative diseases—as well as their families—reconnect with their lives.

Stroke is considered one of the most debilitating diseases, afflicting over 17 million people each year. Stroke not only endangers the lives of stroke survivors, but also burdens families with significant caretaking and financial expenses. Despite the use of revascularization treatments in AIS, a huge number of stroke survivors will suffer from disabilities that will cause a substantial impact on their day-to-day lives.

Moleac has pioneered a new drug development approach that looks at sources of innovation from natural medicine, thus considerably shortening drug development cycle time and investment to bring medicine to post-stroke recovery patients.

The company scientifically selected natural compounds and formulations from traditional medicine and developed them according to international standards. This is one of the reasons why Moleac chose to be based in Singapore, which represents a hub within the Asia-Pacific region where traditional medicines originated and has close links with the rest of the world.

Thus, their first marketed product, NeuroAiD for post-acute ischemic stroke (AIS) has experienced exceptional commercial development, reaching 30,000 patients in more than 35 countries each year. Close collaboration with academia has generated a large body of scientific and clinical data supporting the design of future trials for developing a botanical drug.

Building on this success, the company expanded their worldwide presence from Singapore and developed a new herbal formulation (MLC1501) in post-stroke recovery. An Investigational New Drug application (IND) has been opened by US-Food and Drug Administration (USFDA), which allowed them to conduct two safety studies of MLC1501 in healthy volunteers (Phase 1). With an overall clinical development plan that hypothesizes MLC1501’s effectiveness in improving functional and motor independence and recovery of neurological impairments in post-AIS survivors having not received or not recovered after acute treatments (thrombolysis, thrombectomy).

“MLC1501 is being developed as a botanical drug treatment to improve functional independence and recovery of motor, speech, cognition and other neurological dysfunctions resulting from neurological conditions such as stroke, traumatic brain injury (TBI). This would mean an improvement of day-to-day functioning of patients who have experienced a neurological condition. Emily Lim, Associate Vice President, Clinical Operations

In 2020, US-FDA has encouraged Moleac to move directly to a pivotal study, representing a noticeable acceleration of the overall program.

Prof Lou Caplan of Beth Israel Deaconess Medical Center and Harvard University said: “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.”

These patients are those who will be recruited in the next development phase, prepared in 2020 and which should start this year, to demonstrate the efficacy and safety of MLC1501 in post-stroke recovery. A second IND was recently approved for MLC1501 in TBI.

 

Contact

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

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

By News

SINGAPORE, APRIL 21

Moleac, a biopharmaceutical company based in Singapore, announced the approval by the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application for MLC1501 in traumatic brain injury (TBI).

Moleac is dedicated in finding, developing and commercialising new medicines for the unmet medical needs of patients suffering from central nervous system diseases and injuries, such as stroke, TBI, and dementia.

The approval of this IND comes 3 years after the opening of the first IND by the U.S. FDA for MLC1501 in Post-Stroke Recovery, allowing Moleac to conduct a phase 1 study (safety study) in healthy volunteers which has been successfully completed.

This approval represents another milestone for Moleac, supporting our ambition to provide best in class therapeutic options to patients in need. We are confident that MLC1501 will go through the several steps to be registered and marketed, making it available to the largest number of stroke and TBI victims in the near future. We would like to thank our colleagues and partners for their support, as this major step forward would have not been possible without their efforts and determination.David Picard, CEO of Moleac.

The road is now paved to prove the safety profile and the efficacy of MLC1501 on functional and neurological recovery in patients suffering from TBI. By succeeding with its drug development, Moleac would make a breakthrough in current treatment options to support patients with their recovery and reducing the overall burden of TBI.

Direct link to full press release: Click here.

 

 

About TBI  

TBI is defined as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury. It is one of the leading causes of disability worldwide and is affecting about 70 million people each year. A large number of TBI survivors suffers from disabilities causing a substantial impact on their day-to-day life and functioning, and represents a heavy financial burden on society.

About MLC1501

MLC1501 is a further developed formulation consisting of four of the original nine herbs that are present in two parent formulations, MLC601 and MLC901 (NeuroAiD™). Clinical trials of MLC601/MLC901 showed benefit in improving functional and neurological recovery in patients having impairments after a Stroke or a TBI. In 2018, the U.S. FDA has approved an IND for MLC1501 in post-stroke recovery, the phase 1 was completed in 2020.

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
Email: clement.dif@moleac.com
Phone: +65-62113710
Web: www.moleac.com

ESOC 2020: Abstracts on NeuroAiD

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In November 2020, ESO-WSO provided scientific updates to Health Care Practitioners. During this conference, 4 abstracts on NeuroAiD’s safety and efficacy in post-stroke recovery are presented by international speakers.

Embracing World Stroke Day 2020

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World Stroke Day 2020

Stroke remains one of the main cause for disability worldwide. Moleac remains committed to helping patients Reconnect with their loved ones. We always place patients at the center of everything we do, and their journey towards full recovery is what reminds us of our main purpose as a healthcare company.

Highlights from Asia Pacific Stroke Organization (APSC) and World Congress of Neurology (WCN) Scientific Symposia

By News

Two scientific symposia were conducted on the 2nd October 2019 and 29th October 2019. Multiple international faculty members shared their perspectives and experiences of using NeuroAiDTM in stroke management from different clinical settings.

  • Professor Jose C. Navarro from University Santo Tomas Hospital, Philippines, moderated the scientific sessions during APSC
  • Professor Christopher Chen from the National University of Singapore, presented the effects of NeuroAiDTM on long-term functional outcomes after stroke
  • Professor Nijasri C. Suwanwela from Chulalongkorn University Thailand, presented the effects of combination treatment with NeuroAiDTM and rehabilitation
  • Professor Anita Arsovska from University Clinical of Neurology, University Ss Cyril and Methodius from North Macedonia, presented sustaining post-stroke recovery with NeuroAiDTM
  • Professor Ihsan K. Al-Shimmery from Iraq, presented Bridging Stroke Updates to Clinical Experience
  • Professor Mitchel Lazdunski from CNRS France, presented NeuroAiDTM’s multimodal mode of action

Professor Chen commented that “it is spectacular that even a 3-month treatment can (translate to) such long-term benefi­t, and highlighted that “in patients who do not have such a good prognosis, NeuroAiDTM enhances recovery and more patients gradually improved to full independence (mRS 0 – 1) and they stayed there”. After presenting a series of interventions that are useful to encourage neuroplasticity, Professor Nijasri highlighted that “maybe we need a combination of the treatments, not only physiotherapy but maybe some other ways to enhance recovery”. Both Professor Anita and Professor Ihsan acknowledged the efficacy of NeuroAiD among the majority of their clinical settings, with well-tolerated safety profile. Using the results of a recent study, he presented that NeuroAiD™ is able to regulate neuroinflammation, which is essential to initiate and maintain the process of neuro-repair after brain injuries.

 

 

CHIMES-E Study

 

CHIMES-E, NeuroAiD’s landmark study, assessed recovery for up to 2 years following a stroke. More patients in the treatment group achieved functional independence (mRS 0-1) with significant results from month 6 to 18 compared to the placebo group. Moreover, combining NeuroAiD and rehabilitation doubled the odds of achieving functional independence as early as month-3, with the effect persisting over 2 years as compared to patients who underwent rehabilitation alone.

 

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.

Highlights from European Stroke Organisation Conference (ESOC) Scientific Symposium

By News

June 2019

A scientific symposium was held on the 24th May 2019, which aimed to share the advance of stroke rehabilitation and the role of NeuroAiD in post-stroke recovery.

Clinicians from Southeast Asia, Europe, and Middle-East attended the symposium. International faculties presented their perspectives on patients’ journey through stroke recovery and the critical role of both rehabilitation and NeuroAiD to achieve functional independence.

  • Professor Christopher Chen from the National University of Singapore provided an overall perspective and moderated the entire scientific session
  • Professor Pamela Duncan from Wake Forest University of the United States of America, presented stroke recovery therapeutics and rehabilitation
  • Professor NV Ramani from Raffles Hospital Singapore, presented the effects of NeuroAiD on long-term functional outcomes after stroke
  • Professor Suwanwela NC from Chulalongkorn University Thailand, presented the effects of combination treatment with NeuroAiD and rehabilitation
  • Professor M Lazdunski from CNRS France, presented NeuroAiD’s multimodal mode of action

Professor Duncan emphasized that “we are transforming acute care”. Indeed, the mortality rate of stroke patients in the United States is decreasing, however, “we are not managing the disability” among these patients. In other words, “stroke patients are living longer, with higher chance of survival, but they are not given with optimal recovery”. It is important to note that in “rehab and recovery, there is reorganization of the brain, neurogenesis, regulation of growth factors, and all of these processes take time. Therefore the “primary endpoint of clinical trials assessing recovery should be 6 months to 1 year”, she added.

 

CHIMES-E Study

CHIMES-E, NeuroAiD’s landmark study, assessed recovery for up to 2 years following a stroke. More patients in the treatment group achieved functional independence (mRS 0-1) with significant results from month 6 to 18 compared to the placebo group. Moreover, combining NeuroAiD and rehabilitation doubled the odds of achieving functional independence as early as month-3, with effect persisting over 2 years as compared to patients who underwent rehabilitation alone.

 

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 holds two educational symposia on the management of Traumatic Brain Injury

By News

March 2019

Moleac organized two symposia in Dubai and Bangkok on new approaches for Traumatic Brain Injury (TBI) recovery.

In these symposia, the speakers emphasized on the global burden of TBI, the lack of treatment options for patients, and the scientific and clinical background supporting the role of NeuroAiD to help patients who have suffered from a TBI and other brain injuries.

Clinicians from Southeast Asia, Europe, and Middle-East attended the sessions presented by International faculties:

Professor Valery Feigin (MD, MSc, PhD, FAAN), director from the AUT National Institute for Stroke and Applied Neuroscience from New Zealand, presented the BRAINS Study assessing the safety and efficacy of NeuroAiD in TBI patients.

  • Professor Mihai Berteanu (MD, PhD), senior consultant from Elias University Hospital, Romania, discussed about the consistency of NeuroAiD’s neurorestorative properties across brain injuries.
  • Associate Professor Ihsan K. Al-Shimmery from Hawler Medical University in Iraq, presented the effect of combining rehabilitation with NeuroAiD.
  • Lee Khean Hin from Gleneagles Hospital Singapore, shared his clinical experience of using NeuroAiD in several types of brain injuries.
  • Associate Professor Ramesh Kumar (MD, MRCS, FRCS) from the National University of Malaysia (UKM), one of the primary investigators for SATURN and NeST registry in Malaysia, presented the preliminary findings for these two studies.

 

The BRAINS Study

The BRAINS Study was conducted in New Zealand and published in the European Journal of Neurology in April 2018. It investigated the clinical relevance of NeuroAiD for mild-to-moderate TBI patients who suffered from persistent cognitive deficits. Complex Attention (ability to multi-task) and Executive Functioning (planning and decision making) are the most commonly affected cognitive domains following a TBI. Both cognitive domains were significantly improved after a 6-month treatment of NeuroAiD versus placebo and over the 9-month follow-up period, with a good safety profile.

In addition to the BRAINS study, ongoing research on the potential role of NeuroAiD in Spinal Cord Injury (SCI) and case reports of Intra Cranial Hemorrhage (ICH) and TBI confirm the safety profile of NeuroAiD and its promising role in improving recovery after brain injuries.

 

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 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

By News
  • 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