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.