A group of Indian researchers have developed a compound called “6BIO” that can provide a better method to treat Autism Spectrum Disorder (ASD). They have determined the potency of the compound in a pre-clinical mice model. This is the first compound that has been proved in pre-clinical evaluation to have the potential for improving daily activities like learning and recollecting new tasks in patients with ASD/ Intellectual disability (ID).
Autism Spectrum Disorder (ASD) is one of the major issues causing a tremendous burden to our society. Yet, it does not have an appropriate pharmacological or genetic method to treat ASD/ID. Current therapeutics to treat ASD aims to alleviate symptoms such as epileptic seizures or sleep issues but not to treat the multiple problems of ASD/ID. A major challenge in finding better therapeutics to treat ASD is the potency of the drug to help the patients to perform their daily activities with efficiency close to that of a healthy person. Achieving this is particularly difficult after a certain age, especially from the mid-childhood stages.
In the present work, Vijaya Verma and other authors from Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), an autonomous research institute of the Department of Science & Technology (DST), Govt. of India, have demonstrated the potential of 6BIO, to treat ASD/Intellectual disability (ID) in a pre-clinical mouse model called Syngap1+/-. Using behaviour and electrophysiology techniques, the team of scientists have shown in a research published in the Experimental Brain Research that the administration of 6BIO restores the neuronal function, learning and memory, and reduces epileptic seizures in Syngap1+/- mice.
The authors of this study Vijaya Verma, M. J. Vijay Kumar, Kavita Sharma, Sridhar Rajaram, Ravi Muddashetty, Ravi Manjithaya, Thomas Behnisch and James P. Clement, identified 6BIO synthesised in JNCASR and found that it restores neuronal function, learning and memory, sociability and reduces epileptic seizures. The other novelty of this study is that 6BIO restored the neural functions not only when administered during development (equivalent of baby (1-2 years) and childhood stages (3-6 years)) but also after mid-childhood (7-11 years) when most of the brain regions are considered to have formed properly.
Previous studies have attributed disruption in optimal brain development, mainly neuronal connections, during the early stage of development (i.e., babies/childhood) as one of the causes of ASD/ID. Due to the altered brain development, information processing becomes aberrant and understanding simple tasks becomes exceptionally challenging for patients with ASD/ID. Using electrophysiology, which helps understand how neurons communicate, and behaviour experiments, which indicates the overall brain function, the JNCASR team has shown that 6BIO can restore the information processing in the pre-clinical mouse model. Thus, 6BIO has a strong potential for therapeutics to treat ASD/ID. All the behaviour and electrophysiology work was performed in Dr James Clement’s lab at JNCASR.
Patients with ASD still struggle to perform everyday activities without assistance from others as they are unable to learn and recollect new tasks. Data from the current study indicate that 6BIO can help children with ASD learn and recall, be social, and alleviate other symptoms such as seizures or sleep issues. Thus, the compound, 6BIO, can be a better therapeutics option to treat ASD.
Hua Medicine (“Hua Medicine”; SEHK: 2552) today announced that at the 6th China BioMed Innovation and Investment Conference held September 25-27 in Suzhou, China (the “CBIIC”), Professor Jianhua MA, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, as one of the principal researchers, presented the results from a clinical study called DREAM, which showed that dorzagliatin, a glucokinase activator and a first-in-class investigational drug of Hua Medicine, may make progress in diabetes remission.
The DREAM study is an observational, non-pharmacologic and non-interventional clinical study initiated by certain researchers participating in the SEED study (also known as HMM0301). The SEED study is a Phase III registered clinical study of dorzagliatin monotherapy in drug-naive Type 2 diabetes patients to observe its long-term efficacy and safety. The main objective of the DREAM study is to evaluate the ability of Type 2 diabetes patients who participated in our SEED Study and achieved glycemic control as defined by investigators, to maintain normal to near-normal glucose levels (i.e., remission of Type 2 diabetes), without any glucose-lowering medication after the completion of the SEED study for a minimum follow-up period of 52-weeks.
The DREAM study was conducted in a total of 69 patients in five clinical sites in China. The researchers comprehensively evaluated the subjects and set their individual HbA1c control goals, and the results of the research showed that the subjects had a 52-week glucose remission rate of 65.2% (95% CI, 53.4%, 77.0%)  during the research period.
Professor Jianhua MA said, “Dorzagliatin, a new class of glucokinase activator, has demonstrated the ability to effectively improve early phase insulin secretion and beta cell function and insulin resistance resulting in Type 2 diabetes remission. In the previous SEED study, dorzagliatin monotherapy also demonstrated stable long-term efficacy and a good safety profile. The DREAM study again showed positive results, where patients who reached normal blood glucose level after dorzagliatin treatment were able to maintain their blood glucose level and beta cell function after discontinuation of medication. This result will help us gain a deeper understanding of the mechanism of diabetes remission and explore more effective therapy for patients in clinical treatment. The DREAM study explores the possibility of oral dosing in diabetes remission and is of great significance in expanding the treatment options for Type 2 diabetes.”
At the CBIIC, in addition to the DREAM study results, Dr. Li CHEN, CEO, Founder and Chief Scientific Officer of Hua Medicine, also analyzed the landscape of medication for Type 2 diabetes and shared Hua Medicine’s development experience and future outlook at the session of Listed Company Roadshow.
Dr. Li CHEN said that, “China has the largest number of diabetes patients in the world, with the number of Type 2 diabetes patients in China exceeding 120 million. According to an epidemiological study published in BMJ by Chinese researchers in 2020, the prevalence of diabetes and prediabetes in China was 12.8% and 35.2%, respectively, from 2015 to 2017, and diabetes prevention and control have become a strategic imperative in addressing this major public health issue. The consensus report on diabetes remission recently released by the American Diabetes Association has sparked new thoughts among clinicians and new drug developers about how to prevent diabetes from becoming a lifelong disease. The positive results of the DREAM study have strengthened our confidence in the cure of Type 2 diabetes. Hua Medicine will continue to explore the broad prospects of monotherapy and combination therapy based on dorzagliatin, while further conducting typing studies and using a combination of big data and artificial intelligence for the precise treatment of Type 2 diabetes. Hua Medicine will also actively establish a glucokinase drug development platform based on the unmet clinical needs of the general public in China, and strive to make new breakthroughs in the fields of neurodegenerative diseases, NASH and other diseases.”
Note:  Calculated using the Kaplan-Meier methodology.
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the “Drug Manufacturing Permit” of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration, so as to realize the “First in Global, Start from China” mission objective for the benefit of diabetic patients worldwide.
About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide. Hua Medicine is listed on the Stock Exchange of Hong Kong Limited (stock code: 2552.HK)
About DREAM Study
The DREAM Study is an observational study designed and conducted by certain lead investigators who had participated in the SEED Study to evaluate the efficacy of dorzagliatin in drug-naive Type 2 diabetes patients. The Company did not design or control the DREAM Study and does not own or control the study’s underlying data, although the Company has provided assistance to the investigators in evaluating related data and findings.
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Researchers are bringing the use of acoustic waves to target and destroy cancerous tumours closer to reality.
While doctors have used low-intensity ultrasound as a medical imaging tool since the 1950s, experts at the University of Waterloo are using and extending models that help capture how high-intensity focused ultrasound (HIFU) can work on a cellular level.
Led by Siv Sivaloganathan, an applied mathematician and researcher with the Centre for Math Medicine at the Fields Institute, the study found by running mathematical models in computer simulations that fundamental problems in the technology can be solved without any risk to actual patients.
Sivaloganathan, together with his graduate students June Murley, Kevin Jiang and postdoctoral fellow Maryam Ghasemi, creates the mathematical models used by engineers and doctors to put HIFU into practice. He said his colleagues in other fields are interested in the same problems, but were coming at this from different directions.
My side of it is to use mathematics and computer simulations to develop a solid model that others can take and use in labs or clinical settings. And although the models are not nearly as complex as human organs and tissue, the simulations give a huge head start for clinical trials.
One of the obstacles that Sivaloganathan is currently working to overcome is that in targeting cancers, HIFU also poses risks to healthy tissue. When HIFU is being used to destroy tumours or cancerous lesions, the hope is that good tissue wont be destroyed. The same applies when focusing the intense acoustic waves on a tumour on the bone where lots of heat energy gets released. Sivaloganathan and his colleagues are working to understand how the heat dissipates and if it damages the bone marrow.
Other researchers working with Sivaloganathan include engineers, who are building the physical technology, and medical doctors, in particular, James Drake, chief surgeon at Hospital for Sick Children, looking at the practical application of HIFU in clinical settings.
Sivaloganathan believes HIFU will make significant changes in cancer treatments and other medical procedures and treatments. HIFU is already finding practical application in the treatment of some prostate cancers.
Its an area that I think is going to take center stage in clinical medicine, he said. It doesnt have the negative side effects of radiation therapy or chemotherapy. There are no side effects other than the effect of heat, which we are working on right now. It also has applications as a new way to break up blood clots and even to administer drugs.
Sivaloganathans new research paper on math modelling for HIFU, Dimension estimate of uniform attractor for a model of high intensity focussed ultrasound-induced thermotherapy, with co-authors Messoud Efendiyev and June Murley, was recently published in the Bulletin of Mathematical Biology.
Researchers have developed a novel method which involves a mathematical metrics to quantify and measure the correctness of performance of yoga asanas in terms of stability and steadiness.
This mathematical metrics based on Electromyography (EMG) a diagnostic procedure that evaluates the health condition of muscles, can help in assessing the correctness of performance and paves way for making appropriate corrections, thus enabling practitioners to derive maximum benefit from the asanas.
The research work led by Dr. S N Omkar along with Dr. Ramesh D V, Associate Professor, Ramaiah Medical College focused on yoga as a therapy to understand muscle behavior and performance in terms of spatial and temporal components while performing yoga asanas. The researchers used EMG to study both physical and physiological parameters.
The study carried out with support from ‘Science and Technology of Yoga and Meditation (SATYAM)’ Programme of the Department of Science and Technology, GoI assessed 60 healthy participants aged between 21 – 60 years including male and female for 2 years at the Biomechanics Lab, Indian Institute of Science (IISc), Bangalore. The data was collected for approximately 110 seconds and subjects stayed in the final position for 20 seconds with normal breathing and relaxed mind. The same procedure was followed for various yoga asanas namely Trikonasana, Vrikshasana, Veerabhadrasana-1, Veerabhadrasana-2, Veerabhadrasana-3, Parsvakonasana. Participants with a history of back pain, shoulder, or neck injuries were excluded from this study. It has been published in the ‘International Journal of Yoga’.
According to Dr Omkar, the mathematical metrics can help the yoga performer to do it with near perfection. It also gives a clear picture of the targeted muscles and an insight to the practitioner about the stability of the postures in terms of muscle activity. The practitioner can improve his/her performance with this feedback and maintain mind to muscle connections while performing yoga.
The study provides understanding of the mechanics of Yoga both from a biomechanical as well as a motor control perspective which succeeded in laying a foundational framework for future research in this area.
Devaraju V, Ashitha B R, Kshamith Alva K, Ramesh Debur V, SN Omkar, ‘A Mathematical Method for Electromyography Analysis of Muscle Functions during Yogasana’, International Journal of Yoga | Volume 2 | Issue 3 | 3rd September 2019. II.
A new research suggests that Yoga in addition to standard antidepressant treatment can bring relief to patients with Major Depressive Disorder (MDD)both clinically and biologically and can also bring about earlier remission.
The research led by Dr. MuralidharanKesavan, Professor, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore has assessed the therapeutic effects of Yoga in Major Depressive Disorder (MDD) as well as its effect on associated neurobiological underpinnings. This work was supported under the ‘Science and Technology of Yoga and Meditation (SATYAM)’Programme of the Department of Science and Technology, GoI and has been published in the ‘The Canadian Journal of Psychiatry’.
Earlier studies conducted at NIMHANS, have shown promising results of Yoga in reducing MDD symptoms, associated stress hormone levels and improving levels of inhibitory neurotransmitter called Gamma aminobutyric acid (GABA)in the brain as well as autonomic functioning of the brain. In this research, the team assessed the effectiveness of yoga therapy on clinical symptoms of depression and its mechanism of action through assessment of various biomarkers associated. They estimated biomarkers like GABA activity (Transcranial magnetic stimulation -TMS), Blood biomarkers (Immune system abnormalities via Interleukin system), emotional processing & brain activity – functional Magnetic Resonance Imaging (fMRI) Autonomic functioning – Heart rate Variability (HRV) on 70 people through 3.5years.
They also found that early intervention of yoga can lead to good outcomes and better prognosisand also effective as monotherapy in mild to moderate depression.Due to the plausible therapeutic role of yoga in enhancing recovery of patients with depression, the same is being considered for routine recommendation in clinical practice for patients with depression in IP & OP services offered at NIMHANS.
Co authors of the work:
Dr. Gangadhar B. N., Dr. Venkatasubramanian G., Dr. Rose Dawn Bharath, Dr. Sathyaprabha T.N., Dr. Kaviraj Uduppa, Dr. Mariamma Philip, Dr. Monojit from National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore and Dr. Sneha J. Karmani. Consultant Psychiatrist, Aditya Birla Hospital, Pune.
Image: Dr. Muralidharan Kesavan, Professor, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore
For more details Dr. Muralidharan Kesavan (email@example.com) can be contacted.