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    Home > Active Ingredient News > Endocrine System > Interview with Professor Xiaoling Cai: How far is it from us to be approved to enter Phase III clinical, oral insulin?

    Interview with Professor Xiaoling Cai: How far is it from us to be approved to enter Phase III clinical, oral insulin?

    • Last Update: 2021-06-02
    • Source: Internet
    • Author: User
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    Yimaitong reports on the spot, please do not reprint without authorization.

    Introduction: How is the development of oral insulin? How far is it from the clinic? On May 16, 2021, the 17th "2021 Peking University Diabetes Forum (PUDF)" was held at the Beijing Convention Center.

    Yimaitong has the honor to invite Professor Cai Xiaoling from Peking University People's Hospital for an exclusive interview.

    Professor Xiaoling Cai gave a wonderful sharing on the "progress in research and development of oral insulin".

    Professor Cai Xiaoling Professor Cai Xiaoling accepted an exclusive interview with Yimaitong.
    Introduction of Professor Cai Xiaoling: Department of Endocrinology, Peking University People's Hospital, Chief Physician and Associate Professor.

    He is also a youth committee member of the Diabetes Branch of the Chinese Medical Association, a member of the Education Group of the Diabetes Branch of the Chinese Medical Association, a youth member of the Endocrinology and Metabolism Branch of the Chinese Women Physicians Association, and a youth vice chairman of the Diabetes Branch of the Beijing Medical Association.

     Professor Yimaitongcai, what are the advantages of oral insulin compared with subcutaneous injection insulin? Professor Cai Xiaoling: Subcutaneous injection is insulin is currently the main method of administration.

    Although this method of administration has the advantages of high bioavailability, faster onset of action, and flexibility to adjust the dose, it also has deficiencies in the mechanism and mode of administration.

    One of the advantages of oral insulin is that it can physiologically simulate the in vivo process of insulin, which involves the first pass effect of the liver and the insulin gradient of the portal vein and systemic circulation.

    In contrast, subcutaneous administration cannot simulate physiological insulin secretion, and the liver insulin level is also significantly lower than the physiological level.
    Insufficient liver insulinization will affect liver glucose metabolism, increase the risk of blood sugar fluctuations, and aggravate insulin resistance.

    In addition, elevated peripheral insulin levels during subcutaneous injection can lead to the disappearance of the portal/peripheral insulin gradient, leading to peripheral hyperinsulinemia, which in turn leads to various hazards such as hypoglycemia, weight gain, microvascular complications, and other adverse metabolic effects.

     Secondly, compared with subcutaneous injections that can cause pain, discomfort, infection, lipodystrophy or fat hyperplasia and other injection-related adverse reactions, oral administration also has a clear advantage in improving patient compliance.

     Yimaitong has been clinically using subcutaneously administered insulin for a hundred years, but no oral insulin has been used clinically yet.
    What are the difficulties faced by oral insulin in the development process? Professor Cai Xiaoling: Oral insulin research and development began in 1922, which is similar to injectable insulin.
    It has been nearly a hundred years ago.
    There is still no mature product used in clinical practice, which shows the difficulty of research and development.

    The difficulty is mainly focused on the three barriers of physical, chemical and enzymatic action in the body, which affect the absorption and stability of the drug, making it difficult to fully exert the therapeutic effect.

     ➤Physical barrier: The structure and function of the intestinal epithelium can hinder the absorption of insulin and inhibit the penetration/absorption of insulin; ➤Chemical barrier: pH and other internal environment can affect the stability and function of the insulin structure; ➤Enzyme barrier: protease can degrade Insulin, leading to its low bioavailability.

     (Source: Professor Cai's lecture PPT) However, in recent years, researchers have actively explored new strategies to overcome the obstacles to the development of oral insulin, and finally broke through many obstacles and made certain progress.

     (Source: Professor Cai's lecture PPT) What is the progress of Yimaitong's current research on oral insulin? How far is it from clinical application? Professor Cai Xiaoling: At present, there are a variety of oral insulin products in the development process, and the hypoglycemic efficacy and safety of some products have been preliminary clinically verified.

     For example, chemically modified IN-105 has been found to improve blood glucose fluctuations after meals and inhibit C-peptide levels.
    It is currently in the phase II research phase.

    SOMA capsules have been confirmed in animal experiments and have a hypoglycemic effect equivalent to subcutaneous insulin injection.

    The ORMD-0801 IIb clinical study successfully reached the primary endpoint.
    ORMD-0801 significantly reduced nighttime blood glucose levels with good safety.
    There were no serious adverse events related to drug treatment.

    At present, the US FDA has approved ORMD-0801 to carry out Phase III clinical studies.

     (Source: Professor Cai Lecture PPT) In view of the fact that the phase III clinical trial of oral insulin has just started, it is still too early to predict when oral insulin will enter the clinic.
    According to past experience, it may take several years if everything goes well.

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