HMI-115: Frequently Asked Questions About Hair Loss Treatment

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    HMI-115: Frequently Asked Questions About Hair Loss Treatment

    What is HMI-115?

    HMI-115 is an investigational monoclonal antibody that blocks the action of prolactin. It is being studied as a treatment for androgenetic alopecia and endometriosis, two conditions in which prolactin plays a key role. This is important because, until now, treatments for alopecia and endometriosis have been limited or have had significant side effects. A novel immune-based approach could offer a more effective and safer alternative.

    Who is developing HMI-115?

    The treatment is being developed by Hope Medicine in collaboration with Bayer AG. The investment from a company like Bayer demonstrates the treatment's potential and its scientific backing.

    Which companies are involved in its development?

    • Hope Medicine: Chinese company specializing in medical biotechnology, focused on developing innovative solutions.
    • Chime Biologics: Leading biopharmaceutical manufacturing company responsible for producing HMI-115.
    • Bayer AG: German multinational pharmaceutical company with experience in developing complex drugs.

    How long has HMI-115 been under investigation?: Timeline

    2019: Hope Medicine and Bayer sign a licensing agreement, marking the start of research.

    2020:
    Preclinical testing begins in monkeys, animals that share hair loss patterns with humans.

    2022: Phase IB begins in Australia, with the first human trials.

    2023-2024: Trials expand in China and show positive preliminary results.

    Where is HMI-115 being tested?

    Currently in clinical trials in China and Australia, with future trials in the US. The expansion of the trials to more countries indicates that the treatment could be on the path to global approval if the results are positive.

    How do clinical trials work?

    The studies are: International and multicenter, allowing the effectiveness of the treatment to be evaluated in diverse populations. Randomized and double-blind, meaning neither patients nor researchers know who is receiving the drug and who is receiving a placebo. This is crucial to avoid bias and ensure reliable results.

    Who can participate in the trials?

    Age: 18-65 years.

    Diagnosis: of androgenetic alopecia.

    Do not use other hair treatments.

    Note: Willing to receive haircuts in small areas.

    How is HMI-115 administered?

    By subcutaneous injection of 240 mg every two weeks. A minimally invasive and relatively easy-to-follow treatment regimen.

    Has it received official approvals?

    2022: FDA approval (U.S.) for Phase II, indicating promising initial results.

    2023: Approval in China and a manufacturing agreement with Chime Biologics, accelerating the production process.

    HMI-115 Side Effects

    So far, clinical trials have indicated that HMI-115 is well tolerated by most patients. However, like any drug in development, it can have side effects. Some of those reported include:

    • Reactions at the injection site, such as redness or swelling.

    • Mild headache in some participants.

    • Transient fatigue after administration.

    • Mild digestive discomfort in isolated cases.

    These side effects appear to be mild and transient, but studies are still ongoing to evaluate its long-term safety. It is recommended to closely monitor the results of the next phases of the clinical trial for more precise information.

    Recent Clinical Trial Results: Phase IB in Australia

    A Phase IB study in Australia yielded positive results in patients with androgenetic alopecia. These findings confirm the drug's safety and effectiveness in humans, an essential step for advancing to the next clinical phases. It's important mentioned that Hope Medicine signed an agreement with Chime Biologics to expedite the production of HMI-115, which will allow for faster and more efficient manufacturing of the drug once it is approved for marketing.

    References:

    ClinicalTrials.gov. (n.d.). Study of HMI-115 in androgenic alopecia (NCT05324293). U.S. National Library of Medicine. Retrieved on, from https://www.clinicaltrials.gov/study/NCT05324293

    PR Newswire. (2024, June 14). Positive outcome from a phase IB study in Australia treating patients with androgenic alopecia. PRNewswire. Retrieved from https://www.prnewswire.com/news-releases/positive-outcome-from-a-phase-ib-study-in-australia-treating-patients-with-androgenic-alopecia-302031051.html

    PR Newswire. (2023, October 26). Chime Biologics and Hope Medicine enter manufacturing agreement to speed up the launch of first-in-class antibody drug HMI-115 targeting endometriosis and androgenic alopecia. PRNewswire. Retrieved from https://www.prnewswire.com/news-releases/chime-biologics-and-hope-medicine-enter-manufacturing-agreement-to-speed-up-the-launch-of-first-in-class-antibody-drug-hmi-115-targeting-endometriosis-and-androgenic-alopecia-301968968.html

    Weixin.qq.com (2023, August). Recruitment for clinical trials of HMI-115 in China. Retrieved from https://mp.weixin.qq.com/s__biz=MzkwMDUyNDE0MA==&mid=2247483697&idx=1&sn=03d0b0e168bf2454d289ca5c4dc12177&scene=21#wechat_redirect