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    Home > Medical News > Latest Medical News > Recently, the phenomenon of "termination" of clinical development of pharmaceutical companies is still frequent!

    Recently, the phenomenon of "termination" of clinical development of pharmaceutical companies is still frequent!

    • Last Update: 2022-11-15
    • Source: Internet
    • Author: User
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    Recently, US AI pharmaceutical unicorn Recursion Pharmaceuticals (hereinafter referred to as "Recursion", NASDAQ: RXRX) said in a filing with the U.
    Securities and Exchange Commission (SEC) that it will end the development of REC-3599, a drug
    candidate for the treatment of GM2 gangliosidosis in infants.

    According to public information, REC-3599 originally came from Lilly, which tested the drug in a phase III study for diabetic retinopathy in adults; In 2015, Eli Lilly licensed the drug to biotech company Chromaderm as a treatment for hyperpigmentation; But in 2019, Chromaderm licensed the drug to Recursion

    Regarding the termination of development, the CEO of Recursion said the move will help the company focus more on oncology
    "REC-3599 is a drug that targets a smaller patient population, but I think it's the right decision
    for the company.
    Since the beginning of this year, there have been
    frequent clinical development termination events involving collaborative innovative drugs in the global market.
    Recently, in fact, many pharmaceutical companies have been suspended
    because of unsuccessful research and development.
    For example, on October 31, pharmaceutical company ESSA Pharma announced that Johnson & Johnson/Janssen Pharma will cease a Phase I combination therapy clinical study with its lead drug candidate, EPI-7386, mainly due to patient recruitment challenges
    It is understood that EPI-7386 is a highly selective oral androgen receptor N-terminal region (AR NTD) small molecule inhibitor
    The U.
    FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male mCRPC patients
    who are resistant to standard of care.

    Previously, Janssen and ESSA planned to conduct clinical trials of two different combination therapies for metastatic castration-resistant prostate cancer: E PI-7386 in combination with Zytiga (abiraterone) and the steroid prednisone; The other is EPI-7386 combined with Erleada (apatamide).

    According to information disclosed by ESSA, when Johnson & Johnson decided to discontinue clinical trials, 3 patients had already received a combination therapy (specific breakdown type has not been disclosed), and 2 patients observed a 90%
    drop in their prostate-specific antigen levels within 12 weeks.

    On October 24, Alpine Immune Sciences announced the termination of two clinical trials
    of a conditional CD28 co-stimulator and a dual PD-L1/CTLA-4 checkpoint inhibitor, davoceticept (ALPN-202), due to the death of a second patient.

    It is understood that Alpine will shift its research and development focus to the development of BAFF/APRIL antagonist ALPN-303 for research related to
    autoimmune diseases.
    The Phase I RUBY-1 trial of ALPN-303 in healthy volunteers, as well as preclinical studies, have shown a significant increase in efficacy
    against BAF.
    Data from a phase II RUBY trial evaluating ALPN-303 for the treatment of systemic lupus erythematosus are expected in 2026


    For pharmaceutical companies' clinical trials are frequently stopped, industry analysts believe that this does not mean that clinical trials have reached the end, and clinical trial design is related
    to many factors such as disease areas, disease indications, product innovation, and clinical demand value.
    For pharmaceutical companies, clinical trials are only a means to conduct clinical research and development, and the ultimate foothold is still the need to solve the needs of patients and continue to promote innovative products to accelerate their market

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