Phase II data joy and half AM-Pharma sepsis drugs still decided to continue research and development
Phase II data joy and half AM-Pharma sepsis drugs still decided to continue research and development
March 12, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];The rapid development of medical technology in recent years is easy to give the illusion that human beings have responded well to almost all diseases. However, this understanding can be said to be a big mistake. Taking sepsis as an example, in recent years, the research and development of new drugs for sepsis in the medical field is still in a state of stagnation. But today this dilemma is expected to be broken by AM-Pharma, a biopharmaceutical company in the Netherlands. Researchers have seen new hopes for recombinant alkaline phosphatase (recAP) therapy developed by the company to treat acute kidney injury (AKI) caused by sepsis. AKI is a common early consequence of an excessive immune response to infection in the body of a sepsis patient. Antibiotic treatment is still the first clinical choice for patients with sepsis.
Phase II clinical studies showed a mortality reduction of more than 40% in the recAP-treated group relative to the placebo group. This result led AM-Pharma to decide on a Phase III clinical study with the support of researchers, regulators and its most important partner, Pfizer. Earlier recAP has been approved by the FDA for rapid approval.
In fact, the results of this phase II clinical study can be described as dramatic. In a clinical study called STOP-AKI involving 301 patients, recAP failed to reach its primary clinical endpoint and improved renal function in the first week of treatment. However, in subsequent observations, the researchers found that after 28 days of treatment, the mortality rate of patients with sepsis was significantly reduced, and the patient did not show significant toxic side effects. Therefore, the researchers believe that this product still has the value of continuing in the clinic.
Company CEO Van den Berg said that although recAP missed its primary research endpoint, the drug did achieve its primary research goal - improving kidney damage in patients.
AM-Pharma said that the company will spend several months to develop a detailed clinical phase III research plan, and will begin to consider recAP treatment of other diseases caused by AKI and inflammatory enteritis research programs.
The data from the Phase II clinical study also allowed the company to develop recAP among the best treatment candidates in the field. According to statistics, nearly 3 million patients in Europe, the United States, and Japan suffer from kidney damage caused by sepsis each year, and 700,000 of them die from the disease.
It is a pity that drug therapy for sepsis has almost ended in failure in the past. The drug can be traced back to the 1990s. The Centocin developed by Centocor and the E5 developed by Xoma have been greatly hoped by the industry, but they eventually lost. Recently, eritoran from Eisai, talactoferrin from Agenix, and CytoFab jointly developed by AstraZeneca and BTG failed in clinical post-study. The only drug approved for the treatment of sepsis is the Lilly Xigris, which was approved in 2001. However, in the follow-up study after the drug was on the market, it was found that the benefit of the patients of Xigris was small, which also led to the unsatisfactory sales of the drug.
Sepsis refers to systemic inflammatory response syndrome (SIRS) caused by infection, which is clinically confirmed to have bacteria or highly suspicious infections. Although sepsis is caused by infection, once it develops, it follows its own pathological processes and laws, so sepsis is essentially the body's response to infectious factors. The incidence of sepsis is high, with more than 18 million cases of severe sepsis every year in the world, and 750,000 cases of sepsis in the United States each year, and this number is rising at a rate of 1.5% to 8.0% per year. The condition of sepsis is dangerous and the mortality rate is high. About 14,000 people die every day from the world, and about 215,000 people die each year in the United States. According to foreign epidemiological investigations, the mortality rate of sepsis has exceeded that of myocardial infarction, which has become the main cause of death of non-cardiac people in the intensive care unit.
In recent years, despite the significant advances in anti-infective therapy and organ function support technologies, the mortality rate of sepsis is still as high as 30% to 70%. The high cost of treatment for sepsis and the high consumption of medical resources have seriously affected the quality of life of human beings and have already caused great threats to human health. Therefore, in 2001, the European Society of Severe Diseases, the American Society of Critical Diseases and the International Forum on Sepsis launched the "surviving sepsis campain" (SSC). In 2002, several organizations in Europe and the United States co-sponsored and signed the "Barcelona Declaration". Further develop evidence-based medical evidence based on sepsis research and continuously update the SSC guidelines for the treatment of sepsis to improve the treatment of sepsis and reduce the mortality of sepsis. The SSC Guidelines were first developed in 2003 and revised again in 2008. (Sina Pharmaceutical Compilation / Sheep Pharmacist)
Article reference source: AM-Pharma still on track with sepsis drug despite mixed phase 2 readout
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