AlzeCure’s ACD856 Demonstrates Good Tolerability in Phase I Clinical Trial and is Approved for Additional Doses
AlzeCure’s ACD856 Demonstrates Good Tolerability in Phase I Clinical Trial and is Approved for Additional Doses
STOCKHOLM, SWEDEN / ACCESSWIRE / August 27, 2021 / AlzeCure Pharma (STO:ALZCUR) (FRA:AC6)
瑞典斯德哥爾摩/ACCESSWIRE/2021年8月27日/AlzeCure Pharma(STO：ALZCUR)(法蘭克福機場市場代碼：AC6)
AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer's disease and pain, today announced that the company has received approval from the Medical Products Agency to be able to give additional doses of ACD856 in the clinical phase I study (single ascending dose, SAD) with ACD856, as its good tolerability enables higher doses to be tested
AlzeCure Pharma AB(Publ)(FN STO：ALZCUR)是一家制藥公司，為影響中樞神經系統的疾病開發廣泛的候選藥物組合，項目包括阿爾茨海默氏症和疼痛。該公司今天宣佈，該公司已獲得美國醫療產品管理局(Medical Products Agency)的批准，能夠在ACD856的臨牀I期研究(單次遞增劑量，SAD)中提供額外劑量的ACD856，因為其良好的耐受性使更高劑量的藥物能夠進行測試
Data from the SAD study establish that ACD856, the lead candidate drug within the company's NeuroRestore platform, shows good tolerability with a half-life consistent with the half-life in the first clinical study with the substance. The results demonstrate that ACD856 is suitable for further clinical development as oral treatment for, among others, Alzheimer's disease.
來自SAD研究的數據表明，該公司的NeuroRestore平台內的主要候選藥物ACD856顯示出良好的耐受性，半衰期與第一次使用該物質進行的臨牀研究中的半衰期一致。結果表明，ACD856適合於進一步的臨牀開發，作為口服治療阿爾茨海默病等疾病的藥物。
The study also shows that the bioavailability is very good, which, in combination with the good tolerability in the preclinical toxicological studies, indicates that ACD856 potentially has a large therapeutic window. The positive clinical findings obtained and additional preclinical data have prompted AlzeCure to apply for a further increase in dose in the clinical trials, which has now been granted by the regulatory authority. The subsequent clinical study (multiple ascending dose, MAD) with ACD856, where repeated dosing will be evaluated, is expected to start according to plan, and as previously communicated, during the second half of 2021.
本研究還表明ACD856的生物利用度很好，再加上臨牀前毒理學研究中良好的耐受性，表明ACD856有很大的治療窗口。獲得的陽性臨牀結果和更多的臨牀前數據促使AlzeCure申請進一步增加臨牀試驗的劑量，目前已獲得監管機構的批准。隨後對ACD856進行的臨牀研究(多重遞增劑量，MAD)將評估重複劑量，預計將在2021年下半年按計劃開始，並如之前所傳達的那樣。
"We are very pleased with the good tolerability and bioavailability that ACD856 has shown. The possibility of increasing the dose is very important and will significantly strengthen the clinical development program for the candidate drug," said Johan Sandin, CSO at AlzeCure Pharma. "With its potential to improve memory functions in a number of different diseases, ACD856 may play a significant role in the treatment of indications where these key functions are impaired, such as Alzheimer's disease, sleep disorders, traumatic brain injury and Parkinson's disease."
AlzeCure Pharma公司首席信息官約翰·桑丁説：“我們對ACD856表現出的良好耐受性和生物利用度感到非常高興。增加劑量的可能性非常重要，這將大大加強該候選藥物的臨牀開發計劃。”ACD856具有改善多種不同疾病記憶功能的潛力，在治療阿爾茨海默氏症、睡眠障礙、創傷性腦損傷和帕金森氏症等這些關鍵功能受損的適應症方面可能發揮重要作用。“
"The results demonstrate that the company continues to deliver according to plan and that the substance has a good profile for the continued clinical development," said Martin Jönsson, CEO of AlzeCure. "We are now looking forward to continuing with further clinical studies. These data and the previously communicated positive results from the Phase Ib study with ACD440, where we now are preparing for a phase II study, will also stimulate potential partnership and out-licensing discussions as well as increase interest in our research platforms."
AlzeCure首席執行官馬丁·約翰松(Martin Jönsson)表示：“結果表明，該公司繼續按計劃交付藥物，該物質在繼續臨牀開發方面具有良好的形象，”AlzeCure首席執行官馬丁·約翰松(Martin Jönsson)説。我們現在期待着繼續進行進一步的臨牀研究。這些數據以及之前與ACD440進行的Ib期研究的積極結果(我們現在正在為II期研究做準備)也將刺激潛在的合作伙伴關係和授權外討論，並增加人們對我們的研究平台的興趣。“
For more information, please contact
如需更多信息，請聯繫
Martin Jönsson, CEO
Tel: +46 707 86 94 43
martin.jonsson@alzecurepharma.com
馬丁·約翰松(Martin Jönsson)，首席執行官電話：+46 707 86 94 43郵箱：martin.jonsson@alzecurepharma.com
About AlzeCure Pharma AB (publ)
關於AlzeCure Pharma AB(Publ)
AlzeCure® is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer's disease and pain - indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless.
AlzeCure®是一家瑞典制藥公司，開發新的創新葯物療法，用於治療影響中樞神經系統的嚴重疾病和狀況，如阿爾茨海默病和疼痛-目前可用的治療非常有限的適應症。該公司在納斯達克First North Premier Growth Market上市，目前正在基於三個研究平台開發幾種平行候選藥物：NeuroRestore®、Alzstatin®和Withless。
NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows for multiple indications, including Alzheimer's disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson's disease. The Alzstatin platform focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer's disease and comprises two drug candidates. Painless is the company's research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development to an early clinical phase, and is continually working on business development to find suitable outlicensing solutions with other pharmaceutical companies.
NeuroRestore由兩種有症狀的候選藥物組成，其獨特的作用機制允許多種適應症，包括阿爾茨海默氏症，以及與創傷性腦損傷、睡眠呼吸暫停和帕金森氏症相關的認知障礙。阿爾茨海默病抑制素平台的重點是開發用於阿爾茨海默病早期治療的疾病修飾和預防候選藥物，包括兩種候選藥物。無痛是該公司在疼痛領域的研究平台，包含兩個項目：ACD440和TrkA-NAM，ACD440是治療神經性疼痛的臨牀開發階段的候選藥物，TrkA-NAM針對的是骨關節炎等條件下的嚴重疼痛。AlzeCure的目標是通過臨牀前研究和開發，將自己的項目推進到早期臨牀階段，並繼續致力於業務發展，以找到與其他製藥公司合作的合適的授權解決方案。
FNCA Sweden AB, +46(0)8 528 00 399 info@fnca.se , is the company's Certified Adviser. For more information, please visit www.alzecurepharma.se .
FNCA瑞典公司電話：+46(0)8 528 00 399 info@fnca.se是該公司的認證顧問。欲瞭解更多信息，請訪問www.alzecurepharma.se。
About NeuroRestore
NeuroRestore is a platform of symptom-relieving drug candidates for disease states in which cognitive ability is impaired, e.g. Alzheimer's Disease, sleep apnea, traumatic brain injury and Parkinson's disease. NeuroRestore stimulates several important signaling pathways in the brain, which among other things leads to improved cognition. In preclinical studies with NeuroRestore we have been able to show that our drug candidates enhance communication between the nerve cells and improve cognitive ability. NeuroRestore stimulates specific signaling pathways in the central nervous system known as neurotrophins, the most well-known being NGF (Nerve Growth Factor) and BDNF (Brain Derived Neurotrophic Factor). The levels of NGF and BDNF are disturbed in several disease states and the signaling is reduced. The impaired function impairs communication between the synapses, i.e. the contact surfaces of the nerve endings, as well as reducing the possibility of survival for the nerve cells, which gives rise to the cognitive impairments. Neurotrophins play a crucial role for the function of nerve cells, and a disturbed function of BDNF has a strong genetic link to impaired cognitive ability in several different diseases, such as Alzheimer's, Parkinson's disease, traumatic brain injury and sleep disorders. There is also a link between BDNF signaling and depression, something that has been further strengthened in recent years.
關於神經恢復 NeuroRestore是一個針對認知能力受損的疾病狀態(如阿爾茨海默病、睡眠呼吸暫停、創傷性腦損傷和帕金森病)的緩解症狀藥物候選平台。NeuroRestore刺激大腦中的幾個重要信號通路，其中包括改善認知。在對NeuroRestore的臨牀前研究中，我們已經能夠證明，我們的候選藥物可以增強神經細胞之間的溝通，改善認知能力。NeuroRestore刺激中樞神經系統中的特定信號通路，稱為神經營養因子，最著名的是NGF(神經生長因子)和BDNF(腦源性神經營養因子)。NGF和BDNF水平在多種疾病狀態下受到干擾，信號轉導減弱。功能受損會損害人與人之間的溝通突觸，即神經末梢的接觸面，以及神經細胞存活的可能性降低，從而導致認知障礙。神經營養因子對神經細胞的功能起着至關重要的作用，而BDNF功能紊亂與阿爾茨海默氏症、帕金森氏病、創傷性腦損傷和睡眠障礙等多種疾病的認知能力受損有很強的遺傳聯繫。BDNF信號和抑鬱症之間也有聯繫，這一點在最近幾年得到了進一步加強。
About Alzheimer's disease
Alzheimer's disease is the most common form of dementia, affecting approximately 45 million people worldwide. Alzheimer's disease is a lethal disorder that also has a large impact on both relatives and the society. Today, preventive and disease modifying treatments are missing. The main risk factors to develop Alzheimer's are age and genetic causes. Even though the disease can start as early as between 40 and 65 years of age, it is most common after 65 years. Significant investments in Alzheimer research are being made because of the significant unmet medical need and the large cost of this disease for healthcare and society. The total global costs for dementia related diseases is estimated to about 1,000 billion USD globally in 2018. Given the lack of both effective symptomatic treatments and disease modifying treatments, the need for new effective therapies is acute. The few approved drugs on the market today have only a limited symptomatic effect and can produce dose limiting side effects. A disease modifying treatment for Alzheimer's disease is estimated to reach more than $10 billion in annual sales. In Sweden, approximately 100,000 people suffer from Alzheimer's disease with a healthcare cost of about SEK 63 billion yearly, which is more than for cancer and cardiovascular diseases combined.
關於阿爾茨海默病 阿爾茨海默病是最常見的痴呆症，全世界大約有4500萬人受到影響。阿爾茨海默病是一種致命的疾病，對親屬和社會都有很大的影響。今天，預防性治療和疾病修正治療都缺失了。患阿爾茨海默氏症的主要危險因素是年齡和遺傳因素。儘管這種疾病最早可以在40歲到65歲之間開始發病，但65歲之後最為常見。由於大量未得到滿足的醫療需求以及這種疾病對醫療保健和社會的巨大成本，人們正在對阿爾茨海默氏症的研究進行大量投資。據估計，2018年全球痴呆症相關疾病的總成本約為1萬億美元。鑑於缺乏有效的對症治療和疾病修正治療，迫切需要新的有效治療方法。目前市場上為數不多的已獲批准的藥物只有有限的症狀作用，而且可以產生劑量限制的副作用。據估計，一種治療阿爾茨海默病的疾病修飾療法的年銷售額超過100億美元。在瑞典，大約有10萬人患有阿爾茨海默氏症，每年的醫療費用約為630億瑞典克朗，比癌症和心血管疾病的總和還要多。
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SOURCE: AlzeCure Pharma
資料來源：AlzeCure Pharma
譯文內容由第三人軟體翻譯。