EOM Pharmaceutical Holdings Provides an Update on Its Lead Drug Candidate EOM613
EOM Pharmaceutical Holdings Provides an Update on Its Lead Drug Candidate EOM613
MONTVALE, N.J., Nov. 7, 2023 /PRNewswire/ -- EOM Pharmaceutical Holdings, Inc. (OTC: IMUC) ("EOM") today provides an update on its clinical program for its lead drug candidate EOM613. EOM613 is a peptide-nucleic acid-based broad spectrum immune regulating agent that acts on both key pro-inflammatory and anti-inflammatory cytokines with potential therapeutic utility in treating a variety of acute and chronic inflammatory conditions.
新澤西州蒙特維爾,2023 年 11 月 7 日 /PRNewswire/ — EOM 藥業控股有限公司 (非處方藥:IMUC)(“EOM”)今天公佈了其主要候選藥物 EOM613 的臨床計劃的最新情況。EOM613 是一種基於肽核酸的廣譜免疫調節劑,可作用於關鍵的促炎和抗炎細胞因子,在治療各種急性和慢性炎症性疾病方面具有潛在的治療用途。
This agent has been previously shown to regulate cytokine expression in a variety of immune cells in cell culture, and more recently in a Phase 1/2a human clinical trial in patients hospitalized COVID-19 with cytokine-driven respiratory inflammation. Recently reported results of this trial, named RESCUE, indicated marked beneficial reductions of the soluble interleukin-2 receptor protein (sIL-2R) cytokine levels in treated patients, with a concomitant mitigation of the release of the pro-inflammatory cytokine tumor necrosis factor alpha (TNF-alpha).
該藥物先前已被證明可以調節細胞培養中各種免疫細胞中的細胞因子表達,最近在一項針對因細胞因子驅動的呼吸道炎症 COVID-19 住院的患者的 1/2a 期人體臨床試驗中。最近公佈的這項名爲RESCUE的試驗結果表明,治療患者的可溶性白介素-2受體蛋白(sil-2r)細胞因子水平明顯降低,同時緩解促炎細胞因子腫瘤壞死因子α(TNF-α)的釋放。
This clinical finding is of particular interest since the pathophysiology of inflammatory bowel disease (IBD) is known to be largely driven by the release of inflammatory cytokines in the gastrointestinal tract, in particular TNF-alpha, interleukin 12 (IL-12), interleukin-23 (IL-23) and sIL-2R. In light of these clinical trial results, the company is currently preparing to initiate an EOM613 clinical program in Crohn's disease.
這一臨床發現特別令人感興趣,因爲衆所周知,炎症性腸病(IBD)的病理生理學主要是由胃腸道中炎症細胞因子的釋放所驅動,特別是腫瘤壞死因子-α、白介素12(IL-12)、白介素-23(IL-23)和sil-2R。鑑於這些臨床試驗結果,該公司目前正準備啓動一項針對克羅恩病的 EOM613 臨床項目。
Inflammatory bowel disease is a chronic condition that encompasses Crohn's disease and ulcerative colitis. Together, the incidence of these forms of IBD, according to the data from the Centers for Disease Control and Prevention (CDC), is 3.1 million adults (1.3% of all adults) in the United States alone with an overall prevalence in 2023 of 825 per 100,000. Despite the availability of therapies such as anti-cytokine antibodies, corticosteroids and aminosalicylate classes of drugs, treatment failures are common, and the use of these drugs has been associated with some severe side-effects such as the risk of opportunistic infections. The estimated global market for IBD therapies is expected to reach $27.0 billion annually by 2030.
炎症性腸病是一種慢性病,包括克羅恩氏病和潰瘍性結腸炎。根據美國疾病控制與預防中心(CDC)的數據,僅在美國,這些形式的IBD的總髮病率就爲310萬人(佔所有成年人的1.3%),2023年的總患病率爲每10萬人中有825人。儘管存在抗細胞因子抗體、皮質類固醇和氨基水楊酸鹽類藥物等療法,但治療失敗很常見,這些藥物的使用會帶來一些嚴重的副作用,例如機會性感染的風險。據估計,到2030年,IBD療法的全球市場每年將達到270億美元。
"EOM is now planning and designing a future clinical program for Crohn's disease patients who have failed currently available therapies or are unable to tolerate them," stated Shalom Z. Hirschman, MD, Chief Medical Officer of EOM. "In previous clinical trials in AIDS, cancer cachexia and COVID-19 patients, EOM613 was demonstrated to be well-tolerated, even in very sick patients. A broad-spectrum immune regulating agent that regulates pro- and anti-inflammatory cytokines in patients without the risk of severe side effects associated with the use of antibody or corticosteroid drugs could prove to be beneficial in the treatment of Crohn's disease and ulcerative colitis."
EOM首席醫學官Shalom Z. Hirschman醫學博士表示:“EOM現在正在爲目前可用的療法失敗或無法耐受的克羅恩氏病患者規劃和設計一項未來的臨床計劃。”“在先前針對艾滋病、癌症惡病原和 COVID-19 患者的臨床試驗中,EOM613 被證明具有良好的耐受性,即使在病情嚴重的患者中也是如此。一種廣譜免疫調節劑可以調節患者的促炎和抗炎細胞因子,而不會因使用抗體或皮質類固醇藥物而產生嚴重副作用的風險,可能被證明有益於克羅恩氏病和潰瘍性結腸炎的治療。”
EOM is planning to undertake IND-enabling animal toxicology and preclinical studies relevant to Crohn's disease. EOM is also assembling a team of key opinion leader gastroenterologists, who are experts in clinical research relating to novel treatment approaches to IBD, to advise on the design and execution of the planned clinical trial.
EOM正計劃開展與克羅恩氏病相關的支持IND的動物毒理學和臨床前研究。EOM還組建了一個由關鍵意見領袖胃腸病學家組成的團隊,他們是與IBD新治療方法相關的臨床研究專家,他們就計劃中的臨床試驗的設計和執行提供建議。
On September 1, 2023, EOM filed a provisional patent application for EOM613 for use in inflammatory bowel disease with the United States Patent and Trademark Office (USPTO).
2023 年 9 月 1 日,EOM 向美國專利商標局 (USPTO) 提交了用於炎症性腸病的 EOM613 臨時專利申請。
According to the USPTO, a provisional application for a patent is a U.S. national application filed under 35 U.S.C. §111(b). A provisional application is not required to have a formal patent claim or an oath or declaration. Provisional applications also should not include any information disclosure (prior art) statement since provisional applications are not examined. A provisional application provides the means to establish an early effective filing date in a later filed nonprovisional patent application filed under 35 U.S.C. §111(a). It also allows the term "Patent Pending" to be applied in connection with the description of the invention.
根據美國專利商標局的規定,臨時專利申請是根據美國法典第35篇第111(b)條提交的美國國家申請。臨時申請無需提出正式的專利主張或宣誓或聲明。臨時申請也不應包含任何信息披露(現有技術)聲明,因爲臨時申請不經過審查。臨時申請提供了在後來根據《美國法典》35篇第111(a)條提交的非臨時專利申請中確定提前生效申請日期的手段。它還允許將 “專利申請中” 一詞與本發明的描述結合使用。
"EOM's priority is to initiate a clinical program in inflammatory bowel disease as soon as possible," added Irach B. Taraporewala, PhD, Chief Executive Officer of EOM. "We believe that EOM613 could potentially make an important contribution to the treatment of this disease and the welfare of patients as a potentially well-tolerated alternative to current biologic and non-biologic therapies."
EOM首席執行官Irach B. Taraporewala博士補充說:“EOM的首要任務是儘快啓動炎症性腸病的臨床項目。”“我們相信,作爲當前生物和非生物療法的潛在耐受性良好的替代方案,EOM613 有可能爲這種疾病的治療和患者的福利做出重要貢獻。”
About EOM613
關於 EOM613
EOM's lead asset, EOM613, is an investigational, novel peptide-nucleic acid solution immunomodulator believed to have both anti- and pro-inflammatory broad-spectrum cytokine effects. In human cell culture studies, EOM613 demonstrated a unique "dynamic dual action" by suppressing or stimulating monocytes and macrophages depending on the activation state and environment of those key immune cells. It is hypothesized that this dynamic dual-action may overcome a limitation of many approved immunomodulators that only reduce the inflammatory state without achieving immune system balance.
EOM 的主要資產 EOM613 是一種正在研究的新型肽核酸溶液免疫調節劑,被認爲具有抗炎和促炎的廣譜細胞因子作用。在人體細胞培養研究中,EOM613 根據關鍵免疫細胞的激活狀態和環境,通過抑制或刺激單核細胞和巨噬細胞,表現出獨特的 “動態雙重作用”。據推測,這種動態雙重作用可以克服許多經批准的免疫調節劑的侷限性,這些藥物只能在不實現免疫系統平衡的情況下降低炎症狀態。
In a prior Phase 2 open-label study, EOM613 had previously shown beneficial effects in stabilizing the weight and improving the functional status of patients with advanced malignancies who also had cancer cachexia (the debilitating condition of muscle wasting, fatigue and weight loss) in Stage III and Stage IV cancer, the pathophysiology of which is largely driven by pro-inflammatory cytokines. As resources allow, EOM plans to conduct future clinical trials in cancer cachexia, for which there are no approved drug therapies in the US.
在先前的一項2期開放標籤研究中,EOM613 此前已顯示出有益於穩定晚期惡性腫瘤患者的體重和改善其功能狀態,這些患者在III期和IV期癌症中也患有癌症惡病症(肌肉萎縮、疲勞和體重減輕等使人衰弱的狀態),其病理生理學主要由促炎細胞因子驅動。在資源允許的情況下,EOM計劃在未來對癌症惡病症進行臨床試驗,而美國尚無批准的藥物療法。
About EOM Pharmaceutical Holdings, Inc.
關於 EOM 製藥 控股公司。
EOM Pharmaceutical Holdings, Inc. is a clinical-stage company focused on developing novel drugs with the potential to transform therapeutic paradigms and improve quality of life in patients suffering from debilitating and sometimes deadly diseases. The Company was founded with a specific vision to pursue innovative approaches to rescue, repair, and restore health of patients with urgent and unmet medical needs. For more information about EOM Pharmaceuticals, please visit .
EOM Pharmaceutical Holdings, Inc. 是一家處於臨床階段的公司,專注於開發新藥,這些藥物有可能改變治療模式,改善患有使人衰弱、有時甚至是致命疾病的患者的生活質量。該公司成立的具體願景是尋求創新的方法來拯救、修復和恢復有緊急和未得到滿足的醫療需求的患者的健康。有關EOM Pharmicals的更多信息,請訪問 。
Forward Looking Statements
前瞻性陳述
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify these statements by forward-looking words such as "may," "will," "continue," "anticipate," "intend," "could," "project," "expect" or the negative or plural of these words or similar expressions, and other similar terms. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, EOM's ability to develop and commercialize its product candidates; EOM's ability to obtain and maintain regulatory approval of product candidates; EOM's ability to operate in a competitive industry and compete successfully against competitors that have greater resources; EOM's reliance on third parties; EOM's ability to obtain and adequately protect intellectual property rights for product candidates; and the effects of COVID-19 on clinical programs and EOM's business operations. Any forward-looking statements in this press release speak only as of the date of this press release. EOM assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
本新聞稿包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的前瞻性陳述。在某些情況下,您可以通過前瞻性詞語來識別這些陳述,例如 “可能”、“將”、“繼續”、“預期”、“打算”、“可能”、“項目”、“期望” 或這些詞語或類似表達方式的否定或複數,以及其他類似的術語。前瞻性陳述不能保證未來的業績,存在風險和不確定性,這些風險和不確定性可能導致實際業績和事件與預期的存在重大差異,包括但不限於EOM開發和商業化候選產品的能力;EOM獲得和維持監管部門對候選產品的批准的能力;EOM在競爭激烈的行業中運營併成功與擁有更多資源的競爭對手競爭的能力;EOM對第三方的依賴;獲得和充分保護候選產品的知識產權;以及 COVID-19 對臨床項目和 EOM 業務運營的影響。本新聞稿中的任何前瞻性陳述僅代表截至本新聞稿發佈之日。在本新聞稿發佈之日之後,無論是由於新信息、未來事件還是其他原因,EOM都沒有義務更新前瞻性陳述。
SOURCE EOM Pharmaceutical Holdings
來源 EOM 製藥控股公司