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Innovation Pharmaceuticals Analyzing Full Dataset for Its Brilacidin COVID-19 Clinical Trial; Company Evaluating New Pipeline Opportunities for 2022

Innovation Pharmaceuticals Analyzing Full Dataset for Its Brilacidin COVID-19 Clinical Trial; Company Evaluating New Pipeline Opportunities for 2022

創新制藥公司分析其Brilacidin新冠肺炎臨牀試驗的全部數據集;該公司評估2022年新的管道機會
Accesswire ·  2021/12/07 20:34

WAKEFIELD, MA / ACCESSWIRE / December 7, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today provides shareholders with perspectives on the Company's go-forward strategy heading into 2022.

馬薩諸塞州韋克菲爾德/ACCESSWIRE/2021年12月7日/臨牀階段生物製藥公司創新制藥(場外交易市場代碼:IPIX)(以下簡稱“本公司”)今天為股東提供了有關公司進入2022年的前進戰略的觀點。

The Company is pleased to report that as of last week it had received all unblinded data/data outputs from the recently completed Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. The Innovation team is working with biostatistics partners to explore the data-conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more-to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year, while Brilacidin's broad-spectrum antiviral properties continue to be researched through NIH and other scientific collaborations.

該公司高興地報告,截至上週,它已經收到了最近完成的Brilacidin治療住院患者中到重度新冠肺炎的第二階段臨牀試驗的所有非盲法數據/數據輸出。創新團隊正在與生物統計合作伙伴合作探索數據-根據患者人口統計數據和基線特徵、國內與海外新冠肺炎的護理標準等對不同的亞羣進行更深入的分析-以潛在地確定有意義的模式和積極趨勢。美國還計劃對用盡所有其他治療選擇的危重新冠肺炎患者對Brilacidin的同情使用進行分析。觀察到生物標誌物的變化和積極的臨牀變化,一些同情使用Brilacidin的患者比第二階段Brilacidin新冠肺炎試驗中的患者服用Brilacidin的頻率更高,持續時間更長。總的來説,這些行動將有助於為Brilacidin在來年對抗新冠肺炎的下一步行動提供信息,同時Brilacidin的廣譜抗病毒特性將繼續通過美國國立衞生研究院和其他科學合作進行研究。

As discussed previously, the Company remains focused on developing Brilacidin as a novel therapy for Inflammatory Bowel Disease (IBD), specifically Ulcerative Colitis, and also has plans to initiate Phase 3 testing of Brilacidin as an oral rinse treatment for Oral Mucositis (OM) in head and neck cancer patients. Drug product development is ongoing with specialized Contract Development and Manufacturing Organizations (CDMOs) responsible for refining the respective Brilacidin formulation. The IBD and OM clinical indications represent large areas of unmet need, with significant addressable commercial markets.

如前所述,該公司仍然專注於開發Brilacidin作為治療炎症性腸道疾病(IBD),特別是潰瘍性結腸炎的新療法,並計劃啟動Brilacidin的第三階段測試,作為頭頸部癌症患者口腔粘膜炎(OM)的口腔漱口療法。藥物產品開發正在與專門的合同開發和製造組織(CDMO)進行,這些組織負責提煉各自的Brilacidin配方。IBD和OM的臨牀適應症代表了大片未得到滿足的需求,具有重要的可尋址商業市場。

Elsewhere, Innovation management is engaged in discussions potentially to acquire rights to new pipeline assets, as well as to enter into new licensing agreements. The Company plans to provide updates on these matters as warranted. There is no guarantee, implied or otherwise, that such matters will result in the execution of definitive agreements.

在其他地方,創新管理層正在進行討論,可能會獲得新管道資產的權利,以及簽訂新的許可協議。本公司計劃根據需要提供有關這些事項的最新情況。不能保證這些事情會導致最終協議的執行,無論是暗示的還是其他的。

"We were surprised when we learned the topline results of our Phase 2 Brilacidin COVID-19 clinical study. Many factors contributed to our expectations for a successful trial, including compelling in vitro results against SARS-CoV-2, even while we remained pragmatic. Just about all other Pharmas, both large and small, have struggled to show clinical benefit in treating hospitalized COVID-19 patients," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Among critically-ill patients who received Brilacidin under compassionate use in an open label manner, we were told noticeable improvements were seen in key inflammatory biomarkers shortly after receiving Brilacidin treatment. Subsequent positive changes to patient clinical status were also observed. We plan to review these data further, alongside performing subgroup analysis for our Phase 2 COVID-19 trial, as it will help inform our efforts against COVID-19."

當我們得知Brilacidin新冠肺炎第二階段臨牀研究的背線結果時,我們感到驚訝。許多因素促使我們對試驗成功的預期,包括令人信服的體外培養即使在我們保持務實的情況下,我們也能取得抗擊SARS-CoV-2病毒的結果。幾乎所有其他製藥公司,無論大小,都很難在治療住院的新冠肺炎患者方面顯示出臨牀療效,“創新制藥公司的首席執行官利奧·埃爾利希評論説,”在那些以開放標籤的方式同情地使用Brilacidin的危重患者中,我們被告知在接受Brilacidin治療後不久,關鍵的炎症生物標誌物出現了明顯的改善。隨後患者臨牀狀態的積極變化也被觀察到。我們計劃進一步審查這些數據,同時為我們的第二階段新冠肺炎試驗進行分組分析,因為這將有助於我們針對新冠肺炎所做的努力。“

Ehrlich added, "The Company is moving ahead with a strategic focus. Efforts are underway to advance Brilacidin's clinical development on multiple fronts, as well as to explore potential new pipeline additions that could be transformational for our company in 2022."

Ehrlich補充説:“公司正在以戰略重點向前推進。正在努力在多個方面推進Brilacidin的臨牀開發,並探索潛在的新管道增加,這些可能會在2022年對我們的公司產生變革性影響。”

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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.

關於創新制藥公司
創新制藥公司(IPIX)是一家臨牀階段的生物製藥公司,開發世界級的創新療法組合,解決多種未得到滿足的醫療需求領域,包括炎症性疾病、癌症、傳染病和皮膚病。

Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its potential impact on SARS-CoV-2 (COVID-19) and other viruses. Other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation that the Company's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.

前瞻性陳述:本新聞稿包含根據1995年“私人證券訴訟改革法”的安全港條款作出的前瞻性陳述,包括但不限於有關未來藥物開發計劃的陳述、有關Brilacidin的抗病毒能力和治療潛力及其對新冠肺炎(SARS-CoV-2)和其它病毒的潛在影響的陳述。關於未來產品發展的其他陳述,包括關於特定適應症的陳述,以及除歷史事實陳述之外的任何其他陳述。這些陳述涉及風險、不確定因素和假設,可能導致公司的實際結果和經驗與這些前瞻性陳述中表達的預期結果和預期大不相同。在某些情況下,該公司通過使用諸如“預期”、“相信”、“希望”、“估計”、“展望”、“預期”、“計劃”、“打算”、“目標”、“潛在”、“可能”、“建議”等詞語來識別前瞻性陳述。可能導致實際結果與前瞻性陳述中表述的結果大不相同的其他因素包括:在美國和其他司法管轄區進行臨牀前研究和臨牀試驗以及尋求Brilacidin和Kevin etrin的監管和許可批准有關的風險,包括但不限於該公司的化合物可能無法成功完成臨牀前或臨牀測試,或獲得在美國或其他地方銷售和銷售的監管批准;以前的測試結果可能不會在未來的研究和試驗中複製;該公司需要大量藥物以及大量藥物的供應。, 包括根據證券購買協議出售普通股的金額和時間;公司的被許可人可能無法成功完成臨牀前或臨牀測試,公司將不會收到里程碑式的付款。有關這些和其他風險因素的更完整描述包括在該公司提交給證券交易委員會的文件中。其中許多風險、不確定性和假設超出了公司的控制或預測能力。您不應過分依賴任何前瞻性陳述。前瞻性陳述僅代表公司在發佈之日目前掌握的信息,公司沒有義務公開發布對任何此類前瞻性陳述的任何修訂結果,除非適用法律或法規另有要求,否則這些修訂可能反映本新聞稿發佈之日之後的事件或情況,或反映意外事件的發生。(編者注:根據適用法律或法規的要求,這些前瞻性陳述僅代表公司目前掌握的信息,公司沒有義務公開發布任何此類前瞻性陳述的修訂結果,以反映本新聞稿發佈後的事件或情況,或反映意外事件的發生),除非適用的法律或法規要求。

INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com

投資者和媒體聯繫
創新制藥公司。
利奧·埃爾利希(Leo Ehrlich)
郵箱:info@ipharminc.com

SOURCE: Innovation Pharmaceuticals Inc.

資料來源:創新制藥公司。


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