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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

创新制药公司分析其Brilacidin新冠肺炎临床试验的全部数据集;该公司评估2022年新的管道机会
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.

马萨诸塞州韦克菲尔德/ACCESSWIRE/2021年12月7日/临床阶段生物制药公司创新制药(场外交易市场代码:IPIX)(以下简称“本公司”)今天为股东提供了有关公司进入2022年的前进战略的观点。

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.

该公司高兴地报告,截至上周,它已经收到了最近完成的Brilacidin治疗住院患者中到重度新冠肺炎的第二阶段临床试验的所有非盲法数据/数据输出。创新团队正在与生物统计合作伙伴合作探索数据-根据患者人口统计数据和基线特征、国内与海外新冠肺炎的护理标准等对不同的亚群进行更深入的分析-以潜在地确定有意义的模式和积极趋势。美国还计划对用尽所有其他治疗选择的危重新冠肺炎患者对Brilacidin的同情使用进行分析。观察到生物标志物的变化和积极的临床变化,一些同情使用Brilacidin的患者比第二阶段Brilacidin新冠肺炎试验中的患者服用Brilacidin的频率更高,持续时间更长。总的来说,这些行动将有助于为Brilacidin在来年对抗新冠肺炎的下一步行动提供信息,同时Brilacidin的广谱抗病毒特性将继续通过美国国立卫生研究院和其他科学合作进行研究。

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,该公司仍然专注于开发Brilacidin作为治疗炎症性肠道疾病(IBD),特别是溃疡性结肠炎的新疗法,并计划启动Brilacidin的第三阶段测试,作为头颈部癌症患者口腔粘膜炎(OM)的口腔漱口疗法。药物产品开发正在与专门的合同开发和制造组织(CDMO)进行,这些组织负责提炼各自的Brilacidin配方。IBD和OM的临床适应症代表了大片未得到满足的需求,具有重要的可寻址商业市场。

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,创新管理层正在进行讨论,可能会获得新管道资产的权利,以及签订新的许可协议。本公司计划根据需要提供有关这些事项的最新情况。不能保证这些事情会导致最终协议的执行,无论是暗示的还是其他的。

"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."

当我们得知Brilacidin新冠肺炎第二阶段临床研究的背线结果时,我们感到惊讶。许多因素促使我们对试验成功的预期,包括令人信服的体外培养即使在我们保持务实的情况下,我们也能取得抗击SARS-CoV-2病毒的结果。几乎所有其他制药公司,无论大小,都很难在治疗住院的新冠肺炎患者方面显示出临床疗效,“创新制药公司的首席执行官利奥·埃尔利希评论说,”在那些以开放标签的方式同情地使用Brilacidin的危重患者中,我们被告知在接受Brilacidin治疗后不久,关键的炎症生物标志物出现了明显的改善。随后患者临床状态的积极变化也被观察到。我们计划进一步审查这些数据,同时为我们的第二阶段新冠肺炎试验进行分组分析,因为这将有助于我们针对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补充说:“公司正在以战略重点向前推进。正在努力在多个方面推进Brilacidin的临床开发,并探索潜在的新管道增加,这些可能会在2022年对我们的公司产生变革性影响。”

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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.

关于创新制药公司
创新制药公司(IPIX)是一家临床阶段的生物制药公司,开发世界级的创新疗法组合,解决多种未得到满足的医疗需求领域,包括炎症性疾病、癌症、传染病和皮肤病。

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.

前瞻性陈述:本新闻稿包含根据1995年“私人证券诉讼改革法”的安全港条款作出的前瞻性陈述,包括但不限于有关未来药物开发计划的陈述、有关Brilacidin的抗病毒能力和治疗潜力及其对新冠肺炎(SARS-CoV-2)和其它病毒的潜在影响的陈述。关于未来产品发展的其他陈述,包括关于特定适应症的陈述,以及除历史事实陈述之外的任何其他陈述。这些陈述涉及风险、不确定因素和假设,可能导致公司的实际结果和经验与这些前瞻性陈述中表达的预期结果和预期大不相同。在某些情况下,该公司通过使用诸如“预期”、“相信”、“希望”、“估计”、“展望”、“预期”、“计划”、“打算”、“目标”、“潜在”、“可能”、“建议”等词语来识别前瞻性陈述。可能导致实际结果与前瞻性陈述中表述的结果大不相同的其他因素包括:在美国和其他司法管辖区进行临床前研究和临床试验以及寻求Brilacidin和Kevin etrin的监管和许可批准有关的风险,包括但不限于该公司的化合物可能无法成功完成临床前或临床测试,或获得在美国或其他地方销售和销售的监管批准;以前的测试结果可能不会在未来的研究和试验中复制;该公司需要大量药物以及大量药物的供应。, 包括根据证券购买协议出售普通股的金额和时间;公司的被许可人可能无法成功完成临床前或临床测试,公司将不会收到里程碑式的付款。有关这些和其他风险因素的更完整描述包括在该公司提交给证券交易委员会的文件中。其中许多风险、不确定性和假设超出了公司的控制或预测能力。您不应过分依赖任何前瞻性陈述。前瞻性陈述仅代表公司在发布之日目前掌握的信息,公司没有义务公开发布对任何此类前瞻性陈述的任何修订结果,除非适用法律或法规另有要求,否则这些修订可能反映本新闻稿发布之日之后的事件或情况,或反映意外事件的发生。(编者注:根据适用法律或法规的要求,这些前瞻性陈述仅代表公司目前掌握的信息,公司没有义务公开发布任何此类前瞻性陈述的修订结果,以反映本新闻稿发布后的事件或情况,或反映意外事件的发生),除非适用的法律或法规要求。

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

投资者和媒体联系
创新制药公司。
利奥·埃尔利希(Leo Ehrlich)
邮箱:info@ipharminc.com

SOURCE: Innovation Pharmaceuticals Inc.

资料来源:创新制药公司。


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