WAKEFIELD, MA / ACCESSWIRE / March 7, 2022 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today reported findings from data review of the Company's Brilacidin Phase 2 COVID-19 study and compassionate use of Brilacidin in critically-ill COVID-19 patients.
馬薩諸塞州韋克菲爾德/ACCESSWIRE/2022年3月7日/臨床階段生物製藥公司創新制藥（OTCQB: IPIX）（“公司”）今天公佈了該公司布里拉西丁2期 COVID-19 研究的數據審查結果，以及對危重 COVID-19 患者富有同情心地使用布里拉西丁。
"Based on analyses of our Phase 2 trial results, Brilacidin showed promising treatment effects in NEWS2 clinical improvement scores and among patients with the most elevated biomarker levels," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "These results, along with observations on the compassionate use of Brilacidin in COVID-19 related to dosing, as well as data being generated from ongoing scientific collaborations, are informing paths forward for our Brilacidin antiviral program. We believe Brilacidin has merit to help address COVID-19 and can play a role in preparing for future pandemics, given Brilacidin's unique immunomodulatory and antiviral properties. Progress in the Brilacidin antiviral program largely will be dependent upon obtaining government funding for additional clinical development and leveraging external research relationships. Going forward, our business focus will be to advance Brilacidin in other disease areas and to pursue new business opportunities through joint ventures and other investments."
創新制藥首席執行官利奧·埃利希說：“根據對我們2期試驗結果的分析，布里拉西丁在 NEWS2 臨床改善評分和生物標誌物水平最高的患者中顯示出令人鼓舞的治療效果。”“這些結果，加上對與給藥有關的 COVID-19 中富有同情心地使用 Brilacidin 的觀察，以及正在進行的科學合作生成的數據，爲我們的 Brilacidin 抗病毒項目提供了前進的道路。我們認爲，鑑於布里拉西丁獨特的免疫調節和抗病毒特性，布里拉西丁具有幫助應對 COVID-19 的優點，並且可以在爲未來的疫情做準備方面發揮作用。Brilacidin抗病毒計劃的進展將在很大程度上取決於能否獲得政府對更多臨床開發的資助，以及利用外部研究關係。展望未來，我們的業務重點將是推動Brilacidin在其他疾病領域的發展，並通過合資企業和其他投資尋求新的商機。”
Summary of Brilacidin COVID-19 Trial Design and Results
Brilacidin COVID-19 試驗設計和結果摘要
The Phase 2 trial (see NCT04784897) was a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin treatment in addition to current standard-of-care (SoC) compared to SoC alone, in 120 hospitalized patients with moderate-to-severe COVID-19.
2期試驗（見 NCT04784897）是一項隨機、雙盲、安慰劑對照、多中心研究，旨在評估Brilacidin治療以及當前的治療標準（SoC）與單獨使用SoC相比，對120名中度至重度 COVID-19 住院患者的療效和安全性。
Study treatment, Brilacidin IV or saline IV (placebo), was administered as 3 doses or 5 doses. For efficacy analyses, the main comparison was between the Brilacidin 5-dose group and the pooled placebo group.
研究治療 Brilacidin IV 或 saline IV（安慰劑）以 3 劑或 5 劑的劑量給藥。在療效分析方面，主要比較的是布里拉西丁5劑量組和合並安慰劑組。
Even with randomization--stratified by age (<= 65 yrs, >65 yrs) and severity (moderate, severe)--patients allocated to the Brilacidin treatment groups exhibited a greater degree of disease burden at baseline, as reflected by higher, on average, elevated biomarker levels (e.g., CRP, viral load), in contrast to the pooled placebo group.
即使採用隨機分組（按年齡（65歲）和嚴重程度（中度、重度）進行分層，分配到Brilacidin治療組的患者在基線時仍表現出更大程度的疾病負擔，這反映在與合併安慰劑組相比，生物標誌物水平（例如CRP、病毒載量）升高所反映的。
As previously released, Brilacidin did not show a difference compared to placebo in reducing Time to Sustained Recovery Through Day 29, the study's primary endpoint based on clinical status. There was also no difference in mortality between active and placebo, with both groups experiencing low mortality rates (7 percent) compared to other studies that evaluated patients with moderate-to-severe COVID-19. Beneficial Brilacidin treatment effects, however, were observed in NEWS2 secondary endpoints, as well as on the primary endpoint in patient subgroups, as summarized below.
正如先前發佈的那樣，與安慰劑相比，Brilacidin在縮短持續恢復時間方面沒有顯示出差異，第29天是該研究基於臨床狀態的主要終點。活性劑和安慰劑的死亡率也沒有差異，與其他評估中度至重度 COVID-19 患者的研究相比，兩組的死亡率（7％）都很低。但是，在 NEWS2 次要終點以及患者亞組的主要終點中觀察到 Brilacidin 治療的有益效果，總結如下。
Pharmacokinetic (PK) analysis (from measured plasma sample concentrations) provided comparable estimations to those seen previously in the Brilacidin IV program, although exposure was generally greater than observed prior (when comparing patients on similar treatment regimens for the indication of acute bacterial skin and skin structure infections [ABSSSI]). These new PK data will help inform any future Brilacidin IV dosing strategies.
藥代動力學（PK）分析（根據測得的血漿樣本濃度）提供的估計值與之前在Brilacidin IV計劃中看到的估計值相當，儘管暴露量通常高於先前的觀測值（比較使用類似治療方案的患者以了解急性細菌性皮膚和皮膚結構感染的適應症 [ABSSSI]）。這些新的PK數據將有助於爲未來的任何Brilacidin IV給藥策略提供信息。
Brilacidin was generally well-tolerated by patients, with an overall safety profile in COVID-19 patients consistent with previous clinical studies. The incidence of patients with at least one treatment-emergent adverse event (TEAE) was higher for Brilacidin treatment compared to placebo. However, the proportion of patients with TEAEs is similar across groups (72 percent on active, 65 percent on placebo) after excluding the Brilacidin-related adverse events of tingling (paresthesia) and hypoesthesia (numbness), which are known, transient, mostly mild, non-serious adverse events related to Brilacidin IV treatment. The incidence of serious adverse events was the same (12 percent on active, 12 percent on placebo), and no serious adverse events were reported as related to study treatment.
患者對 Brilacidin 的耐受性總體良好，COVID-19 患者的總體安全性與先前的臨床研究一致。與安慰劑相比，Brilacidin治療中出現至少一次治療緊急不良事件（TEAE）的患者的發生率更高。但是，在排除與布里拉西丁相關的刺痛（感覺異常）和感覺不足（麻木）等與布里拉西丁相關的不良事件後，各組患有TeaEs患者的比例相似（活躍時爲72％，服用安慰劑爲65％），這些不良事件是與布里拉西丁IV治療相關的已知的、短暫的、主要是輕微的、非嚴重的不良事件。嚴重不良事件的發生率相同（活性不良事件爲12％，安慰劑爲12％），沒有報告與研究治療相關的嚴重不良事件。
Secondary Endpoint Analysis
次要端點分析
- NEWS2 Scores (Intent-to-Treat Population)
- NEWS2 分數（意向治療人群）
More patients in the Brilacidin 5-dose group achieved and maintained, for at least 24 hours, a National Early Warning Score 2 (NEWS2) of <=2. By 10 days (from randomization), 97 percent of the Brilacidin 5-dose group had achieved this NEWS2 endpoint compared to 84 percent of patients in the pooled placebo group. A NEWS2 score of 2 or less is clinically meaningful as an aggregate score of 4 or less translates to low clinical risk, per NEWS2 criteria.
在Brilacidin 5劑量組中，越來越多的患者達到並維持了全國預警評分2（NEWS2）
The mean change from baseline in NEWS2 was greater for the Brilacidin treatment groups than for the pooled placebo group, at all assessment timepoints (Study Days 3, 5, 8, 11, 15, and 29).
在所有評估時間點（研究第3、5、8、11、15和29天），布里拉西丁治療組 NEWS2 中與基線相比的平均變化都大於合併安慰劑組。
NEWS2 is an ordinal scale developed by the U.K.'s Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention and is considered a valuable tool for management of COVID-19. NEWS2 is based on certain physiological parameters--respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse, level of consciousness, and temperature. NEWS2 has been used as an endpoint for several COVID-19 clinical trials.
NEWS2 是英國開發的序數量表。”s 皇家內科醫師學院旨在識別有臨床快速惡化風險的需要重症監護干預的患者，被認爲是管理 COVID-19 的重要工具。NEWS2 基於某些生理參數——呼吸率、氧飽和度、補充氧氣、收縮壓、脈搏、意識水平和體溫。NEWS2 已被用作多項 COVID-19 臨床試驗的終點。
Post-Hoc Analysis
事後分析
- Inflammatory Biomarkers: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
- 炎症生物標誌物：具有最高四分位數基準值的患者亞組（每個協議人群）
For those patients with baseline values for C-Reactive Protein (CRP) in the highest quartile (4th quartile), all patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29, compared to 77 percent of patients in the pooled placebo subgroup. Time to sustained recovery was on average shorter in the Brilacidin 5-dose subgroup compared to placebo.
對於C反應蛋白（CRP）基線值處於最高四分位數（4）的患者第四 四分位數），Brilacidin 5 劑量亞組中的所有患者在第29天之前都實現了持續康復，而合併安慰劑亞組的患者中，這一比例爲77％。與安慰劑相比，Brilacidin 5劑量亞組的持續康復時間平均較短。
Additionally, for those patients with baseline values for Interleukin-6 (IL-6) in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (89 percent compared to 67 percent on placebo). Time to sustained recovery also was on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients.
此外，對於白介素-6（IL-6）基線值處於最高四分位數的患者，在Brilacidin 5劑量亞組中，有更多的患者在第29天之前實現了持續康復（89％，而安慰劑的這一比例爲67％）。與該四分位數患者的安慰劑相比，Brilacidin 5劑量亞組的持續康復時間也平均較短。
Both CRP and IL-6 levels, when elevated at baseline, have been shown to predict worse outcomes in COVID-19 patients and our data was consistent with this. These two biomarkers have been used by other pharmaceutical companies as enrollment criteria to target COVID-19 patient populations most likely to benefit from treatment. The NIH-sponsored clinical evaluation of Humanigen's drug, lenzilumab (ACTIV-5/BET-B), was updated to include, as the trial's primary endpoint, survival without ventilation by 28 days in patients with baseline CRP levels under 150mg/l.
事實證明，當CRP和IL-6水平在基線水平升高時，可以預測 COVID-19 患者的預後會更差，我們的數據與此一致。這兩種生物標誌物已被其他製藥公司用作針對最有可能從治療中受益的 COVID-19 患者群體的註冊標準。美國國立衛生研究院贊助的Humanigen藥物lenzilumab（ACTIV-5/BET-B）的臨床評估已更新，將基線CRP水平低於150mg/l的患者在不通氣的情況下存活28天作爲該試驗的主要終點。
- Viral Load Biomarker: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
- 病毒載量生物標誌物：具有最高四分位數基準值的患者亞組（每個協議人群）
For those patients with baseline values for viral load in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (92 percent compared to 82 percent on placebo). Time to sustained recovery was also on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients. This is notable given median time from symptom onset to treatment randomization averaged 9.53 days in the Brilacidin COVID-19 trial, and thus likely occurred after peak viral load in most patients.
對於病毒載量基線值處於最高四分位數的患者，在Brilacidin 5劑量亞組中，有更多的患者在第29天之前實現了持續康復（92％，而安慰劑的這一比例爲82％）。與該四分位數患者的安慰劑相比，Brilacidin 5劑量亞組的持續康復時間也平均較短。這是值得注意的，因爲在 Brilacidin COVID-19 試驗中，從症狀發作到治療隨機分組的平均時間爲 9.53 天，因此很可能發生在大多數患者病毒載量達到峯值之後。
- Time from Onset of Symptoms to Randomization (Per Protocol Population)
- 從症狀發作到隨機分組的時間（每個協議人群）
If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study's primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
如果患者在出現 COVID-19 症狀後不到 7 天內開始研究治療，則與合併安慰劑組相比，Brilacidin 5 劑組的患者實現持續康復的速度更快（p = 0.03）。對於這些患者群體，從症狀發作起就使用布里拉西丁進行早期治療似乎對持續康復（該研究的主要終點）產生潛在的積極影響，這表明在疾病初始發作時可以得到治療的病例可能是有吸引力的靶向人群。
Multiple monoclonal antibodies targeting COVID-19, as well as the oral COVID-19 antiviral molnupiravir (Lagevrio™), failed in hospitalized patients but later achieved success in treating earlier-stage disease. The antiviral remdesivir (Veklury™) also recently exhibited substantial benefit in non-hospitalized COVID-19 patients, including an 87 percent lower risk of hospitalization or death than placebo after a 3-day intravenous course of the drug.
靶向 COVID-19 的多種單克隆抗體以及口服 COVID-19 抗病毒莫努匹拉韋（Lagevrio™）在住院患者中失敗，但後來成功治療了早期疾病。抗病毒藥物瑞德西韋（Veklury™）最近在非住院的 COVID-19 患者中也顯示出可觀的益處，包括靜脈注射該藥物 3 天后，住院或死亡風險比安慰劑低 87%。
- Standard-of-Care (SoC)
- 醫療標準 (SoC)
Review of Brilacidin Phase 2 COVID-19 trial data showed most patients (>87 percent) received treatment with systemic corticosteroids (generally at high doses, and for long durations), and treatment with mucolytics (>82 percent), antivirals (>68 percent), analgesics (>56 percent), immunosuppressants (>45 percent), anti-thrombotic agents (>97 percent), and other supportive medications as SoC for COVID-19.
對 Brilacidin 2 期 COVID-19 試驗數據的審查顯示，大多數患者（> 87%）接受了全身性皮質類固醇治療（通常爲高劑量，持續時間長），並使用粘液溶解劑（> 82%）、抗病毒藥物（> 68%）、鎮痛藥（>56%）、免疫抑制劑（>45%）、抗血栓藥物（>97%）和其他支持藥物，例如 COVID-19 的 SoC。
These seemingly aggressive SoC treatment strategies are likely attributable to the Delta variant of SARS-CoV-2, which became prevalent during trial enrollment and has been associated with significantly higher in-hospital mortality compared to earlier SARS-CoV-2 variants. Such implementation of a more aggressive COVID-19 SOC, as has been reported by other companies evaluating COVID-19 trial results, may have contributed to an overall lessening of observable Brilacidin treatment effects.
這些看似激進的 SoC 治療策略可能歸因於 SARS-CoV-2 的 Delta 變體，該變體在試驗註冊期間變得很流行，與早期的 SARS-CoV-2 變體相比，住院死亡率明顯更高。正如其他評估 COVID-19 試驗結果的公司所報告的那樣，這種更具侵略性的 COVID-19 SOC 的實施可能導致可觀察到的 Brilacidin 治療效果總體減弱。
Brilacidin Compassionate Use in COVID-19-Observed Treatment Effects
Brilacidin同情用於 COVID-19 觀察到的治療效果
Noticeable treatment effects attributed to the compassionate use of Brilacidin were reported by investigators. Patients receiving compassionate use of Brilacidin were at extremely advanced stages of disease and had exhausted other conventional treatment options. Compassionate use cases comprised Brilacidin being administered to critically-ill COVID‑19 patients over a longer duration (up to 10 days of treatment) than in the Phase 2 COVID-19 clinical trial (3 and 5 day dosing), with some patients also receiving higher and more frequent (twice daily) dosing. There appeared to be a potentially favorable treatment response based on increased Brilacidin dosing. For the Brilacidin compassionate use cases, in general, investigators observed more stable disease with initial improvements evident on chest x-rays and in COVID-19 disease biomarkers (e.g., CRP and ferritin). While nearly all of these critically-ill patients ultimately succumbed to severe hypoxic respiratory failure (secondary to COVID-19 viral pneumonia) and expired, survival time for these patients who initially were not expected to live beyond a few days was appreciably extended.
研究人員報告了因富有同情心地使用布里拉西丁而產生的明顯治療效果。接受富有同情心地使用布里拉西丁的患者處於極其晚期的疾病階段，已經用盡了其他常規治療方案。富有同情心的用例包括向危重 COVID-19 患者服用 Brilacidin 的時間比 2 期 COVID-19 臨床試驗（3 天和 5 天給藥）更長的時間（最多 10 天的治療），有些患者還會接受更高、更頻繁的劑量（每天兩次）。由於Brilacidin劑量的增加，似乎可能產生良好的治療反應。對於 Brilacidin 同情用例，總體而言，研究人員觀察到的疾病更爲穩定，胸部 X 光片和 COVID-19 疾病生物標誌物（例如 CRP 和鐵蛋白）的初步改善是明顯的。儘管幾乎所有這些危重患者最終都死於嚴重的缺氧性呼吸衰竭（繼發於 COVID-19 病毒性肺炎）並已過期，但這些最初預計壽命不會超過幾天的患者的存活時間明顯延長。
Brilacidin Antiviral Program-Planned Next Steps
Brilacidin 抗病毒計劃——計劃採取的後續措施
Future progress in the broader Brilacidin antiviral program will largely be tied to obtaining government funding for additional clinical development while benefiting from ongoing collaborative research with NIH and other scientists. Brilacidin's broad-spectrum antiviral activity is generating positive data. Publications and conference abstracts related to this research are being prepared.
更廣泛的Brilacidin抗病毒計劃的未來進展將在很大程度上取決於獲得政府資金以進行額外的臨床開發，同時受益於與美國國立衛生研究院和其他科學家正在進行的合作研究。Brilacidin的廣譜抗病毒活性正在產生積極的數據。正在編寫與這項研究相關的出版物和會議摘要。
Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)--all are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidin's treatment effects in COVID-19. For more details on the Company's Compassionate Use policy, please visit:
鑑於需要開發新的小分子抗病毒藥物和免疫調節劑，該公司計劃提交 Brilacidin，以便可能將其納入政府資助的 COVID-19 試驗平台，例如美國國立衛生研究院 ACTIV 計劃。平台試驗通常每個治療組招收數百名患者，可以更準確地評估 COVID-19 候選藥物的治療潛力。追求以生物標誌物爲導向的方法，延長布里拉西丁的劑量和治療時間，針對不同的患者群體，將布里拉西丁與表現出不同作用機制的藥物（例如瑞德西韋，考慮到強大的體外協同效應數據）聯合使用——所有這些都是未來任何布里拉西丁 COVID-19 試驗設計的可能要素。預計布里拉西丁的同情使用也將繼續下去，這可能會進一步爲布里拉西丁在 COVID-19 中的治療效果提供信息。有關公司同情使用政策的更多詳情，請訪問：
The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidin's blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration.
該公司還計劃向美國國立衛生研究院大流行抗病毒計劃（APP）尋求額外的臨床開發支持。由於Brilacidin具有阻斷和中和抗病毒特性，以及對開發鼻內靶向直接作用的抗病毒藥物的行業投資，用於預防性用途（包括評估臨床前動物模型中的布里拉西丁）特別令人感興趣。Brilacidin吸入給藥的初步配方工作已經完成，美國國立衛生研究院應用程序是擴展這項工作的潛在途徑，同時還探索了Brilacidin的皮下給藥，這種給藥途徑的生物利用度超過70％。
Pipeline Advancement, Other Business Opportunities
管道發展，其他商業機會
Efforts to advance the Brilacidin Oral Mucositis (OM) program are a key focus. The Company is presently exploring timelines and scenario planning-including the option to seek a meeting with the U.S. Food and Drug Administration towards the initiation of a Phase 3 clinical trial evaluating oral rinse Brilacidin as a new treatment for the prevention of OM in head and neck cancer patients receiving chemoradiation. Brilacidin oral formulation development work for Ulcerative Colitis continues. The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis.
推進Brilacidin口腔粘膜炎（OM）計劃的努力是重點。該公司目前正在探索時間表和情景規劃，包括尋求與美國食品藥品監督管理局會面，以啓動一項3期臨床試驗，該試驗評估口服沖洗劑Brilacidin作爲一種預防接受放化療的頭頸癌患者OM的新療法。治療潰瘍性結腸炎的 Brilacidin 口服配方開發工作仍在繼續。其許可合作伙伴Alfasigma還通知該公司，他們打算在今年啓動Brilacidin治療潰瘍性直腸炎/直腸桿菌炎的第二階段測試。
In other news, the Company is evaluating a number of potential pipeline additions and other unique business opportunities, including investments in medical-related technologies. In certain instances, management is in advanced discussions for products believed to be accretive to revenue by diversifying Innovation's portfolio. The Company will provide updates on all such matters as appropriate.
在其他新聞方面，該公司正在評估一些潛在的新增產品線和其他獨特的商機，包括對醫療相關技術的投資。在某些情況下，管理層正在就被認爲可以通過分散Innovation的投資組合來增加收入的產品進行深入的討論。公司將酌情提供所有此類事項的最新信息。
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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
Innovation Pharmicals Inc.（IPIX）是一家臨床階段的生物製藥公司，致力於開發世界一流的創新療法組合，以滿足包括炎症性疾病、癌症、傳染病和皮膚病在內的多個未得到滿足的醫療需求。
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》的安全港條款做出的前瞻性陳述，包括但不限於有關未來藥物開發計劃的陳述、有關布里拉西丁抗病毒能力和治療潛力及其對SARS-CoV-2（COVID-19）和其他病毒的潛在影響的陳述。有關未來產品開發的其他陳述，包括有關具體適應症的陳述，以及除歷史事實陳述以外的任何其他陳述。這些陳述涉及風險、不確定性和假設，可能導致公司的實際業績和經驗與這些前瞻性陳述中表達的預期業績和預期存在重大差異。在某些情況下，公司通過使用 “預期”、“相信”、“希望”、“估計”、“外觀”、“期望”、“計劃”、“打算”、“目標”、“潛力”、“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達的結果存在重大差異的其他因素包括與在美國和其他司法管轄區進行臨床前研究和臨床試驗以及尋求Brilacidin和Kevetrin的監管和許可批准相關的風險，包括但不限於公司的化合物可能無法成功完成臨床前或臨床測試，也可能無法獲得監管部門批准在美國或其他地方銷售和上市；可能無法獲得先前的測試結果將在未來的研究和試驗中複製；公司未來需要大量資金來爲其運營和研發提供資金，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床前或臨床測試，公司也不會獲得里程碑式的付款。公司向美國證券交易委員會提交的文件中包含對這些和其他風險因素的更完整描述。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。前瞻性陳述僅代表截至發佈之日公司目前獲得的信息，除非適用的法律或法規要求，否則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的結果，這些修改可能是爲了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而做出的任何修改。
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
投資者和媒體聯繫人
創新制藥公司
Leo Ehrlich
info@ipharminc.com
SOURCE: Innovation Pharmaceuticals Inc.
來源：創新制藥公司