A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19

The study assessed the efficacy and safety of Brilacidin for the treatment of COVID-19 in hospitalized participants

Start Date22 Feb 2021

Sponsor / Collaborator

Innovation Pharmaceuticals, Inc.

NCT04240223 / CompletedPhase 1

A Phase 1, Single Dose Escalation Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers

This is a single-centre, blinded, randomized, placebo controlled, dose escalation study. Up to 9 healthy male volunteers will participate in the study. This study is designed to investigate the use of delayed release tablets for colonic delivery of Brilacidin.

Start Date06 Jan 2020

Sponsor / Collaborator

Innovation Pharmaceuticals, Inc.

NCT02324335 / CompletedPhase 2

Phase 2 Study to Evaluate the Efficacy & Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients With Head & Neck Cancer Receiving Chemoradiation

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation regimens used to treat cancer. This study examines the investigational drug brilacidin and its possible application in prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer.

Start Date14 Aug 2014

Sponsor / Collaborator

Innovation Pharmaceuticals, Inc.

100 Clinical Results associated with Brilacidin

100 Translational Medicine associated with Brilacidin

100 Patents (Medical) associated with Brilacidin

404

Literatures (Medical) associated with Brilacidin

31 Dec 2024·Hypertension in pregnancy

Effects of hypertensive disorders of pregnancy on the complications in very low birth weight neonates

Article

Author: Xiu, Wenlong ; Yang, Changyi ; Shi, Huiying ; Zhang, Baoquan ; Chen, Xiujuan

OBJECTIVE:

This study was designed to investigate the effects of hypertensive disorders of pregnancy (HDP) on the complications in very low birth weight (VLBW) neonates.

METHODS:

We retrospectively included VLBW neonates (<37 weeks) who were delivered by HDP pregnant women with a body weight of < 1,500 g (HDP group) hospitalized in our hospital between January 2016 and July 2021. Gestational age matched VLBW neonates delivered by pregnant women with a normal blood pressure, with a proportion of 1:1 to the HDP group in number, served as normal control.

RESULTS:

Then we compared the peripartum data and major complications between HDP group and control. The body weight, prelabor rupture of membrane (PROM), maternal age, cesarean section rate, fetal distress, small for gestational age (SGA), mechanical ventilation, RDS, necrotizing enterocolitis (NEC) (≥2 stage), Apgar score at 1 min, and mortality in HDP group showed statistical differences compared with those of the control (all p < 0.05). To compare the major complications among HDP subgroups, we classified the VLBW neonates of the HDP group into three subgroups including gestational hypertension group (n = 72), pre-eclampsia (PE) group (n = 222), and eclampsia group (n = 14), which showed significant differences in the fetal distress, Apgar score at 1 min, SGA, ventilation, RDS and NEC (≥2 stage) among these subgroups (all p < 0.05). Multivariate regression analysis showed that eclampsia and PE were the independent risk factors for SGA and NEC, respectively.

CONCLUSION:

HDP was associated with increased incidence of neonatal asphyxia, fatal distress, SGA, mechanical ventilation, RDS, NEC and mortality. Besides, eclampsia and PE were independent risk factors for SGA and NEC.

01 Oct 2024·JOURNAL OF PEDIATRICS

Hypertensive Disorders of Pregnancy and Risk of Early Brain Abnormalities on Magnetic Resonance Imaging at Term among Infants Born at ≤32 Weeks’ Gestational Age

Article

Author: Liu, Chunyan ; Barnes-Davis, Maria E ; Kline-Fath, Beth ; Parikh, Nehal A ; Ehrlich, Shelley R ; Fu, Ting Ting ; Jain, Shipra ; Habli, Mounira ; Sahay, Rashmi D

OBJECTIVE:

To evaluate the proximal effects of hypertensive disorders of pregnancy (HDP) on a validated measure of brain abnormalities in infants born at ≤32 weeks' gestational age (GA) using magnetic resonance imaging at term-equivalent age.

STUDY DESIGN:

In a multisite prospective cohort study, 395 infants born at ≤32 weeks' GA, underwent 3T magnetic resonance imaging scan between 39 and 44 weeks' postmenstrual age. A single neuroradiologist, blinded to clinical history, evaluated the standardized Kidokoro global brain abnormality score as the primary outcome. We classified infants as HDP-exposed by maternal diagnosis of chronic hypertension, gestational hypertension, pre-eclampsia, or eclampsia. Linear regression analysis identified the independent effects of HDP on infant brain abnormalities, adjusting for histologic chorioamnionitis, maternal smoking, antenatal steroids, magnesium sulfate, and infant sex. Mediation analyses quantified the indirect effect of HDP mediated via impaired intrauterine growth and prematurity and remaining direct effects on brain abnormalities.

RESULTS:

A total of 170/395 infants (43%) were HDP-exposed. Adjusted multivariable analyses revealed HDP-exposed infants had 27% (95% CI 5%-53%) higher brain abnormality scores than those without HDP exposure (P = .02), primarily driven by increased white matter injury/abnormality scores (P = .01). Mediation analyses showed HDP-induced impaired intrauterine growth significantly (P = .02) contributed to brain abnormality scores (22% of the total effect).

CONCLUSIONS:

Maternal hypertension independently increased the risk for early brain injury and/or maturational delays in infants born at ≤32 weeks' GA with an indirect effect of 22% resulting from impaired intrauterine growth. Enhanced prevention/treatment of maternal hypertension may mitigate the risk of infant brain abnormalities and potential neurodevelopmental impairments.

01 Oct 2024·CURRENT MICROBIOLOGY

New Highly Selective Antivirals for Chikungunya Virus identified from the Screening of a Drug-Like Compound Library

Article

Author: Álvarez, Diego E ; Castro, Eliana F

Chikungunya fever is a mosquito-borne disease caused by Chikungunya virus (CHIKV). Treatment of CHIKV infections is currently supportive and does not limit viral replication or symptoms of persistent chronic arthritis. Although there are multiple compounds reported as antivirals active against CHIKV in vitro, there are still no effective and safe antivirals. Thus, active research aims at the identification of new chemical structures with antiviral activity. Here, we report the screen of the Pandemic Response Box library of small molecules against a fully infectious CHIKV reporter virus. Our screening approach successfully identified previously reported CHIKV antiviral compounds within this library and further expanded potentially active hits, supporting the use of reporter-virus-based assays in high-throughput screening format as a reliable tool for antiviral drug discovery. Four molecules were identified as potential drug candidates against CHIKV: MMV1634402 (Brilacidin) and MMV102270 (Diphyllin), which were previously shown to present broad-spectrum antiviral activities, in addition to MMV1578574 (Eravacycline), and the antifungal MMV689401 (Fluopicolide), for which their antiviral potential is uncovered here.

News (Medical) associated with Brilacidin

20 Feb 2024

·www.prnewswire.com

NIH grants $2.3M to evaluate the impact of ViTrack® on maternal and child health during pregnancy

The study addresses a long-standing unmet need for wearable technology to facilitate the accurate diagnosis of high blood pressure and early detection of preeclampsia, a leading cause of complications and mortality during pregnancy NEW YORK, Feb. 20, 2024 /PRNewswire/ -- Dynocardia, developer of ViTrack, the first-of-its-kind non-invasive, wearable blood pressure (BP) and heart monitor, and NYC Health + Hospitals, the nation's largest safety net health system, are partnering on a study of hypertensive diseases of pregnancy (HDP). The study will include at least 150 women who are pregnant or have recently given birth. The perinatal study addresses a long-standing unmet need for accurate and continuous BP for reliable diagnosis of HDP and for prediction and early detection of preeclampsia. The research is being funded by a $2.3M grant from the National Institute of Health's National Heart, Lung, and Blood Institute (NHLBI). HDP, a constellation of high BP disorders that may occur during pregnancy, affects both the mother and the child and is a leading cause of pregnancy-related complications and death globally. While the risks posed by HDP have doubled over the past decade in the United States, the effects on the maternal population are not evenly distributed. African American women are at 5 times the risk from eclampsia and preeclampsia, which are severe forms of HDP that can impair the liver and kidneys, trigger strokes, and even result in death. Over the last 3 years, this risk has been exacerbated by the COVID-19 (coronavirus disease) pandemic, as evidenced by the increased incidence and severity of preeclampsia and an associated increase in preterm births and stillbirths. Automatic arm-cuff devices, currently the standard of care for monitoring BP, have two significant limitations: inaccuracy and the lack of continuous measurement capability. As a result, incorrect diagnoses of hypertension occur at a staggering rate of 30%. Moreover, pregnant women are even more vulnerable to these errors due to hemodynamic and vascular changes that occur during pregnancy. ViTrack is a one-of-a-kind blood pressure monitoring device that stands out from all other existing devices. It uses a unique combination of computer vision and artificial intelligence to accurately measure both systolic and diastolic blood pressures on a beat-to-beat basis without the need for external calibration. Furthermore, ViTrack can perform these measurements regardless of patient movement or wrist position relative to the heart, which eliminates the impact of hydrostatic pressure changes. The NHLBI has provided funding for a study that aims to evaluate the effectiveness of ViTrack in diagnosing HDP accurately and quickly. Additionally, the study intends to determine if ViTrack can provide precise measurements of 24-hour BP profiles for prediction purposes. This could lead to a meaningful improvement in patient care and management. "Hypertensive disorders of pregnancy pose a growing threat to pregnant women, especially among Black patients and other patients of color who bear a disproportionate burden of maternal mortality and severe maternal morbidity," said Wendy Wilcox, MD, Chief Women's Health Officer at NYC Health + Hospitals. "After an extensive review, the NHLBI selected ViTrack to address this challenge. We're excited about the potential to mitigate risk among the women who rely on us for their prenatal care." There is an urgent need for continuous and accurate real-world data for the prediction and early detection of preeclampsia. "We're thrilled to have a new tool that will enable us to identify subtle hemodynamic and vascular changes that can predict extreme fluctuations in blood pressure that may pose a threat to pregnant women," said Daryl Wieland, MD, Chair of OB-GYN at NYC Health + Hospitals/Jacobi|NCB. "ViTrack technology offers a new and unprecedented ability to continuously measure blood pressure and other critical heart and respiratory data, to enable predictive monitoring for early diagnosis and management of preeclampsia, and to prevent prenatal and postpartum complications," said Kecia Gaither, MD, Director of Perinatal Services and Maternal-Fetal Medicine at NYC Health + Hospitals/Lincoln. "We are truly grateful to the NHLBI for their continued support and this initial opportunity to partner with NYC H+H," said Mohan Thanikachalam, MD, cardiac surgeon and CEO of Dynocardia. Groundbreaking BP monitoring with ViTrack technology has the power to transform lives across the world. "We recognize the crucial role of accurate and continuous blood pressure monitoring in ensuring optimal care during pregnancy, especially among African American women. Given the known challenges of HDP, we believe that the implementation of ViTrack technology can significantly contribute to safeguarding and promoting the well-being of all expectant mothers." Please visit for more information. About Dynocardia Dynocardia is a biomedical device development company committed to satisfying critical unmet needs to improve healthcare worldwide. ViTrack®, the company's lead diagnostic device, is powered by proprietary technology, making it a first-of-its-kind, cuff-less device that allows for continuous, non-invasive blood pressure measurement. Unlike conventional occlusive cuff BP devices, ViTrack is a cuff-less wrist-wearable, connected, comfortable and easy-to-use device that offers direct, beat-to-beat measurement of systolic and diastolic BPs with accuracy and continuity comparable to intra-arterial lines. ViTrack, with data-rich capability that includes BP, heart rate, respiratory, and advanced heart function parameters, is poised to be a cornerstone of predictive medicine. For more information, visit and LinkedIn. About NYC Health + Hospitals NYC Health + Hospitals is the largest municipal health care system in the nation serving more than a million New Yorkers annually in more than 70 patient care locations across the city's five boroughs. A robust network of outpatient, neighborhood-based primary and specialty care centers anchors care coordination with the system's trauma centers, nursing homes, post-acute care centers, home care agency, and MetroPlus health plan—all supported by 11 essential hospitals. Its diverse workforce of more than 43,000 employees is uniquely focused on empowering New Yorkers, without exception, to live the healthiest life possible. For more information, visit and stay connected on Facebook, Twitter, Instagram and LinkedIn. Media Contact: Alan Rothenberg Glue Advertising and Public Relations [email protected] 917 885 7530 SOURCE Dynocardia

AHA

04 Dec 2023

·www.sciencedaily.com

Decades after blood pressure-related pregnancy complications, women can have changes in heart structure and function

Hispanic/Latina women with a history of hypertensive disorders of pregnancy (HDP) -- conditions marked by high blood pressure during pregnancy -- are more likely to have abnormalities in their heart structure and function decades later when compared with women without a history of HDP, according to a new study. The findings also suggest that while having high blood pressure later in life can contribute to these abnormalities, HDP play the greater role, significantly raising a woman's risk of developing cardiovascular disease. Hispanic/Latina women with a history of hypertensive disorders of pregnancy (HDP) -- conditions marked by high blood pressure during pregnancy -- are more likely to have abnormalities in their heart structure and function decades later when compared with women without a history of HDP, according to a National Institutes of Health-supported study. The findings, published in the journal Hypertension, also suggest that while having high blood pressure later in life can contribute to these abnormalities, HDP play the greater role, significantly raising a woman's risk of developing cardiovascular disease. "The changes in cardiac structure and function that this study uncovers are known predictors of cardiovascular events such as heart failure and even death," said Jasmina Varagic, Ph.D., program officer in the Vascular Biology and Hypertension branch at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH. "These findings emphasize the importance of recognizing HDP as an important risk factor for these future problems, especially in this understudied population of women." The rates of HDP, which include preeclampsia, eclampsia, and gestational hypertension, more than doubled between 2007-2019 in the U.S., with Hispanic/Latina women having the highest rate of over 60 cases per 1000 live births. Previous studies have shown that among women who have HDP, up to 20% will continue to have high blood pressure six months after giving birth and will also have up to a 10-fold lifetime risk of chronic hypertension. But researchers were unclear just how HDP was driving the high risk of cardiovascular disease many of these women later developed. "Prior to our study the question was: Do abnormalities in the structure and function of the heart develop because of the HDP itself, or because many of the women who have HDP then go on to develop chronic high blood pressure?" asked Odayme Quesada, M.D., medical director for The Christ Hospital Women's Heart Center, and lead author on the study. "Our study helps to answer this question." For the study, the researchers used participants in the NHLBI-funded Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a multi-center community-based cohort of Hispanic/Latino adults. The cohort included 5,168 women who had at least one prior pregnancy and whose average age was 58.7 years -- well past childbearing age -- at the time of the study. The participants underwent ultrasound scans to look for alterations in the structure and function of the heart, focusing on the left ventricle, considered the workhorse of the heart that pumps blood into the body. Researchers looked for alterations in the thickness and shape of the ventricle, and how well the heart squeezes and relaxes. The researchers found that prior HDP was associated with alterations in how the heart contracts and relaxes, increased thickness of the heart wall, and higher rates of abnormal geometry in the left ventricle. These abnormalities, particularly in the geometry of the left ventricle, are known to predict future cardiovascular events, including heart failure, ischemic heart disease, and sudden cardiac death. The researchers also discovered that having hypertension later in life only accounted for part of the changes seen in heart structure and function. For example, they found that hypertension experienced by the women at the time of the study explained only 14% of the risk of having abnormal geometry of the left ventricle, while the rest was explained by having HDP at the time of their pregnancies. "This underscores the importance of early surveillance for heart abnormalities in women whose pregnancy is complicated by HDP, and also the importance of managing high blood pressure to prevent later life cardiovascular disease," said Varagic. She added that factors beyond blood pressure that link HDP to later life heart abnormalities need further investigation.

AHA

21 Jun 2023

·www.globenewswire.com

Innovation Pharmaceuticals Provides Update on U.S. Patent Applications Covering Use of Brilacidin in Inflammatory Bowel Diseases, Coronaviruses and Fungal Diseases

WAKEFIELD, MA, June 21, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced the United States Patent and Trade Office (USPTO), on June 6, 2023, granted a patent, “Host Defense Protein (HDP) Mimetics for Prophylaxis and/or Treatment of Inflammatory Diseases of the Gastrointestinal Tract,” and also recently issued a Notice of Allowance for the patent application, “Arylamide Compounds For Treatment Of Viral Infections.” These allowed patents, which encompass Brilacidin protections through 2036 and 2041, respectively, further strengthen Brilacidin intellectual property rights previously granted in the U.S. and other regions. Brilacidin is a Host Defense Protein-mimetic drug candidate with broad-spectrum immunomodulatory and antimicrobial properties. Related to the claims of these newly allowed patents, Brilacidin has been tested in Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS) (by rectal enema administration), where most patients achieved clinical remission, with further progress made in the development of an oral Brilacidin formulation for treatment of Ulcerative Colitis and Crohn’s Disease. The Company out-licensed Brilacidin in UP/UPS to Alfasigma S.p.A. Brilacidin has also been evaluated in Phase 2 testing in moderate-to-severe hospitalized cases of COVID-19 (by intravenous delivery), with beneficial treatment effects observed in patient subgroups. Biomarker-based trial design (enrollment tied to specific subgroups) has been highlighted by Biomedical Advanced Research and Development Authority (BARDA) scientists as a critical step to increase the likelihood of achieving clinical efficacy of investigational drugs in COVID-19 and Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS). A separate patent application has been submitted to the USPTO for use of Brilacidin in fungal diseases. Encouraging Brilacidin pre-clinical results (in vitro and in vivo) against multiple fungal infections have been achieved, as recently published in an article in Nature Communications, and based on in vitro screening studies conducted by independent researchers. Additional in vivo testing in efficacy models against two hard-to-treat fungal pathogens is scheduled for 3Q2023. AlertsSign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/ About Innovation PharmaceuticalsInnovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, and infectious diseases. The Company is also active in evaluating other potential investment opportunities that can add value and diversify its portfolio. 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 product development plans, including with respect to specific indications; statements regarding the therapeutic potential and capabilities of the StingRay System; future regulatory developments; and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause 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 in the United States and other jurisdictions, including without limitation that compounds and devices 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. INVESTOR AND MEDIA CONTACTS Innovation Pharmaceuticals Inc. Leo Ehrlich info@ipharminc.com

Phase 2Clinical Result

100 Deals associated with Brilacidin

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KEGG	Wiki	ATC	Drug Bank
D10414	Brilacidin	-	DB12997

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	US	Innovation Pharmaceuticals, Inc.	22 Feb 2021
COVID-19	Phase 2	RU	Innovation Pharmaceuticals, Inc.	22 Feb 2021
Head and Neck Neoplasms	Phase 2	US	Innovation Pharmaceuticals, Inc.	14 Aug 2014
Mucositis	Phase 2	US	Innovation Pharmaceuticals, Inc.	14 Aug 2014
radiation oral mucositis	Phase 2	US	Innovation Pharmaceuticals, Inc.	14 Aug 2014
Bacterial Infections	Phase 2	US	Innovation Pharmaceuticals, Inc.	01 Feb 2014
Skin Diseases, Infectious	Phase 2	US	Innovation Pharmaceuticals, Inc.	01 Feb 2014
Methicillin-Resistant Staphylococcus Epidermidis (MRSE) Infection	Phase 2	CA	PolyMedix, Inc.	01 Oct 2010
Methicillin-Resistant Staphylococcus Epidermidis (MRSE) Infection	Phase 2	RU	PolyMedix, Inc.	01 Oct 2010
Methicillin-Resistant Staphylococcus Epidermidis (MRSE) Infection	Phase 2	UA	PolyMedix, Inc.	01 Oct 2010

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04784897 (CTgov)	Phase 2	COVID-19	120	Placebo (Pooled Placebo + SoC)	bdvqgymkbk(jioexsfnjo) = gotvvwepqh ezkfteglcy (amgkaurngv, xkwvzwrrdc - qnfendonwm) View more	-	16 Sep 2022
				Brilacidin (Brilacidin 3-dose + SoC)	bdvqgymkbk(jioexsfnjo) = wbmpmbnfca ezkfteglcy (amgkaurngv, zrbrsqcdxu - chsuorxgsh) View more
NCT02324335 (Brilacidin, CTgov)	Phase 2	Mucositis \| radiation oral mucositis \| Head and Neck Neoplasms	61	Placebo (Placebo Oral Rinse)	wslehcuify(ypmpxwyznv) = jbevethssx hrpozodctm (opsequwykf, knotacbsmy - hwtbhmnwoq) View more	-	16 Jan 2019
				Brilacidin (Active Oral Rinse)	wslehcuify(ypmpxwyznv) = szxvarhqbm hrpozodctm (opsequwykf, uxyibsagtl - nhtblkncjv) View more

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