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Innovation Pharmaceuticals reports results from Phase 2 trial of brilacidin » 09:37
11/11/21
11/11
09:37
11/11/21
09:37
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Innovation Pharmaceuticals reported topline results from the Company's Phase 2 clinical trial of Brilacidin in hospitalized patients with moderate-to-severe COVID-19. Brilacidin is being developed for treatment of COVID-19 under FDA Fast Track designation. 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. Clinical status endpoints contain a degree of subjectivity that may impact outcomes of COVID-19 trials. Additional analysis of topline and all study endpoints is ongoing. "Though disappointed with these topline results, treating moderate-to-severe COVID-19 is an exceptionally difficult patient population," said Leo Ehrlich, CEO at Innovation Pharmaceuticals. "Companies, such as Merck and Regeneron, also did not show clinical benefit in these groups of patients, although both went on to refocus their development efforts in mild-to-moderate COVID-19 and achieve success. Regarding our Brilacidin antiviral program in general, collaborations with NIH scientists and academic researchers to explore Brilacidin's broad-spectrum antiviral activity in different viruses are ongoing. Initial feasibility work to formulate Brilacidin for potential prophylactic use via inhaled delivery, to leverage Brilacidin's unique virucidal and blocking antiviral properties, also is underway. There are many paths to pursue in the antiviral space. We believe Brilacidin holds tremendous promise as a differentiated antiviral drug candidate and plan to continue its development in this area of great opportunity and unmet need." Topline safety data showed Brilacidin was generally well-tolerated, with frequency of treatment-emergent adverse events similar between study arms. The number of patients who died totaled eight, four each between active and placebo. The overall mortality rate in the trial was approximately one-half of what is typically observed in this patient population. The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of intravenous Brilacidin administered for 3 or 5 days in addition to standard of care. In the trial, 120 patients were treated, with three-fourths receiving 5 days of study drug. Patients were evenly split between male and female, with a majority categorized as experiencing severe COVID-19 at baseline. Most patients were under 65 years old, with an average age of 58.

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Innovation announce last patient visit completed in Phase 2 trial of Brilacidin » 09:10
08/12/21
08/12
09:10
08/12/21
09:10
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Innovation Pharmaceuticals provided additional information regarding the status of its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients. The company is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation. Full enrollment in the 120-patient clinical trial was completed in early June 2021. The last patient follow-up visit occurred on July 30, 2021. The subject database remains blinded with the current emphasis on confirmation of all data entered at study sites, as well as completion of source data verification and the necessary checks and reviews by the data management vendor in preparation of database lock. Following database lock and transfer to the biostatistics vendor, analysis of the unblinded data from the clinical trial will begin to assess Brilacidin's performance, against placebo, across primary, secondary, and other endpoints. Topline results are anticipated to be available one week after database lock, with full analysis to follow.

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Innovation Pharmaceuticals provides update on Brilacidin » 07:19
08/02/21
08/02
07:19
08/02/21
07:19
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Innovation Pharmaceuticals provided an update on ongoing antiviral research of Brilacidin, the company's defensin-mimetic drug candidate being developed for treatment of COVID-19 under FDA Fast Track designation, by different groups of scientists. Brilacidin antiviral research updates are provided below: Brilacidin SARS-CoV-2 Manuscript: Scientists conducting laboratory testing of Brilacidin, in particular its ability to block entry of SARS-CoV-2 into human cells, have submitted their research findings for peer-review publication. These data include insights into Brilacidin's antiviral mechanisms of action and Brilacidin activity against the Alpha and Gamma SARS-CoV-2 variants. Brilacidin Human Coronavirus (H-CoV) Research: Scientists conducting laboratory testing of Brilacidin in endemic H-CoV strains have informed the company that they are reviewing potential venues to disseminate their findings, including conferences, via publication or through public release by the Company. These data show Brilacidin inhibits different H-CoV strains, supporting Brilacidin as a pan-coronavirus agent. "Taken together, the results from ongoing lab research into Brilacidin's antiviral properties by different groups of scientists only strengthens our belief in Brilacidin," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "With a highly contagious virus circulating throughout the world and continuing to mutate in dangerous ways, reducing the effectiveness of available COVID-19 treatments and vaccines, there is a global public health need to develop broad-spectrum antivirals. Our hope is that Brilacidin, which is showing an inherent ability to be resistant to viral mutations, can play a vital role in helping contain the spread of SARS-CoV-2, as the virus is likely to be an infectious disease challenge for years to come."

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Innovation Pharmaceuticals announces new In Vitro data on Brilacidin antiviral » 09:11
07/22/21
07/22
09:11
07/22/21
09:11
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Innovation Pharmaceuticals announced that new Brilacidin antiviral data, based on research conducted by George Mason University/National Center for Biodefense and Infectious Diseases researchers, was presented yesterday, July 21, 2021, at the American Society of Virology's 40th Annual Meeting. New antiviral data included Brilacidin's inhibition of SARS-CoV-2 in additional cell lines, and Brilacidin's inhibition of alphaviruses-Venezuelan Equine Encephalitis Virus, Eastern Equine Encephalitis Virus-and Rift Valley Fever Virus, a bunyavirus. "The COVID-19 pandemic, with infections, hospitalizations and deaths once again spiking, is a stark reminder that the world is in need of effective broad-spectrum antiviral countermeasures that can be readily deployed to help mitigate viral outbreaks," commented Leo Ehrlich, CEO at Innovation Pharmaceuticals. "Our Phase 2 Brilacidin clinical trial in hospitalized COVID-19 patients was fully enrolled. We remain eager to learn about Brilacidin's treatment effect in COVID-19 patients, a possible gateway indication toward evaluating Brilacidin in other acutely infectious viral diseases, building on the type of promising pre-clinical data presented at ASV 2021 by GMU scientists."

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Innovation Pharmaceuticals completes enrollment in Phase 2 trial for COVID-19 » 07:21
06/03/21
06/03
07:21
06/03/21
07:21
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Innovation Pharmaceuticals announced that it has achieved full patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients. Innovation Pharmaceuticals is developing Brilacidin for treatment of COVID-19 under U.S. FDA Fast Track designation. Complete trial enrollment comprised 120 dosed patients recruited across multiple sites. Final data collection for the last patient enrolled in the study is expected to occur in early August, which will then be followed by the process of unblinding study data and the reporting of topline study results. Based on pre-clinical studies, Brilacidin is exhibiting an ability to directly disrupt viral integrity, a potent virucidal property, enabling it to be unaffected by mutations that give rise to variants-a beneficial trait differentiating Brilacidin from other antivirals.

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Innovation files form 10-Q, says enrollment in Phase 2 brilacidin trial tops 70% » 08:27
05/13/21
05/13
08:27
05/13/21
08:27
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Innovation Pharmaceuticals announces the filing of its SEC Form 10-Q, for the quarter ended March 31, 2021. During the quarter, the Company made substantive progress in the development of Brilacidin, Innovation Pharma's flagship drug candidate in a new class of compounds called defensin-mimetics. Of particular note, in January, the U.S. Food and Drug Administration designated the investigation of Brilacidin for the treatment for COVID-19 as a Fast Track development program. In February, recruitment began for the Company's international Phase 2, ~120-patient, randomized, double-blind, placebo-controlled clinical trial evaluating Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. Early in April, enrollment in the trial reached 25 percent. Upon review of safety data, per protocol, the independent Data Monitoring Committee recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, which has been implemented and may further maximize Brilacidin's therapeutic benefits. At the end of April, enrollment in the COVID-19 trial reached 50 percent, and as of today, the Company is pleased to report enrollment now exceeds 70 percent. Since the COVID-19 outbreak, Brilacidin has garnered attention due to its unique 3-in-1 therapeutic potential-antiviral, anti-inflammatory, antimicrobial-to treat COVID-19 and associated complications. Extensive antiviral research conducted to date resulted in publication of findings related to Brilacidin's anti-SARS-CoV-2 activity in Viruses, a peer-reviewed journal, with Brilacidin also selected for academic presentations, leading to added exposure for the Company. Further, an independent Machine Learning/Artificial Intelligence model used to screen 1,482 compounds ranked Brilacidin in the top three percent of compounds predicted to be the most effective against SARS-CoV-2, the virus responsible for COVID-19. The Company is encouraged by the Brilacidin antiviral data generated thus far, as it is supportive of Brilacidin's potential to become a front-line antiviral treatment for COVID-19. Also in the pipeline, Alfasigma-the licensee of worldwide rights to develop, manufacture and commercialize rectally-administered Brilacidin for treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis-notified the Company, in April, of its intentions to commence, in 2021, a Phase 2 multinational clinical trial of Brilacidin for UP/UPS. Alfasigma has placed an order with the Company for Brilacidin drug substance needed for the trial, which the Company is in the process of supplying. Per the licensing agreement, Innovation Pharma is eligible to receive $24 million in upfront and milestone payments, and a 6 percent royalty, upon the successful marketing of Brilacidin for UP/UPS.

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Innovation surpasses 50% enrollment in phase 2 trial of Brilacidin for COVID-19 » 08:11
04/28/21
04/28
08:11
04/28/21
08:11
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Innovation Pharmaceuticals announced that enrollment has surpassed 50% of the total targeted number of randomized trial participants in its double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. "Brilacidin is the only non-peptidic defensin-mimetic drug candidate in the world currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent inhibition in vitro against different strains of coronaviruses and alphaviruses, supporting Brilacidin's potential to be developed as a broad spectrum antiviral," the company said.

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Innovation says DMC recommends increasing dosing regimen in Phase 2 trial » 07:39
04/05/21
04/05
07:39
04/05/21
07:39
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Innovation Pharmaceuticals announced that an independent Data Monitoring Committee completed its scheduled review of interim safety data in the Company's randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. Upon reaching 25 percent enrollment, recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC. Following their review, the DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company has since implemented. Recruitment for the 5-day treatment regimen has begun. Efficacy data was not reviewed by the DMC and remains blinded. The clinical rationale for consideration of expanding treatment duration to 5 days, from the initial dosing regimen of 3 days, is to provide a longer duration of systemic Brilacidin exposure at a level that can strongly suppress SARS-CoV-2 virus replication, and associated symptoms, and thus maximize therapeutic benefits to hospitalized patients with moderate or severe COVID-19. The expanded dosing regimen has particular value in that a 5-day dosing is the recommended initial treatment duration for Gilead Sciences' Veklury, the only FDA-approved antiviral drug for treatment of COVID-19. Trial data for Veklury could serve as a benchmark in evaluating Brilacidin outcomes. The Company aims to expedite enrollment in the coming weeks toward study completion and release of topline results. Two sites, in addition to the 9 currently active and recruiting patients, have been initiated, with a further two sites planned to initiate within the next week.

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Innovation Pharmaceuticals announces publication on brilacidin » 07:53
03/10/21
03/10
07:53
03/10/21
07:53
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Innovation Pharmaceuticals is pleased to report that a Machine Learning model used to screen 1,482 compounds ranked Brilacidin in the top three percent of compounds predicted to be the most effective against SARS-CoV-2, the virus responsible for COVID-19. Published in Bioinformatics, by Oxford University Press, the Machine Learning ranking is based on a compound's predicted ability, due to its physicochemical properties, to bind to coronavirus proteins and thus inhibit viral replication. The predictive framework used in this research was built by assessing the structure of the main proteins of almost 100 different viral organisms, making the model generalizable to multiple viruses, according to the study's authors. The Company is highly encouraged by this independent research suggesting Brilacidin may be one of the best drug candidates capable of attacking and destroying SARS-CoV-2 variants and other coronaviruses, while mitigating or averting the threat of drug resistance developing. A separate independent peer-reviewed in silico screening study of 11,552 compounds comprising already FDA-approved drugs and those in clinical testing, as previously released, also identified Brilacidin as one of the most promising potential inhibitors of SARS-CoV-2. These two studies complement a growing body of antiviral data-notably, positive pre-clinical Brilacidin testing results against SARS-CoV-2 in multiple cell lines and in different coronavirus strains-supporting Brilacidin's treatment potential in COVID-19. Innovation Pharma has initiated a randomized, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients.

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Innovation Pharmaceuticals announces publication on brilacidin » 09:01
03/02/21
03/02
09:01
03/02/21
09:01
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Innovation Pharmaceuticals announced the publication of a peer-reviewed scientific article-Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture-in the journal Viruses. In the paper, Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus. Testing of Brilacidin against additional SARS-CoV-2 strains is planned. Already with over a half-million deaths in the U.S. and over two million deaths worldwide attributable to COVID-19, the emergence of more transmissible and more virulent variants of the novel coronavirus is causing added concern. Last week, the U.S. FDA issued industry guidance outlining recommendations for developing vaccines, drugs and diagnostic tools based on variants. Brilacidin's ability to disrupt viral integrity suggests Brilacidin likely is not subject to resistance developing due to coronavirus variants-unlike current COVID-19 treatments, such as monoclonal antibodies and convalescent plasma, and first-generation COVID-19 vaccines. This mechanism of action supports Brilacidin as a clearly differentiated antiviral in clinical development. Currently, Brilacidin is being evaluated in a global Phase 2 clinical trial in hospitalized COVID-19 patients

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