Ad hoc announcement pursuant to Art. 53 LR Relief Therapeutics’ Wholly Owned Subsidiary, APR Applied Pharma Research, Reports Data Published in the Peer Reviewed Journal, Nutrients, Indicating Additional Potential Benefits of Its Physiomimic™ Technology
• Data In Healthy Volunteers Suggests That APR’s Controlled Release Amino Acid Mix, PKU GOLIKE®, May Be Key To Reducing Catabolic Events In Patients With Phenylketonuria (“PKU”), Improving Utilization Of Amino Acids And Quality Of Life
Geneva, Switzerland, September 21, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA (“APR”), reported data published in the peer reviewed journal, Nutrients, indicating additional potential benefits of the company’s Physiomimic™ Technology to the management of patients suffering from phenylketonuria (“PKU”).
The paper, entitled, “Nitrogen Balance after the Administration of a Prolonged-Release Protein Substitute for Phenylketonuria as a Single Dose in Healthy Volunteers,” provides a further evaluation of published data from APR’s previously reported, randomized, controlled, single-dose crossover trial in healthy volunteers which showed that a prolonged-release amino acid (AA) mixture, formulated with Physiomimic Technology, significantly slowed down the release and reduced the peak plasma concentrations of essential AAs compared with a free AA mixture. Authors of the current paper, including Anita MacDonald, Ph.D. and Ania C. Muntau, M.D, renowned experts in the field of metabolic diseases, concluded that the controlled release amino acid mix (PKU GOLIKE®), given its ability to prolong the release of AAs, appears to be key to reducing catabolic events in patients with PKU, resulting in a more efficient utilization of AAs for protein synthesis and, therefore, an improved quality of life.
“The paper’s conclusions reaffirm our belief as to the benefits of our patented Physiomimic Technology, the distinct advantages of our PKU GOLIKE® family of products, and the potential additional advantages conferred by the product’s unique ability to prolong the release of AAs,” stated Paolo Galfetti, Chief Executive Officer of APR and President of Relief Europe. “The Physiomimic Technology allows for a formulation of AAs which we believe leads to a physiological absorption profile more closely resembling the absorption profile of natural proteins. Based on the results published in the paper, we plan to explore
additional clinical assessments to support the benefits of AAs physiological absorption associated with PKU GOLIKE and the patented pharmaceutical Physiomimic Technology behind it.”
“The strong clinical results are a testament to the potential benefits of PKU GOLIKE® as compared to non- prolonged release AA supplementation,” stated Raghuram (Ram) Selvaraju, Chairman of the Board of Relief. “PKU GOLIKE® has been granted Orphan Drug Designation in the U.S. and further clinical studies on the benefits of the Physiomimic Technology will help as we pursue PKU GOLIKE® as a prescription product. In the meantime, we will focus on the commercial expansion and refinement of marketing activities to facilitate the growth of this product line in Europe.”
About PKU GOLIKE The PKU GOLIKE family of products are food for special medical purposes (FSMP) consisting of a phenylalanine-free amino acid mix in granules. Engineered with the Company’s patented Physiomimic Technology platform, PKU GOLIKE® is the first prolonged-release amino acid product, characterized by a special coating that ensures a better physiological absorption of the amino acids, while also masking their unpleasant taste, odor and aftertaste.
About Phenylketonuria or PKU PKU is a rare inherited disorder caused by a defect of the enzyme needed to break down phenylalanine, leading to a toxic buildup of phenylalanine when eating foods that contain protein or aspartame. Excessive levels of phenylalanine in the blood cause accumulation in the brain, which hampers proper brain development and results in neurophysiological dysfunction. Treatment of PKU is lifelong, requiring patients to follow a strict diet that severely limits phenylalanine (and, thus, protein) content. This necessitates supplementation of amino acid-based foods for special medical purposes (FSMP) to prevent protein deficiency and optimize metabolic control.
ABOUT RELIEF Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH bring a diverse pipeline of marketed and development-stage programs.
Relief Reports Half-Year 2021 Results and Provides Corporate Update
Geneva, Switzerland, September 24, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today reported its results for the half-year ended June 30, 2021 and provided a corporate update. “While we await the FDA’s decision on the Emergency Use Authorization (EUA) for IV RLF-100 (aviptadil), filed by our collaboration partner NeuroRx, Inc. (NeuroRx), we have successfully transformed Relief into a fully-integrated, multi-product, revenue-generating biopharmaceutical company,” stated Raghuram Selvaraju, Ph.D., Chairman of the Board of Directors of Relief. “A critical component of our success so far this year was the acquisition of APR Applied Pharma Research SA (APR), which expanded and diversified our specialty drug pipeline, added a number of key commercialized products, including the PKU GOLIKE® family of products for the treatment of phenylketonuria (PKU), provided a European based commercial infrastructure that we hope to leverage for future product launches, including ACER-001, and offers an internal R&D capability that we plan to use for the development our own products as well as for third- party products on a fee for service basis.” Dr. Selvaraju continued, “Through our collaboration with Acer Therapeutics, we recently filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for ACER-001, a proprietary powder formulation of sodium phenylbutyrate (NaPB), designed to be both taste-masked and immediate release, for the treatment of urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). We look forward to the potential acceptance of the filing for regulatory review, which we expect to receive next month.” “Also important was our recent acquisition of AdVita Lifescience GmbH (AdVita), from which we gained key pending intellectual property that may cover an improved inhaled formulation of RLF-100 (aviptadil), in development for a number of lung diseases, including acute respiratory distress syndrome (ARDS), and checkpoint inhibitor-induced pneumonitis (CIP). In parallel, IV RLF-100 continues to be evaluated as a treatment for severely ill COVID-19 patients, while the inhaled formulation is being tested in two clinical trials, one for patients with critical COVID-19 and another for moderate and severe COVID-19 patients. As we look ahead, and with a firm financial footing in place, we will maintain our commitment to pursuing additional strategic opportunities, both in-license and acquisition related, in order to aggressively expand and diversify our business.”
Ad hoc announcement pursuant to Art. 53 LR
Clinical Development Highlights: RLF-100 (aviptadil), IV • In March 2021, Relief’s collaboration partner, NeuroRx, Inc. (NeuroRx) announced top-line 60-day results for the phase 2b/3 trial of RLF-100™ for the treatment of patients with critical COVID-19 respiratory failure. These findings formed the basis for NeuroRx’s Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA). • In April 2021, NeuroRx announced that RLF-100 had been selected for inclusion in TESICO (Therapeutics for Severely Ill Inpatients with COVID-19), an international, phase 3, multicenter clinical trial being sponsored by the U.S. National Institutes of Health (NIH). • In June 2021, NRx Pharmaceuticals Inc. (NRx), the parent company of NeuroRx, announced that NeuroRx had submitted its EUA application to the FDA for the use of RLF-100 in the treatment of critically ill COVID-19 in patients with respiratory failure. NeuroRx also reported that it plans to submit a New Drug Application (NDA) to the FDA. • In June 2021, NRx announced additional positive results from the RLF-100 U.S. Expanded Access Protocol (EAP). These EAP data were then submitted to the FDA and were characterized by NRx as “real world” evidence in support of the findings from the phase 2b/3 trial. • In July 2021, NRx reported that it identified a statistically significant effect of RLF-100 in preventing the sharp rise in cytokines, commonly associated with mortality in patients with COVID-19. The data was collected as part of the ongoing U.S. phase 2b/3 trial and NeuroRx reported that it had submitted these findings to the FDA as a supplement to the pending EUA application. • In July 2021, NRx announced the successful validation of the commercial formulation of RLF-100 for IV use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions. • In July 2021, NRx announced that the Nation of Georgia's Prime Minister and Minister of Health had issued an EUA for RLF-100. • In August 2021, NRx provided a safety update on RLF-100 which is being tested in the ACTIV-3 Critical Care phase 3 study sponsored by the NIH, designed to evaluate RLF-100 and remdesivir in critical COVID-19 patients, as a monotherapy and in combination against placebo. They reported that the study's Data Safety Monitoring Board found no new safety concerns in the trial and recommended continued enrollment. • In August 2021, NRx reported a new analysis showing that patients with acute respiratory failure due to Critical COVID-19 who were treated with aviptadil demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. NRx noted that this analysis appears to support its plan to submit an application for Breakthrough Therapy Designation to the FDA and that, if granted, could confer Priority Review to the aviptadil NDA, when submitted.
Moin Regi ! Wieso Rattenfänger ? Alle Infos die ich hier teile sind verlinkt und zum nachlesen . Unter Rattenfängerei verstehe ich das verbreiten von Unwahrheiten oder sehe ich hier was falsch ? Jeder sollte im Stande sein sich eine eigene Meinung bilden zu können . Rattenfängerei sieht wahrlich anders aus . Euch Allen noch ein schönes Wochenende zum relaxen !! :-)
Hallo Zusammen, bin mit einer Minniposition investiert und normalerweise nur stiller Mitleser. Ich bin Ineos dankbar für seine Recherchen und den dafür benötigten Zeitaufwand den er dafür erbringt. Ich weiß überhaupt nicht, wie er an all diese Informationen kommt, sie bringen mich aber dazu meine Vorgehensweise in diesem Wert zu prüfen und auch etwas zu steuern. Aber für alle meine Entscheidungen bin ich allein verantwortlich, egal ob Verkauf, oder Kauf, kein Ineos, oder irgend ein proffssioneller Anlageberater. Aus diesem Grund ist er für mich kein Rattenfänger.
Allen Mitstreitern ein schönes Wochenende und gute Anlageentscheidungen
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NRx Pharmaceuticals Announces Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMI (aviptadil) September 27, 2021 7:04am EDT Download as PDF - ZYESAMI™ (aviptadil) Has Previously Demonstrated a Statistically Significant Increase in Survival of Highly Comorbid COVID-19 Patients in Two 60-day Trials - In a Study of Highly Comorbid Patients, ZYESAMI Provided a Threefold, Statistically Significant Increase in Likelihood of Survival at One Year
RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage, biopharmaceutical company, today announced top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™.
"These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies," said Dr. J. Georges Youssef.
Between June and September 2020, a trial was conducted at a leading tertiary care hospital involving patients with Critical COVID-19 whose level of comorbidity excluded them from the randomized phase 2b/3 clinical trial of ZYESAMI. A statistically significant difference in both survival and recovery from respiratory failure was reported at 28 days. Those findings are soon to be published in a peer-reviewed journal.
Participants in this trial have now been followed for one year from initial enrollment. Top-line results show a statistically significant (P<.0001) 3-fold advantage in likelihood of being alive at one year post treatment (60% vs. 20%) among those treated with ZYESAMI, in addition to standard of care, compared to those who received the standard of care alone. Assignment to ZYESAMI in the trial was based on the specific medical team which admitted the patient to the intensive care unit (ICU). Once in the ICU, all patients were cared for by the same medical team, and according to the same treatment protocols.
"We are still learning so much about COVID-19, especially in patients already managing chronic medical conditions, and continuing to recover from COVID-19" said Dr. J. Georges Youssef, the Principal Investigator who serves as Head of Academic Pulmonary Medicine at Houston Methodist Hospital and as Assistant Professor of Clinical Medicine at Weill Cornell Medical College. "These latest data are encouraging and will help those of us on the frontlines treat the sickest COVID patients, potentially providing new treatment options and strategies."
These one-year findings are consistent with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI. ZYESAMI Remains Under Review by the US Food and Drug Administration for Emergency Use Authorization in Patients Suffering Critical Covid-19 with Respiratory Failure.
About ZYESAMI™ (aviptadil)/VIP in COVID-19
ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP). Aviptadil binds specifically to the alveolar type II cell (AT2) in the air sac (alveolus) of the lung, where it has demonstrated potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury and inflammation. Aviptadil stimulates AT2 cells to produce the surfactant that coats the lining of the lungs to facilitate oxygen exchange with blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.
COVID-19-related respiratory failure is caused by selective infection of the ATII cell by the SARS-CoV-2 virus. The AT2 cells are vulnerable because of their (ACE2) surface receptors, which serve as the route of entry for the virus. Coronavirus infection of the AT2 cell shuts down surfactant production, triggers the formation of inflammatory cytokines, and causes cell death (cytopathy). Aviptadil is shown to upregulate surfactant production, block Coronavirus replication in the AT2 cell, block cytokine synthesis, and prevent viral-induced cell death (cytopathy). Other than ZYESAMI™, no currently proposed treatments for COVID-19 specifically target this mechanism of action.
About NRx Pharmaceuticals
NRx Pharmaceuticals (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing Phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx also has the BriLife™ vaccine for COVID-19 in clinical trials and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.
NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.
This announcement of NRx Pharmaceuticals Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.
The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above.
- ZYESAMI™ (Aviptadil) hat in zwei 60-Tage-Studien zuvor eine statistisch signifikante Erhöhung des Überlebens von COVID-19-Patienten mit hoher Komorbidität gezeigt.
- In einer Studie mit hochkomorbiden Patienten ergab ZYESAMI eine dreifache, statistisch signifikante Erhöhung der Überlebenswahrscheinlichkeit nach einem Jahr.
- Diese Ergebnisse werden demnächst in einer von Fachleuten begutachteten Zeitschrift veröffentlicht.
RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), ein biopharmazeutisches Unternehmen in der klinischen Phase, gab heute Top-Line-Daten bekannt, die eine Verbesserung der Ergebnisse nach einem Jahr bei stark komorbiden Patienten mit COVID-19 zeigen, die mit ZYESAMI™ behandelt wurden.
Zwischen Juni und September 2020 wurde an einem führenden Tertiärkrankenhaus eine Studie mit Patienten mit kritischem COVID-19 durchgeführt, deren Komorbidität sie von der randomisierten klinischen Phase-2b/3-Studie mit ZYESAMI ausschloss. Nach 28 Tagen wurde ein statistisch signifikanter Unterschied sowohl bei der Überlebensdauer als auch bei der Erholung vom Atemversagen festgestellt. Diese Ergebnisse werden demnächst in einer von Fachleuten begutachteten Zeitschrift veröffentlicht. Die Teilnehmer an dieser Studie wurden nun ein Jahr lang ab dem Zeitpunkt der Aufnahme in die Studie beobachtet. Die ersten Ergebnisse zeigen einen statistisch signifikanten (P<.0001) dreifachen Vorteil bei der Wahrscheinlichkeit, ein Jahr nach der Behandlung noch am Leben zu sein (60 % gegenüber 20 Wacko bei denjenigen, die zusätzlich zur Standardbehandlung mit ZYESAMI behandelt wurden, im Vergleich zu denjenigen, die nur die Standardbehandlung erhielten. Die Zuteilung zu ZYESAMI in der Studie erfolgte auf der Grundlage des medizinischen Teams, das den Patienten in die Intensivstation (ICU) aufnahm. Auf der Intensivstation wurden alle Patienten von demselben medizinischen Team und nach denselben Behandlungsprotokollen betreut. "Wir lernen immer noch viel über COVID-19, insbesondere bei Patienten, die bereits chronische Erkrankungen haben und sich von COVID-19 weiter erholen", sagte Dr. J. Georges Youssef, der leitende Prüfarzt, der als Leiter der akademischen Lungenheilkunde am Houston Methodist Hospital und als Assistenzprofessor für klinische Medizin am Weill Cornell Medical College tätig ist. "Diese neuesten Daten sind ermutigend und werden uns an der Front bei der Behandlung der kränksten COVID-Patienten helfen und möglicherweise neue Behandlungsmöglichkeiten und -strategien bieten." Diese Ein-Jahres-Ergebnisse stehen im Einklang mit den erhöhten Chancen auf ein 60-Tage-Überleben, die in den zuvor berichteten Ergebnissen der randomisierten kontrollierten Phase-2b/3-Studie mit ZYESAMI festgestellt wurden. Die US-Arzneimittelbehörde FDA prüft nach wie vor die Zulassung von ZYESAMI für die Notfallbehandlung von Patienten mit kritischem Covid-19 mit Atemstillstand.
Relief Reports that its U.S. Collaboration Partner has Announced Improved Survival at One Year in Highly Comorbid COVID-19 Patients Treated with ZYESAMITM (RLF-100TM/aviptadil)
Geneva, Switzerland, September 28, 2021 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that the parent company of its U.S. collaboration partner, NRx Pharmaceuticals, Inc., (Nasdaq: NRXP) (“NRx”), has issued a press release announcing top line data demonstrating improved outcomes at one year in highly comorbid patients with COVID-19 who were treated with ZYESAMI™ (RLF-100 ™/aviptadil). According to NRx’s press release, in highly comorbid COVID- 19 patients, ZYESAMI™ provided a threefold, statistically significant increase in the likelihood of survival at one year, consistent, according to NRx, with the increased odds of 60-day survival seen in the previously reported results from the phase 2b/3 randomized controlled trial of ZYESAMI™ (RLF-100 ™/aviptadil). The related NRx press release can be accessed through the following link.
ABOUT RELIEF Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate, RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief's recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow us on LinkedIn.
Ad hoc announcement pursuant to Art. 53 LR 2
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Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG. Such statements involve certain known and unknown risks, uncertainties and other factors, including (i) whether aviptadil will be determined by regulatory authorities to be safe and effective as a treatment for highly comorbid patients with COVID-19, (ii) whether aviptadil will ever be approved in the U.S., the U.K., or the E.U. for the treatment of respiratory failure in patients with COVID-19 and (iii) those risks discussed in RELIEF THERAPEUTICS Holding AG's press releases and filings with the SIX, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and do not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.