Ritonavir

WATERTOWN, Mass.--(BUSINESS WIRE)--Dec. 24, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that the United States District Court of Massachusetts (“the Court”) has issued a ruling on a summary judgment motion filed by Pfizer, Inc. in connection with Enanta’s patent infringement lawsuit seeking damages for infringement of U.S. Patent No. 11,358,953 (“the ’953 Patent”) in the manufacture, use and sale of Pfizer’s COVID-19 antiviral, Paxlovid™ (nirmatrelvir tablets; ritonavir tablets). The Court issued a summary judgment decision granting Pfizer’s motion that the ‘953 Patent is invalid. In its decision, the Court also denied Enanta’s partial motion for summary judgment of infringement as moot in light of its allowance of summary judgment on invalidity. Enanta plans to appeal the decision to the Court of Appeals for the Federal Circuit. "The U.S. patent system and its protection of important innovations have enabled the robust development of new medicines and spurred growth in the biotechnology industry. We are proud of the impact our strong history of drug discovery work with protease inhibitors has had on antiviral treatments and the thousands of patients that have been treated with therapies using our patented inventions,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals, Inc. “We are disappointed with the Court’s ruling. We believe strongly in the merits of our case, and, through the appeal process, we will continue to defend our inventions from unlawful infringement.” Enanta maintains its commitment to avoid attempting to impede the production, sale or distribution of Paxlovid. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information. Forward-Looking Statements This press release contains forward-looking statements, including statements with respect to Enanta’s suit against Pfizer, Inc. in the United States District Court for the District of Massachusetts seeking damages for patent infringement. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta is competing to develop intellectual property in areas of small-molecule drug development that are highly competitive; issued patents, including the patent at issue in the Pfizer litigation, could be found invalid or unenforceable if challenged in court and could be costly to defend and be a distraction for Enanta’s senior management and scientific personnel; intellectual property litigation may lead to unfavorable publicity that harms Enanta’s reputation and causes the market price of its common stock to decline; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year ended September 30, 2024 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20241224565771/en/ Media and Investors: Jennifer Viera 617-744-3848 jviera@enanta.com Source: Enanta Pharmaceuticals, Inc.

Investigational agent in development for treatment or prevention of H5N1 Bird Flu Phase 1 dosing completed in healthy volunteers Potent inhibition of drug-resistant and bird flu viruses in vitro In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs Phase 2 study expected to begin in H1 2025 Traws Pharma is expanding its influenza program to address the potential threat of bird flu NEWTOWN, Pa., Dec. 23, 2024 /PRNewswire/ -- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced progress in the development of its investigational one-dose influenza (flu) investigational therapy, tivoxavir marboxil for treatment of H5N1 bird flu. "The spread of avian influenza in wild and domestic animal populations including mammals, brings increasing risk for adaptation to humans and subsequent spread in the population" said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). "Bird flu is an occupational hazard for poultry and dairy workers. With increasing numbers of human infections and recent reports of severe cases, we should be alert to the rising potential for epidemic or pandemic spread of bird flu." "In laboratory testing, tivoxavir marboxil inhibited multiple isolates of highly pathogenic avian influenza H5N1. We evaluated the effects of drug treatment in mice exposed to human H5N1, where the virus was isolated from a dairy worker exposed to infected cattle," said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. "Oral treatment with tivoxavir marboxil after the virus infection resulted in complete survival and lung virus levels below the limit of quantitation1. This result is highly encouraging for future clinical development of tivoxavir marboxil for treating human H5N1 influenza." "Current topline data from our Phase I clinical trial demonstrated safety and tolerability of tivoxavir marboxil, and maintenance of drug levels in blood above the EC90 for longer than 23 days1, with topline data for a higher dose still to come," said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. "In addition, the potential for tivoxavir marboxil as a treatment for H5N1 bird flu was demonstrated in an animal model." Topline Phase 1 Results with Tivoxavir Marboxil The Phase 1 trial was a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of ascending doses for one-time tivoxavir marboxil treatment in healthy, influenza-negative, adult volunteers. No treatment-related adverse events were reported during the Phase 1 study. Current topline data from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 for more than twenty-three days, with topline data for a higher dose still to come. Preclinical studies showed that tivoxavir marboxil demonstrated potent inhibition of drug-resistant influenza viruses, as well as potent inhibition of highly pathogenic bird flu viruses1 both in vitro and in vivo. About H5N1 Bird Flu The virus, also known as Type A H5N1 was detected for the first time in U.S. dairy cattle in March 2024. Since then, bird flu has been confirmed in at least 866 herds in 16 states. More than 60 people in eight states have been infected according to the U.S. Centers for Disease Control and Prevention. Health officials confirmed in December 2024 the first known severe illness in the U.S. caused by bird flu7. The California governor declared a state of emergency as the virus rampages through dairy cattle in that state8. About Tivoxavir Marboxil Seasonal influenza is estimated to represent a multi-billion antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1, with upside potential from pandemic flu outbreaks. Tivoxavir marboxil (also known as AV5124 or TRX-100) was designed as an inhibitor of the highly conserved influenza protein, CAP-dependent endonuclease (CEN). It has demonstrated potent in vitro activity against a range of influenza strains, including the highly pathogenic avian flu, in preclinical studies. The drug candidate's Phase 1 pharmacokinetic (PK) profile in healthy subjects, including the ability to achieve plasma levels that are consistently above the EC90 (as determined in laboratory studies), for more than twenty-three days with higher dose data to come, may enable a single dose prophylaxis regimen. These data, combined with good overall tolerability results in healthy subjects and prevention of lethal influenza in an animal model, support further development of tivoxavir marboxil as a one-time treatment for influenza. Source information: TRAW data on file Flu is burdensome Flu hospitalizations Flu mortality Flu in older adults Avian flu Bird flu CDC California About Traws Pharma, Inc. Antiviral Program Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases. The viral respiratory disease program includes two oral, novel, Phase 1, potentially best-in-class, small molecule drug candidates: tivoxavir marboxil, in development for flu and pandemic flu, targeting the influenza cap-dependent endonuclease (CEN); and ratutrelvir, in development as a COVID treatment, targeting the Mpro (3CL protease), without the need for co-administration of ritonavir. Traws Pharma is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and the regulatory plans for tivoxavir marboxil. The Company has attempted to identify forward-looking statements by terminology including "believes", "estimates", "anticipates", "expects", "plans", "intends", "may", "could", "might", "will", "should", "preliminary", "encouraging", "approximately" or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws' clinical trials, collaborations, market conditions and those discussed under the heading "Risk Factors" in Traws' filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Traws Pharma Contacts: Mark Guerin Traws Pharma, Inc. 267-759-3680 SOURCE Traws Pharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED