{"id":399982,"date":"2020-12-15T09:03:20","date_gmt":"2020-12-15T14:03:20","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=399982"},"modified":"2020-12-15T09:03:20","modified_gmt":"2020-12-15T14:03:20","slug":"tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/","title":{"rendered":"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial<\/b><\/p>\n<p class=\"bwalignc\"><i>Phase 1b Dosing of Voriconazole Inhalation Powder in asthma patients to evaluate safe dosing in patients with hyperreactive airways for direct-to-lung delivery of voriconazole for the treatment or prevention of Invasive Pulmonary Aspergillosis (IPA)<\/i><\/p>\n<p class=\"bwalignc\"><i>Asthma patients with hyperreactive airways represent a large proportion of patients with IPA <\/i><\/p>\n<p>AUSTIN, Texas&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nTFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of voriconazole (NCT #04576325), which is generally considered to be the most effective antifungal drug for treatment of Aspergillosis infections.\n<\/p>\n<p>\nPatients with asthma, and a portion of patients with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD), have hyperreactive airways where bronchoconstriction can be triggered following administration of drugs by inhalation. These patient populations are also susceptible to Invasive Pulmonary Aspergillosis infections due to impaired mucociliary clearance, which allows aspergillus spores to become trapped and grow in mucus that builds up in their lungs.\n<\/p>\n<p>\nTFF Pharmaceuticals is conducting this Phase 1b clinical trial of Voriconazole Inhalation Powder in patients with asthma to assess the safety, pharmacokinetics, and induction of bronchospasm. Drugs for treatment of pulmonary infections can be associated with induction of bronchospasm and require bronchodilator pretreatment for safe administration. Treatment of Voriconazole Inhalation Powder without induction of bronchospasm would allow for treatment of patients with IPA that have hyperreactive airway disease comorbidities to proceed without bronchodilator pretreatment.\n<\/p>\n<p>\n\u201cThe treatment of asthma patients in this study will test the safety and pharmacokinetics in patients with airway hyperresponsiveness, and will expand the potential patient population to help speed enrollment in our pivotal trials for the treatment of IPA with Voriconazole Inhalation Powder,\u201d stated Glenn Mattes, President and CEO of TFF Pharmaceuticals. \u201cThis study will also help us determine if there are differences in drug uptake in patients with compromised lungs, compared to healthy subjects.\u201d\n<\/p>\n<p>\nTFF Pharmaceuticals is advancing development of Voriconazole Inhalation Powder towards a pivotal Phase 2 study to assess the efficacy of the dry powder formulation for the treatment of IPA. Previously, TFF reported that repeated dosing of Voriconazole Inhalation Powder twice daily for 7 days in healthy normal volunteers was well tolerated at doses up to 80 mg with no clinically significant adverse findings, including changes in pulmonary function. The current study is designed to assess the safety and tolerability of 40 and 80 mg doses in asthma patients with hyperreactive airways. Administration of the inhaled voriconazole to IPA patients at 40 mg doses was previously reported to be well tolerated.\n<\/p>\n<p>\nVoriconazole is recommended as the first line treatment for IPA according to the Infectious Disease Society (IDSA) &#8211; Practice Guidelines for the Diagnosis and Management of Aspergillosis (2016), but voriconazole is associated with significant drug-drug interactions and toxicities. Delivery of voriconazole directly to the lung may allow for a product that has greater efficacy than orally administered voriconazole and that has improved safety through reduced systemic toxicities and reduced drug-drug interactions.\n<\/p>\n<p>\nTFF Pharmaceuticals\u2019 proprietary Thin Film Freezing technology platform allows the reformulation of voriconazole into dry powder particles with properties believed to be ideally suited for inhalation delivery. In addition to voriconazole, TFF is also developing dry powder formulations of tacrolimus to prevent lung transplant rejection and niclosamide to treat COVID-19 (SARS-CoV2) infections.\n<\/p>\n<p><b>About TFF Pharmaceuticals\u2019 Thin Film Freezing technology platform<\/b><\/p>\n<p>\nTFF Pharmaceuticals\u2019 Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a \u201cBrittle Matrix Particle,\u201d which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.\n<\/p>\n<p><b>About TFF Pharmaceuticals<\/b><\/p>\n<p>\nTFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company\u2019s website at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftffpharma.com&amp;esheet=52348793&amp;newsitemid=20201215005649&amp;lan=en-US&amp;anchor=https%3A%2F%2Ftffpharma.com&amp;index=1&amp;md5=3644738b1ed83addbe89f120586815fe\">https:\/\/tffpharma.com<\/a>.\n<\/p>\n<p><b>SAFE HARBOR <\/b><\/p>\n<p>\nThis press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company\u2019s TFF platform and its dry powder versions of voriconazole and the Company\u2019s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of voriconazole, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) those other risks disclosed in the section \u201cRisk Factors\u201d included in the Company\u2019s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201215005649r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20201215005649\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20201215005649\/en\/<\/a><\/span><\/p>\n<p><b>Company Contacts:<br \/>\n<\/b><br \/>Glenn Mattes<br \/>\n<br \/>President and CEO<br \/>\n<br \/>TFF Pharmaceuticals, Inc<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:gmattes@tffpharma.com\">gmattes@tffpharma.com<br \/>\n<\/a><br \/>737-802-1973\n<\/p>\n<p>\nKirk Coleman<br \/>\n<br \/>Chief Financial Officer<br \/>\n<br \/>TFF Pharmaceuticals, Inc.<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:kcoleman@tffpharma.com\">kcoleman@tffpharma.com<br \/>\n<\/a><br \/>817-989-6358\n<\/p>\n<p><b>Investor Relations and Media Contact:<br \/>\n<\/b><br \/>Paul Sagan<br \/>\n<br \/>LaVoieHealthScience<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:psagan@lavoiehealthscience.com\">psagan@lavoiehealthscience.com<br \/>\n<\/a><br \/>617-865-0041\n<\/p>\n<p><b>KEYWORDS:<\/b> Texas United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health Other Science Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201215005649\/en\/757396\/3\/TFF_Pharmaceuticals_Logo__JPEG.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial Phase 1b Dosing of Voriconazole Inhalation Powder in asthma patients to evaluate safe dosing in patients with hyperreactive airways for direct-to-lung delivery of voriconazole for the treatment or prevention of Invasive Pulmonary Aspergillosis (IPA) Asthma patients with hyperreactive airways represent a large proportion of patients with IPA AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211; TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-399982","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial Phase 1b Dosing of Voriconazole Inhalation Powder in asthma patients to evaluate safe dosing in patients with hyperreactive airways for direct-to-lung delivery of voriconazole for the treatment or prevention of Invasive Pulmonary Aspergillosis (IPA) Asthma patients with hyperreactive airways represent a large proportion of patients with IPA AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211; TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of &hellip; Continue reading &quot;TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-15T14:03:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201215005649r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial\",\"datePublished\":\"2020-12-15T14:03:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\\\/\"},\"wordCount\":1149,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20201215005649r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\\\/\",\"name\":\"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/","og_locale":"en_US","og_type":"article","og_title":"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial - Market Newsdesk","og_description":"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial Phase 1b Dosing of Voriconazole Inhalation Powder in asthma patients to evaluate safe dosing in patients with hyperreactive airways for direct-to-lung delivery of voriconazole for the treatment or prevention of Invasive Pulmonary Aspergillosis (IPA) Asthma patients with hyperreactive airways represent a large proportion of patients with IPA AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211; TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of &hellip; Continue reading \"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-15T14:03:20+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201215005649r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial","datePublished":"2020-12-15T14:03:20+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/"},"wordCount":1149,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201215005649r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/tff-pharmaceuticals-announces-first-dosing-of-asthma-patients-with-voriconazole-inhalation-powder-in-a-phase-1b-clinical-trial\/","name":"TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial - 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