Cestode Infections

First Wave BioPharma to advance GI development pipeline with the expected addition of Phase 3 Latiglutenase celiac disease program and Phase 2 clinical programs built around Capeserod and AdrulipaseBOCA RATON, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has entered a non-binding term sheet to sell its Niclosamide program for the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and related conditions to an undisclosed biopharmaceutical company (the “Proposed Transaction”). The Proposed Transaction will enable First Wave BioPharma to focus its development resources on its three late-stage clinical programs: Capeserod, a selective 5-HT4 receptor partial agonist licensed from Sanofi; Adrulipase, a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency (EPI); and, after the closing of the recently announced potential business combination with ImmunogenX, Latiglutenase, a Phase 3-ready oral biotherapeutic for celiac disease. The non-binding term sheet includes a low seven-figure upfront payment to First Wave BioPharma for rights to Niclosamide, as well as economics related to future milestones and royalties. The transaction is expected to close in the first half of 2024. Additional details of the transaction will be disclosed upon finalization and execution of the definitive agreement. Upon execution of the definitive agreement, the completion of the transaction will be subject to, among other matters, satisfaction of the conditions negotiated therein, the buyer having secured adequate financing, and receipt of all third party (including governmental) approvals, licenses, consents, and clearances, as and when applicable. “This is a very exciting time in the evolution of First Wave BioPharma as we have recently reinvigorated our GI-focused clinical development pipeline with Phase 2-ready Capeserod from Sanofi and the pending addition of Phase 3-ready Latiglutenase,” stated James Sapirstein, President and CEO of First Wave BioPharma. “We plan to rapidly advance these programs in 2024 given the significant potential of each to address GI conditions for which no effective therapies currently exist. As a result, we made the strategic decision to streamline our development pipeline and are pleased to have entered a non-binding term sheet for Niclosamide, which has the potential to infuse First Wave with additional, non-dilutive capital.” Niclosamide is a prescription, non-systemic, small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections and has been safely used on millions of patients. The drug is a potential non-steroidal anti-inflammatory therapy for the treatment of mild-to-moderate inflammatory bowel diseases (IBD). First Wave BioPharma had previously conducted Phase 2 trials with niclosamide for the treatment of ulcerative proctitis/proctosigmoiditis (the most prevalent form of ulcerative colitis) and for the treatment of COVID gastrointestinal infections. The Company also has a Phase 2 open-IND for the treatment of immune checkpoint inhibitor-associated colitis and diarrhea in patients with metastatic cancer. Intellectual property for niclosamide formulations governing composition of matter and methods of use extends beyond 2040. About First Wave BioPharma, Inc. First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple late-stage clinical stage programs, including Capeserod, a selective 5-HT4 receptor partial agonist which First Wave is developing for gastrointestinal (GI) indications; the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; and it is anticipated that the Company will soon acquire Latiglutenase, a targeted, oral first-in-class biotherapeutic for celiac disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information visit www.firstwavebio.com. Forward-Looking Statements This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether a definitive agreement for the Proposed Transaction or a transaction with ImmunogenX and any concurrent financing or licensing transaction will be entered into; whether such transactions, or any other contemplated transaction, may be completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the benefits of the Proposed Transaction described herein; the Company’s ability to integrate the assets and commercial operations contemplated to be acquired from ImmunogenX into the Company’s business; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information:First Wave BioPharma, Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561) 589-7020info@firstwavebio.com Media contact:Tiberend Strategic Advisors, Inc.David Schemelia(609) 468-9325dschemelia@tiberend.com

TOKYO, May 25, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it has committed to supporting the 3rd phase of the Global Health Innovative Technology Fund (GHIT Fund), together with a cross-sector group of funding partners. The cross-sector group has committed over US$200 million to the GHIT Fund. Furthermore, we have contributed to the GHIT Fund for three consecutive terms since the inception of the GHIT Fund. The GHIT Fund launched in 2013 to leverage Japanese expertise and capability for life-saving health innovations, including drugs, vaccines and diagnostics, to combat infectious diseases including tuberculosis, malaria, neglected tropical diseases (NTDs)*1 prevalent in the world's poorest countries. A public interest corporation registered in Japan, the GHIT Fund is the first international public-private partnership fund (PPP) between the Japanese Government: Ministry of Foreign Affairs, Ministry of Health, Labor and Welfare, private sector, the Bill & Melinda Gates Foundation, the Wellcome and the United Nations Development Programme. The GHIT Fund has invested about 29.1 billion yen to support approximately 115 projects over the last ten years. The GHIT Fund engages in direct and effective activities, such as the establishment of a public-private partnership mechanism and launching R&D projects utilizing Japanese drug discovery technologies, innovations and investment in diagnostics development. "Astellas is working to solve issues of Access to Health (ATH) through the GHIT Fund which Astellas has been participating in since the 1st phase of the GHIT Fund and is participating in a GHIT-funded consortium*² that aims to develop a potential new pediatric treatment option for schistosomiasis in preschool-aged children." said Naoki Okamura, President and CEO of Astellas. "Astellas is contributing to this development by leveraging our formulation technologies and know-how. In addition, we have contributed to malaria research in collaboration with partners to solve issues of ATH since 2017." *1: About Neglected Tropical Diseases (NTDs) According to the World Health Organization (WHO), Neglected Tropical Diseases (NTDs) are a diverse group of communicable diseases that prevail in tropical and subtropical conditions and affect more than 1.6 billion people, costing developing economies billions of dollars every year. They mainly affect populations living in poverty, without adequate sanitation and in close contact with infectious vectors and domestic animals and livestock. NTDs are a group of 20 infectious diseases – Buruli ulcer, Chagas disease, Dengue/Chikungunya, Dracunculiasis (guinea-worm disease), Echinococcosis, Foodborne trematodiases, Human African trypanosomiasis (sleeping sickness), Leishmaniasis, Leprosy (Hansen's disease), Lymphatic filariasis, Mycetoma, Onchocerciasis (river blindness), Rabies, Scabies and other ectoparasitoses, Schistosomiasis, Soil-transmitted helminthiases, Snakebite envenoming, Taeniasis/Cysticercosis, Trachoma, Yaws (Endemic treponematoses) . *2: Schistosomiasis and consortium of pediatric formulation for praziquantel Schistosomiasis is one of the most prevalent parasitic diseases in tropical countries, mainly in sub-Saharan Africa. The disease has a particularly high incidence rate among children. The existing "gold standard" treatment for schistosomiasis is praziquantel. However, one challenge is that praziquantel tablets are difficult to administer to preschool-aged children, including infants and toddlers, mainly due to their large size and the drug's bitter taste. Together with a consortium of partners, Astellas has contributed to developing a potential new pediatric treatment option, arpraziquantel, for schistosomiasis in preschool-aged children. Derived from praziquantel, arpraziquantel is a small orally dispersible tablet, with reduction of bitterness. The new formulation was initially developed by Astellas. Arpraziquantel can be manufactured using simple production technology, while holding down production costs, and the tablets are stable even in the hot and humid environment of tropical areas. Astellas has transferred the technology and expertise needed to develop it to a consortium partner in Brazil, thereby helping to build local pharmaceutical manufacturing capabilities. In December 2022, EMA (European Medicines Agency) has validated the regulatory application for arpraziquantel and has started its review process. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. SOURCE Astellas Pharma Inc.

BOCA RATON, Fla., Aug. 12, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (“AzurRx” or the “Company”) (NASDAQ: AZRX), a company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed enrollment of the initial cohort into Part 1 of its ongoing RESERVOIR Phase 2 clinical trial evaluating FW-1022 as a treatment for COVID-19-related gastrointestinal (GI) infections. FW-1022 is a proprietary oral tablet formulation of micronized niclosamide for the treatment of COVID-19-related GI infections. Once all patients in this cohort complete their full two weeks of treatment, the trial’s Data Monitoring Committee (DMC) will review the safety data. Successful DMC review will then trigger enrollment into Part 2 of the trial, focused on demonstrating efficacy and extending safety observations. James Sapirstein, President and CEO of AzurRx, stated, “Completion of enrollment in the first part of our Phase 2 RESERVOIR clinical trial is an important step in our plan to develop niclosamide as a potential treatment for COVID-19 related GI infection. Despite the availability of vaccines, COVID-19 continues to infect people at an alarming rate due to the emergence of more contagious variants. Ultimately, it is our belief that therapeutic solutions will be needed to truly put an end to this pandemic. We believe that niclosamide could play an important role on this front and we look forward to reporting topline results from the RESERVOIR trial in the first quarter of 2022.” The RESERVOIR clinical trial is designed as a two-part, two-arm, placebo-controlled Phase 2 study. The trial’s primary objectives are to confirm the safety of FW-1022 in the treatment of patients with COVID-19-related GI infections and to evaluate its efficacy in clearing SARS-CoV-2 (SARS2), the virus that causes COVID-19, from the GI tract. The primary efficacy measure of the RESERVOIR trial is the rate of fecal SARS2 clearance (stool sample) assessed by PCR, comparing the niclosamide arm to the placebo arm for up to six weeks. These long-term observation data could indicate that niclosamide treatment has the potential to improve “long haul” COVID-19 symptoms. James Pennington, M.D., Chief Medical Officer of AzurRx, commented, “Physicians continue to report that the GI infections caused by COVID-19 remain an underappreciated aspect of the disease, even though these symptoms impact almost 20 percent of COVID-19 patients. We believe our micronized oral niclosamide therapy has the potential to target the SARS2 virus directly in the gastrointestinal tract, where research suggests the virus often hides, replicates and causes illness long after the initial infection.” About Phase 2 RESERVOIR Clinical TrialThe Phase 2 RESERVOIR clinical trial is a two-part, two-arm, placebo-controlled study examining the safety and efficacy of niclosamide in patients with COVID-19 Gastrointestinal Infection. The two primary objectives of this trial are to confirm the safety of niclosamide in treatment of patients with COVID-19 GI infection, and to demonstrate efficacy in clearing the SARS-CoV-2 (SARS2) virus from the GI tract. Part 1 of the trial will study 9 to 18 patients with COVID-19 and GI positive stools for SARS2. Patients will be treated for 14 days and observed closely for any signs of safety issues. A Data Monitoring Committee will then review the safety profile and if niclosamide is well-tolerated, the trial will move on to Part 2. Part 2 will be conducted in outpatients with COVID-19 and PCR positive stools for SARS2. Patients will be randomized to either niclosamide 400 mg tablets, three times a day, or to placebo tablets, three times a day. After 14 days of treatment, patients will be taken off study drugs and remain on study observation for up to 6 weeks. The efficacy endpoint is analyzed by time to clearance from stools of SARS2, comparing the niclosamide arm to the placebo arm. Long term observation will also be important to indicate whether niclosamide treatment might improve ‘long haul’ COVID-19 symptoms. Additional information about the RESERVOIR trial can be found at and on ClinicalTrials.gov. About COVID-19 Gastrointestinal InfectionsGastrointestinal infection symptoms (severe diarrhea, vomiting and abdominal pain) have been reported in approximately 18% of COVID-19 cases.1 Of the 33 million individuals who are reported to have contracted COVID-19 in the U.S.,2 this would translate into 6 million patients having GI infection. Of the 165 million cases globally, it would translate into almost 30 million patients. Furthermore, approximately 10% of patients who were infected with COVID have persistent symptoms months after their initial diagnosis.3 Approximately 86% of these COVID “long haulers” are reported to have GI infection symptoms, with 60% continuing to have diarrhea months after their initial infection.4 There is some evidence to support the view that the GI tract is a possible reservoir for recurrence and fecal spread of the SARS-CoV-2 virus as ACE-2, the entry receptor for COVID-19, is highly expressed on GI cells. There currently is no targeted treatment for COVID-19 GI infections. About NiclosamideNiclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties. There remains an urgent need to develop new medicines that can be manufactured at large scale quickly to treat COVID-19. Niclosamide was recently identified by the Institut Pasteur Korea as a potent inhibitor of SARS-CoV-2, the virus causing COVID-19, with potency 40X greater than remdesivir.5 Additionally, emerging evidence confirms the severe GI-related complications of COVID-19 and potential fecal spread of the virus. The Company’s clinical trials may establish that patients treated with an oral and non-systemic niclosamide formulation that delivers high local GI concentrations have decreased viral load and GI-associated symptoms of COVID-19. Importantly, the manufacturing process for niclosamide can be scaled up to supply large populations quickly. About AzurRx BioPharma, Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of two gut-restricted GI assets in three clinical indications. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a small molecule with anti-viral and anti-inflammatory properties: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for Grade 1 and Grade 2 Immune Checkpoint Inhibitor-associated colitis and diarrhea in advanced oncology patients. The Company is headquartered in Boca Raton, Florida with clinical operations in Hayward, California. For more information visit . Forward-Looking StatementThis press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information:AzurRx BioPharma, Inc.777 Yamato Road, Suite 502Boca Raton, FL 33431Phone: (561) 589-7020info@azurrx.com Media contact:Tiberend Strategic Advisors, Inc.Johanna Bennett / David Schemelia(212) 375-2665 / (609) 468-9325jbennett@tiberend.com / dschemelia@tiberend.com References:1Gut Journal: Vol 69, Issue 6: 2020; JAMA Network: Vol 3, Issue 6: 2020; Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; Cheung Gastroenterology: Vol. 159, Issue 1: 20202 New York Times. (7/1/21)  Rubin, R. “As their numbers grow, COVID-19 “Long Haulers” Stump Experts”. September 23, 2020.4 Davis, et al. “Characterizing Long Covid in an International Cohort: 7 Months of Symptoms and their Impact”.  Jeon S, Ko M, Lee J, Choi I, Byun SY, Park S, Shum D, Kim S. 2020. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Antimicrob Agents Chemother 64:e00819-20. .