Rhinitis

OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine. OX640 is based on Orexo´s proprietary drug delivery platform, AmorphOX®, and has demonstrated positive data in a phase 1 clinical study in healthy volunteers. The new study will investigate the performance of OX640 in participants with allergic rhinitis. UPPSALA, Sweden, Oct. 25, 2024 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine, in a new study in subjects with allergic rhinitis (hay fever). The study will be completed during 2024 with results available early in 2025. Following the positive results from the phase 1 clinical study, OX640-001, where OX640 showed absorption of epinephrine and effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector, Orexo now advances the development of OX640. In the new study, OX640-002, the epinephrine absorption from OX640 will be investigated in participants with and without allergic symptoms in the nose. As patients may experience allergic symptoms in the nose during anaphylaxis, it is critical to understand the absorption of epinephrine from Orexo's unique powder formulation under these conditions. The study is a cross-over study in 30 participants with allergic rhinitis and involves four treatment periods. In one of the periods, a small dose of an allergen will be sprayed into the nose of the participants to trigger an allergic reaction before being treated with OX640. This will be compared with absorption of epinephrine from OX640 without the allergen, and a commercial intramuscular epinephrine product. The fourth period will be used to document dose proportionality of OX640. In addition to the absorption of epinephrine, effects on blood pressure and heart rate will be measured as relevant parameters to understand the effect of OX640 in case of an anaphylaxis. Robert Rönn, SVP and Head of R&D, said: "Anaphylaxis is a serious and life-threatening condition, making it essential to ensure that OX640 remains effective even in the presence of nasal allergic symptoms. The study addresses key development and regulatory requirements and is an important step in advancing the project towards regulatory approval. The performance of OX640 under allergic rhinitis conditions has also been requested in many discussions with health care providers and with potential partners." The study is expected to cost SEK 11 million. Most of these costs will be recognized in 2024 and are included in the communicated financial outlook for 2024. For further information: Robert Rönn, SVP and Head of R&D Lena Wange, IR & Communications Director Nikolaj Sørensen, President and CEO Tel: +46 (0)18 780 88 00 E-mail: [email protected] About AmorphOX ® Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. About OX640 OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine. The product is based on Orexo´s proprietary drug delivery platform AmorphOX providing rapid and extensive systemic drug absorption after nasal administration as well as excellent physical and chemical stability. Thanks to its unique properties, OX640 has the potential to provide allergic patients with a needle-free, convenient, and rapidly acting allergy rescue product that also has long shelf-life and allows for flexible storage, both in hot and cold temperatures. About OX640-001 OX640-001 is a randomised sequence, single-centre, open label, 5-period crossover, phase 1 comparative bioavailability study with the primary objective to determine the relative bioavailability and absorption characteristics of four investigational formulations of OX640 versus an intramuscular auto-injector of epinephrine. About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2022 amounted to SEK 624 million, and the number of employees to 126. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US. For more information about Orexo please visit, . You can also follow Orexo on X, LinkedIn, and YouTube. The information was submitted for publication at 3 pm CET on October 25, 2024. This information was brought to you by Cision . 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SAN DIEGO, Oct. 24, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today that seven abstracts will be featured tomorrow, Friday, October 25 at the 2024 ACAAI Annual Scientific Meeting taking place in Boston, Massachusetts. The posters highlight a wide range of studies focused on intranasal epinephrine administration, including cardiovascular safety, human factor study of carrying two devices at all times, and real-world administration data in pediatric patients. “The research being presented at the ACAAI Annual Scientific Meeting is part of the extensive body of knowledge that ARS has contributed on epinephrine administration through our comprehensive clinical research,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals, the developer of neffy® (epinephrine nasal spray) the first and only needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). “Our studies have brought forward valuable new data that demonstrates nasal spray delivery of epinephrine is not only successfully administered in real-world situations, but it also provides valuable insights into the broader understanding of how epinephrine works in the body. Our research contributes to the allergy community’s knowledge of both neffy’s performance and expands scientific findings and hypothesis, helping us advance treatment options for patients with severe allergies.” The complete list of ARS Pharmaceuticals’ poster presentations is below. Full posters can be viewed online here. Poster Presentation #1Time:3:15-3:30pm EDTTitle:“Cardiovascular Safety of Intramuscular and Intranasal Epinephrine Administration”Authors: Jay A. Lieberman, Richard D Wainford, Carlos A. Camargo Jr, Thomas B Casale, Richard Lowenthal, Sarina Tanimoto Abstract ID:8064ePoster ID: R235 Poster Presentation #2Time:3:30-3:45pm EDTTitle:“Blood Pressure And Pulse Rate Increases, Without Concomitant Epinephrine Increases, During Acute Allergic Reactions”Authors: Jonathan M. Spergel, Motohiro Ebisawa, Anne K. Ellis, Thomas B. Casale, John Oppenheimer, Carlos A. Camargo, Jr., Aikaterini Anagnostou, Richard Lowenthal, Sarina TanimotoAbstract ID:8065ePoster ID: R236 Poster Presentation #3Time:3:45-4:00pm EDTTitle:“Successful Administration of ARS-1 (Intranasal Epinephrine) when Provided with a Two-Dose Carrying Case-Human Factor Study”Authors: Vivian Hernandez-Trujillo, Joel Brooks, Raffi Tachdjian, Brian Dorsey, Richard Lowenthal, Sarina TanimotoAbstract ID:8066ePoster ID: R237 Poster Presentation #4Time:4:00-4:15pm EDTTitle:“Significant Differences in Pharmacokinetic Profiles Among Epinephrine Products-What is the Mechanism for Efficacy?”Authors: Matthew Greenhawt, Jay A Lieberman, Thomas B. Casale, Anna Nowak-Wegrzyn, Jonathan M. Spergel, Richard Lowenthal, Sarina TanimotoAbstract ID:8067ePoster ID: R238 Poster Presentation #5Time:4:15-4:30pm EDTTitle:“Pharmacokinetics And Pharmacodynamics Following Repeat Dosing of ARS-1 versus Intramuscular Injection During Allergic Rhinitis”Authors: John Oppenheimer, Thomas Casale, Jonathan Spergel, David Bernstein, Carlos A. Camargo, Jr., Anne Ellis, Richard Lowenthal, Sarina TanimotoAbstract ID:8068ePoster ID: R239 Poster Presentation #6Time:4:30-4:45pm EDTTitle:“ARS-1 Development, From Pharmacokinetics and Pharmacodynamics to Real-World Data in Pediatric Food Allergy Patients”Authors: Motohiro Ebisawa, David M. Fleischer, H Henry Li, Michael Kaliner, Richard Lockey, Neetu Talreja, Richard Lowenthal, Sarina TanimotoAbstract ID:8069ePoster ID: R240 Poster Presentation #7Time:4:45-5:00pm EDTTitle:“HCP Interest in ARS-1, a Self-Administered Intranasal Epinephrine Device”Authors: Nicole Chase, Autumn Burnette, Daniel Soteres, Justin Greiwe, Harris Kaplan, Ayman KafalAbstract ID:8070ePoster ID: R241 About Type I Allergic Reactions including AnaphylaxisType I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions due to food, venom or insect stings. Of those, only 3.3 million currently have an active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency. About neffy® neffy® is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis. INDICATION AND IMPORTANT SAFETY INFORMATION FOR neffy (epinephrine nasal spray) INDICATION neffy 2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater. IMPORTANT SAFETY INFORMATION It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose. neffy is for use in the nose only. Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required. Absorption of neffy may be affected by underlying structural or anatomical nasal conditions. Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics. The presence of a sulfite in neffy should not deter use. neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women. Adverse reactions to neffy may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting. These are not all of the possible side effects of neffy. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information on neffy, please see Full Prescribing Information at www.neffy.com. About ARS Pharmaceuticals, Inc.ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the US for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com. Forward-Looking StatementsStatements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include but are not limited to: the significance of the results from ARS Pharmaceuticals’ studies; the needle-free profile of neffy potentially increasing the likelihood that patients may both carry and administer epinephrine; the potential market and demand for neffy; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “can,” “could,” “may,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: the ability to obtain and maintain regulatory approval for neffy; potential safety and other complications from neffy; the labelling for neffy in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing neffy; the potential for payors to delay, limit or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 6, 2024. This and other documents ARS Pharmaceuticals files with the SEC can also be accessed on ARS Pharmaceuticals’ website at ir.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab. ARS Investor Contact:Justin ChakmaARS Pharmaceuticalsjustinc@ars-pharma.com Alex StrausTHRUST Strategic Communicationsalex@thrustsc.com ARS Media Contact:Christy CurranSam Brown Inc.615.414.8668christycurran@sambrown.com

Sublingual (SL) formulation of ‘1104 achieved comparable responses to subcutaneous (SQ) and intravenous (IV) injections‘1104 SC and SL dosing options create opportunities for highly differentiated product profiles in eosinophilic esophagitis (EoE) and other allergic diseases versus currently available therapiesData provides additional validation for the differentiated upstream mechanism of action (MOA) of ‘1104, already confirmed in the clinic GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics Limited (“Revolo”) today announced new preclinical data demonstrating the potential of its lead allergic-disease treatment candidate, ‘1104, as a SL formulation. The data shows that when administered sublingually via a dissolvable tablet in a lung model of allergic disease, ‘1104 achieves comparable positive results across multiple inflammatory immune cells and other markers of allergic inflammation to those seen with SQ or IV injections of ‘1104. Additionally, the data continues to demonstrate the differentiated upstream MOA of ‘1104, restoring immune homeostasis by impacting both the effector and regulatory arms of the immune system with a persistence of effect for multiple weeks. Specifically, SL dosing of ‘1104 resulted in reduced inflammatory cell infiltration, including eosinophils and neutrophils, comparable to SQ and IV routes. SL dosing of ‘1104 also led to a reduction of key T2 cytokines and allergen specific immunoglobulin (Ig)E, similar to reductions seen with SQ and IV administration. “If successfully translated to the clinic, a sublingual option could represent a breakthrough in the treatment landscape for people living with EoE and other allergic diseases,” said Kari Brown, M.D., Chief Medical Officer at Revolo. “The differentiated upstream MOA by which ‘1104 acts, alongside a favorable safety profile across multiple Phase 1-2 clinical studies and its potential flexibility in route of administration, highlights its potential use as a future first-line therapy.” There is a strong need for additional treatment options for patients with EoE and other allergic diseases. Current therapeutics for EoE, the lead indication for ‘1104, include chronic subcutaneous monoclonal antibodies and oral options with significant safety considerations. Woody Bryan, Ph.D., President and Chief Executive Officer of Revolo, added, “Following data announced earlier this year, which supports the development of a subcutaneous formulation of ‘1104, these positive oral results provide Revolo with an exciting path forward. As we look to the future, we will prioritize the SQ formulation of ‘1104, with plans to initiate a new Phase 2 study in EoE in 2025 and potentially atopic dermatitis. However, we will continue to gather data on the SL formulation in parallel to inform our future strategy, including ongoing discussions with strategic partners. Our goal is to provide people with chronic allergic conditions a new effective and convenient treatment option without the burden of limiting side effects.” About ‘1104‘1104 is a first-in-class peptide that is involved in restoring immune homeostasis, uniquely impacting both the regulatory and effector arms of the immune system. Revolo has recently advanced ‘1104 through a Phase 2a trial in eosinophilic esophagitis (EoE) and a clinical mapping study in patients with allergic rhinitis, while exploring its potential for other allergic diseases. Revolo is planning to advance a commercially differentiated subcutaneous dosage form into clinical studies for EoE and other type 2 allergic conditions while advancing development of a sublingual formulation. About Revolo BiotherapeuticsRevolo is developing therapies that work upstream in the immune cascade for the treatment of allergic and autoimmune diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1104 and ‘1805, a peptide and a protein respectively, restore immune homeostasis to prevent the chronic pro-inflammatory immune response that results in allergic or autoimmune disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple allergic and autoimmune diseases. For further information, please visit www.revolobio.com. Company ContactWoody Bryan, Ph.D.President and CEOwbryan@revolobio.com Media ContactMichael RubensteinLifeSci Communications+1 561-289-7981mrubenstein@lifescicomms.com