Rhinitis

SAN DIEGO, March 12, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the Phase I data of LP-003 (new generation of anti-IgE antibody) at the 2024 American Academy of Dermatology Association annual meeting (2024AAD). The presentation of the poster titled "A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody" by Longbio Pharma marked a significant moment during the conference. Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody Abstract Submission ID: 50484 Presentation Time: Mar 8-12, 2024 Location: Poster Exhibits Center Results: In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into 5 groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 44.6 days to 76.5 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 168 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. Chronic spontaneous urticaria (CSU) stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Despite SoC treatment, the efficacy and duration of relief remain significant challenges for patients and healthcare providers alike. Anti-IgE therapy was approved as a second-line treatment, however, only approximately 40% of patients achieving complete response following 300 mg Omalizumab dosing. Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed. The successful Phase II study of Ligelizumab points a way that anti-IgE antibody with higher IgE affinity and more potent efficacy (FcεRI inhibition) retains the potential to be superior against Omalizumab. In this study, Longbio Pharma developed a new generation of anti-IgE antibody, LP-003, of higher IgE binding affinity, stronger FcεRI inhibition bioactivity, compared to Omalizumab and even Ligelizumab. Meanwhile, LP-003 has a much longer half-life (approximately 45∽76 days) compared to Omalizumab (approximately 17∽20 days). Moreover, a Phase II clinical trial (NCT06228560) of total 200 adult refractory CSU patients, despite up-dosing anti-histamine (H1) treatment, are being enrolled into 5 distinct groups (n=40/group), including three LP-003 treatment groups, one omalizumab treatment group, to provide a head-to-head comparison, and one placebo group. The topline results are expected to be released in early 2025. About LP-003 LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity (FcεRI and FcεRII/CD23 inhibition), off-target binding and animal study (Tox and efficacy) was conducted. LP-003 just accomplished its Phase II study of allergic rhinitis. The current data shows LP-003 has the potential to become a best-in-class treatment. About Longbio Pharma LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and complement diseases, serving patients and society. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Spirair™, an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients, today announced the appointment of Benjamin Bishop as its chief executive officer. The company is developing a novel therapy for symptomatic nasal septal deviation (NSD) that supports and straightens minor deviations in the septum with a bioabsorbable implant. Septal deviation is one of the most common causes of nasal airway obstruction (NAO), a condition that makes it difficult to breathe through the nose. 1 Despite advancements in techniques, treatments and technologies in the otolaryngology (ENT) field broadly, NSD correction has remained stagnant for years. Treatment options for symptomatic NSD have been limited to either over-the-counter medications to alleviate symptoms or invasive surgical techniques to address the structural issues that cause these symptoms. Traditional septoplasty or septorhinoplasty are the most common surgical treatment options for NSD. Septoplasty can require significant time away from work, with approximately 40% of patients requiring two or more weeks off for recovery. 2 “ Our team is partnering with leading ENT advisors and industry veterans to develop minimally invasive solutions that provide strong outcomes and a better experience for their patients,” said Bishop. “ I’m proud to join this team of innovators who are working to add treatment options to physicians’ toolkits to help them continue supporting their patients.” Bishop joins Spirair with two decades of commercial leadership experience across the medical, surgical and aesthetic industries. He has a proven track record for successfully launching disruptive technologies and establishing new markets, playing a key role in developing high-growth companies like Revelle Aesthetics, Revance Therapeutics, and Access Closure. Bishop also led sales and marketing at Arrinex – the company that developed ClariFix ® , an ENT technology for chronic rhinitis – prior to its acquisition by Stryker in 2019. Spirair got its start in the Stanford Biodesign Innovation Fellowship, a program that equips aspiring innovators with a proven, repeatable process to identify important health-related needs, invent novel health technologies to address them, and prepare to implement those products into patient care. Founders James Kintzing, Ph.D. and Brandon McCutcheon, M.D. were co-fellows in the program and identified an opportunity in the ENT space when they discovered the unmet need for a minimally invasive nasal septal deviation correction therapy to help address nasal airway obstruction. “ As an alumna of the Stanford Biodesign Innovation Fellowship myself, I’ve seen firsthand how this program successfully supports groundbreaking ideas in healthcare technology – and Spirair is a shining example of this innovation,” said Kate Garrett, managing partner at Sonder Capital, assistant director of the Stanford Biodesign Innovation Fellowship and chair of Spirair’s board of directors. “ Benjamin Bishop has an outstanding track record as a commercial leader and I’m thrilled to welcome him to Spirair as its chief executive officer as we begin this exciting next stage of growth.” Spirair’s nasal septal deviation therapy is currently being investigated as part of two IRB-approved nonsignificant risk (NSR) U.S. clinical trials. The company expects to begin a Series B fundraising round and initiate its commercialization efforts in 2024. 1 Clark DW, Del Signore AG, Raithatha R, Senior BA. Nasal airway obstruction: Prevalence and anatomic contributors. Ear Nose Throat J. 2018 Jun;97(6):173-176. doi: 10.1177/014556131809700615. PMID: 30036414. 2 Chidambaram A, et al. Anticipated absence from work ('sick leave') following routine ENT surgery: are we giving the correct advice? A postal questionnaire survey. Clin Otolaryngol Allied Sci. 2001 Apr;26(2):104-8. doi: 10.1046/j.1365-2273.2001.00433.x. PMID: 11309049. About Spirair Spirair is an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients by providing strong outcomes and a better patient experience. Spirair is committed to developing new therapies that can easily integrate in any ENT’s treatment algorithms so they can help more of their patients breathe better. Its first product is a novel minimally invasive option for symptomatic NSD that supports and straightens minor deviations in the septal cartilage and can be conveniently and safely performed under local anesthesia in any site of service as part of standard septoplasty techniques. The company got its start through the Stanford Biodesign Innovation Fellowship, a program that equips aspiring innovators with a proven, repeatable process to identify important health-related needs, invent novel health technologies to address them, and prepare to implement those products into patient care.

Significant unmet need with 80-90% of patients with current epinephrine Rx not using as directed, and only ~15% of diagnosed severe Type I allergy population with a current epinephrine prescription Multiple favorable attributes and potential best-in-class pro neffy highlighted at the event Potential for epinephrine market to significantly expand from today due to availability of neffy SAN DIEGO, March 07, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today hosted an investor event highlighting neffy® (epinephrine nasal spray), an investigational new drug, for the treatment of Type I allergic reactions. The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D. “During our neffy Investor Day, we highlighted the substantial unmet need faced by patients suffering from severe allergies, and how current epinephrine treatments, while effective, have limitations – largely stemming from needle-related risks and portability issues,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “Dr. Spergel and Dr. Casale discussed the limitations of today’s needle-based treatments and how a product with neffy’s pro the likelihood that patients will easily carry and confidently administer epinephrine without anxiety or hesitation. We believe we have addressed the deficiencies identified in FDA’s CRL for neffy, and we expect to submit a response early in the second quarter of 2024 and, if approved, look forward to bringing this innovative treatment to patients.” Dr. Jonathan Spergel, M.D., Ph.D., Professor of Pediatrics and Chief of the Allergy Program at Children’s Hospital of Philadelphia, commented, “Epinephrine has been used for more than 100 years and we know that it is an effective treatment to reverse the symptoms of anaphylaxis, yet approximately 40% of patients do not fill their epinephrine prescriptions. Of the patients that do fill their prescription, 80-90% either do not carry or use their treatment as indicated. Prompt administration of epinephrine is the most critical factor that translates to better efficacy, regardless of device. The availability of an additional epinephrine option will help with compliance, especially with respect to children who account for almost half of the population with active prescriptions today.” Multiple Favorable Attributes of neffy’s potential Profile, if approved, Highlighted during Investor Day Effectiveness and Reliability Safety Ease of Use Rapid effects within minutes based on pharmacodynamic response observed even 1 minute after dosing, as well as oral food challenge anaphylaxis and treatment-refractory chronic spontaneous urticaria efficacy data Well-tolerated – mild nasal discomfort (9.7%) and mild headache (6%) are the most frequent adverse events (>5%) Ease of use with 100% of untrained adults and children in human factors studies able to successfully dose neffy 99.999% reliable device with proven use in emergency settings – tens of millions of units sold each year across seven other FDA approved products No needle eliminates risk of needle-related injuries and accidental blood vessel injections Portable – two neffy’s fit easily in your pocket Consistent pharmacokinetic and pharmacodynamic pro the range of approved injection products even for repeat dosing and under challenge conditions such as rhinitis High bioavailability with low 2 mg dose that minimizes risk of overexposure and side effects that mimic anaphylaxis such as vomiting and GI symptoms Ability to dose not interfered by frequently observed anaphylaxis symptoms1such as vomiting (~20%), angioedema of the face, lips, tongue or larynx (~45%) or difficulty breathing (~55%) No meaningful pain or irritation as assessed by formal scales (mean visual analogue scale, or VAS, scores of 5 to 8 out of 100) Positive palatability with no taste or smell 1 Frequency of symptoms observed during anaphylaxis based on an analysis of 4,805 cases reported in peer-reviewed journal publications In September 2023, ARS Pharma announced that the U.S. Food and Drug Administration (“FDA”) issued a Complete Response Letter (“CRL”) regarding its New Drug Application (“NDA”) for neffy. ARS Pharma believes it has successfully addressed the deficiencies identified in the CRL and expects to submit a response early in the second quarter of 2024. Following an expected up to six-month review period, ARS Pharma anticipates an FDA action date and potential launch of neffy in the second half of 2024. The marketing authorization application (“MAA”) for neffy is also under review by the European Medicines Agency (EMA) with a decision expected in the second quarter of 2024. Additional submissions to other foreign regulatory authorities are planned for 2024. Dr. Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of the Allergy & Immunology Division at University of South Florida, added, "To consider recommending a novel epinephrine delivery product to the allergy patients in our clinics, I need to know that the product works, that it is safe and that patients will actually use it during an episode. neffy, if approved, would not only offer a rapid and reliable response in reversing anaphylaxis symptoms, but its benign side effect pro with a portable, easy to use design make this an attractive option for the severe allergy community that is eagerly awaiting a needle-free epinephrine treatment option. I am confident that patients will have a higher likelihood of filling their neffy prescription, and that they will more frequently carry their device and be less hesitant to use neffy shortly after symptom onset.” Eric Karas, ARS Pharma’s Chief Commercial Officer, noted, “Roughly 20 million patients in the U.S. have been formally diagnosed with severe Type 1 allergies. There is a substantial opportunity to penetrate and significantly expand the epinephrine treatment market, starting with the more than six million patients today that either do not fill their epinephrine prescription, do not use their current device at all, or use their device incorrectly. During the Investor Day, we outlined in detail how we expect neffy’s favorable attributes, combined with promotion and population growth, may potentially expand today’s epinephrine market from the approximately five million two-pack autoinjector units sold annually in the U.S. today, to over 14 million two-pack units by 2034. Having a device that is needle-free, easy to carry and easy to use, we expect patients will be more likely to have neffy with them when an allergic reaction occurs and be less hesitant to use the device at symptom onset.” In addition to severe Type I allergic reactions including anaphylaxis, ARS Pharma is actively developing neffy for the treatment of urticaria. In late-February, the Company announced positive clinical data from a Phase 2 trial evaluating neffy in adults with chronic spontaneous urticaria. ARS Pharma plans to initiate an outpatient urticaria study in patients treated with antihistamines who experience frequent acute flares later in 2024, potentially followed by initiation of a single pivotal efficacy study. The webcast replay and accompanying slides from today’s investor event may be accessed through the Events & Presentations page in the Investors & Media section of the Company's website. A replay of the webcast will be archived on the Company’s website for 90 days. About Type I Allergic Reactions including Anaphylaxis Type I severe 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 autoinjectors 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 severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. About Urticaria Urticaria is a skin disorder that causes itchy hives and/or angioedema. Approximately 50% of chronic urticaria cases are non-responsive to first-line antihistamine therapy. These non-responsive patients on stable therapy regimens can experience exacerbations or flares several times a year among acute cases, and even several times a week, including up to three or four emergency room visits, among chronic urticaria cases. About ARS Pharmaceuticals, Inc. ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (also referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit . Forward-Looking Statements Statements 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 potential market, demand and expansion opportunities for neffy; potential benefits and favorable attributes of neffy, if approved, including the likelihood that allergy patients, especially children, as well as caregivers, will choose to carry and dose neffy compared to needle-bearing options; ARS Pharma’s plan to NDA early in the second quarter of 2024, with an anticipated Prescription Drug User Fee Act (“PDUFA”) action date and launch of neffy, if approved, in the second half of 2024; the timing of the EMA’s decision of ARS Pharma’s MAA; the timing of additional submissions to other foreign regulatory authorities; ARS pharma’s plans to initiate an outpatient urticaria study later in 2024, potentially followed by initiation of a single pivotal efficacy study; 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 “anticipate,” “expects,” “plans,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma’s 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; even though the FDA has stated that completion of the repeat-dose study under allergen-induced allergic rhinitis conditions for neffy will sufficiently address the agency’s outstanding questions, there is no guarantee that new issues will not be identified which could delay or prevent the approval of neffy; whether the FDA will view the results from ARS Pharma’s repeat-dose study under allergen-induced allergic rhinitis conditions for neffy as successful and sufficient to support approval; the PDUFA target action date may be further delayed due to various factors outside ARS Pharma’s control; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing neffy; potential for payers 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 Pharma’s ability to protect its intellectual property position; uncertainties related to capital requirements; 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 Pharma’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the Securities and Exchange Commission (“SEC”) on November 9, 2023. This and other documents ARS Pharma files with the SEC can also be accessed on ARS Pharma’s website at ir.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab. The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law. ARS Investor Contacts: Justin Chakma ARS Pharmaceuticals justinc@ars-pharma.com ARS Media Contact: Laura O’Neill Laura.oneill@finnpartners.com