Non-Eosinophilic Asthma

Topline results are expected in the first quarter of 2025 NEW HAVEN, Conn., Oct. 21, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2a trial for the treatment of RCC ("RIVER") and expects to report topline data in the first quarter of 2025. "We are happy to have completed enrollment for our Phase 2a RIVER trial for the treatment of RCC," said Jennifer Good, President and CEO of Trevi Therapeutics. "RCC impacts approximately 2-3 million adults in the U.S. and with no approved treatment options, there is a large unmet need for new therapies that address cough hypersensitivity. We look forward to reporting the topline results for RIVER early next year and building on the positive results we have seen in studying chronic cough in IPF." Phase 2a Trial Design: Refractory Chronic Cough Improvement Via Nal ER (RIVER) The Phase 2a RIVER trial is a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for the treatment of RCC. The trial is being conducted at multiple sites in the United Kingdom and Canada. The primary endpoint of the trial is a mean change in 24-hour cough frequency in the overall population as determined using an objective cough monitor. Based on the screening results, the study will enroll patients into one of two subgroups: 10-19 coughs/hour (moderate 24-hour cough frequency) and ≥20 coughs/hour (high 24-hour cough frequency). The trial will also explore secondary endpoints, including patient-reported outcome measures for cough frequency and severity. The trial was designed to enroll approximately 60 adult patients. About Refractory Chronic Cough (RCC) Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) or where no underlying condition exists. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release (ER)) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not scheduled by the U.S. Drug Enforcement Agency. The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal benefit to patients. Chronic cough affects up to 10% of the adult population, and Haduvio's expansion into RCC has the potential to reach patients suffering from moderate to severe refractory chronic cough. There are also no approved therapies for RCC in the U.S. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's expectation of reporting topline data from Trevi's Phase 2a RIVER trial in the first quarter of 2025. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties regarding the success and timing of Trevi's product candidate development activities, including its ongoing clinical trials, uncertainties regarding Trevi's ability to execute on its strategy, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Katie Barrett Trevi Therapeutics, Inc. 203-304-2499 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected] SOURCE Trevi Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BOSTON--( BUSINESS WIRE )-- Kinaset Therapeutics , a clinical-stage biopharmaceutical company developing inhaled therapeutics to treat serious respiratory diseases, today announced two oral presentations and a late breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress being held September 7-11, 2024, in Vienna, Austria. The presentations demonstrate the potential of Kinaset’s lead clinical candidate, frevecitinib (KN-002), to treat all patients with moderate to severe asthma and patients with COPD. Kinaset’s leadership team, including Robert Clarke, PhD, co-founder and CEO, Frazer Morgan, co-founder and Chief Development Officer, and Christopher O’Brien, MD, PhD, Chief Medical Officer, will be attending the conference to engage with industry leaders and partners about its innovations in respiratory disease. Dave Singh, M.D., Professor, University of Manchester, Principal Investigator, and a scientific advisor to Kinaset, will be giving the oral presentations. Presentation Details: Oral Presentations Title: KN-002 reduces fractional exhaled nitric oxide in moderate to severe asthma Session Title: Airway diseases therapeutics: novel research studies Session Date and Time: Monday, September 9, 9:30 to 10:45 Presenter: Dave Singh, M.D., Professor, University of Manchester Location: Lehar 3 Title: Safety and PK of KN-002 in subjects with moderate to severe asthma using ICS/LABA Session Title: Recent advances in biological treatments for asthma and chronic obstructive pulmonary disease Session Date and Time: Monday, September 9, 14:15 to 15:30 Presenter: Dave Singh, M.D., Professor, University of Manchester Location: A1 Late Breaking Poster Presentation T itle: The safety and PK of an inhaled pan JAK inhibitor (KN-002) in subjects with COPD Session Title: Biological treatments for asthma: novel real-world and clinical studies Session Date and Time: Tuesday, September 10, 8:00-9:30 Location: PS-11, Board 18 About frevecitinib The United States Adopted Name (USAN) Council in consultation with the World Health Organization (WHO)’s International Non-proprietary Names (INN) Expert Committee, has approved the drug name frevecitinib for Kinaset’s lead drug candidate, KN-002. Frevecitinib is a novel, potent and balanced inhibitor of all JAK isoforms (i.e., JAK1, JAK2, JAK3 and TYK2) under development as a non-invasive anti-inflammatory treatment for all patients with eosinophilic and non-eosinophilic asthma inadequately controlled with medium- to high-dose ICS/LABA maintenance treatment plus those with COPD. Frevecitinib, formulated as a dry powder, has demonstrated excellent delivery efficiency enabling the administration of pharmacologically active doses via a single capsule resulting in therapeutic drug concentrations in lung tissue whilst minimizing systemic exposure levels. A Phase 1 clinical study (NCT05006521), involving 49 healthy volunteers, 55 subjects with mild or moderate to severe asthma and 13 subjects with COPD, has been successfully completed. A Phase 2b clinical study evaluating frevecitinib in patients with asthma not adequately controlled on medium to high dose ICS/LABA is planned to begin in 2025. About Kinaset Therapeutics, Inc. Kinaset Therapeutics is focused on developing inhaled therapeutics to address significant unmet medical needs in respiratory diseases. With founding investors 5AM Ventures, Atlas Venture and Gimv, the Company is pursuing a patient-focused approach to build a leading respiratory therapeutics company. See more information at the Company’s website .

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Harbour BioMed ("HBM", or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, today announced its interim results for the six months ended June 30, 2024. Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented, "In the first half of 2024, Harbour BioMed remained profitable, demonstrating the Company's remarkable resilience and adaptability in challenging market conditions. Our global operations continue to open new avenues for future growth. Our outstanding performance has validated the feasibility of the Two-Engine strategy, driven by Harbour Therapeutics and Nona Biosciences. We are confident in our ability to enhance value creation and drive sustainable growth by fully unlocking the tremendous potential of our core innovation engine." The Company reported revenues of US$23.7 million for the first half of 2024, achieving an overall profit of approximately US$1.4 million, with a solid cash balance exceeding US$183 million. Harbour Therapeutics: Robust Portfolio and Differentiated Pipeline The Company has a robust and diversified pipeline with potentially differentiated drug candidates in immuno-oncology and inflammatory and immunology diseases. Key products include HBM9161, HBM4003, HBM9378 and HBM1020. The Company aims to deliver at least one IND submission generated from the discovery engine each year. Batoclimab (HBM9161) is a novel, fully human anti-FcRn (neonatal fragment crystallizable receptor) monoclonal antibody which has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. In June 2023, the National Medical Products Administration (NMPA) of China accepted the BLA of batoclimab for the treatment of gMG, while in December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the BLA for batoclimab to the NMPA in June 2024, which was shortly accepted in July 2024. According to the analysis of the Open-Label extension clinical trial up to November 2023, the data demonstrated consistent efficacy and safety of batoclimab in long-term disease management. Its clinical results were published in JAMA Neurology in March 2024. Batoclimab received the "Breakthrough Therapy Certificate" from the NMPA in 2021 and achieved a positive outcome in the proof-of-concept study for treating Chinese gMG patients in July 2021. The positive topline results of its Phase III clinical trial were announced in March 2023. In October 2022, the Company entered into an agreement with NBP Pharma, a wholly owned subsidiary of the CSPC Group, to co-develop batoclimab in Greater China. The Company believes that the collaboration with CSPC Group enables the Company to optimize the market potential and advance the clinical development of batoclimab, so as to further maximize the value of batoclimab in Greater China. Porustobart (HBM4003) is a next-generation, fully human anti-CTLA-4 antibody targeting cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). It is the first internally developed molecule generated from HCAb Harbour Mice® platform. Porustobart is the first fully human heavy chain only anti CTLA-4 antibody entered into clinical development worldwide, and has favourable properties compared with conventional anti-CTLA-4 antibodies in pre-clinical settings. Notably, porustobart exhibits unique, favourable properties including significant Treg cell depletion and optimized pharmacokinetics for improved safety. While increasing the potential to selectively deplete intratumoral Treg cells via enhanced antibody-dependent cellular cytotoxicity (ADCC) strategy, the Company believes porustobart will be able to break the significant immune-suppressive barrier of anti-cancer immunotherapies in solid tumors. Porustobart has great potential to overcome the efficacy and toxicity bottleneck of the current CTLA-4 therapies, positioning it as a key product in cancer immunotherapy. The Company has implemented a global development plan for porustobart across multiple solid tumor types, with adaptive treatment designs. Positive data on efficacy and safety have been read out from the monotherapy trial targeting advanced solid tumors, as well as the trials of combination treatment with PD-1 inhibitor for melanoma, NEN, and HCC. In January 2024, patient enrolment for combination therapy with a PD-1 inhibitor for advanced colorectal carcinoma was initiated. HBM9378 is a fully human monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), developed from H2L2 Harbour Mice® platform. It inhibits the TSLP-mediated signalling pathway by blocking the interaction between TSLP and its receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization, and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. HBM9378 features fully human sequences, which reduce the risk of immunogenicity and improve bioavailability compared to other TSLP-targeting competitors. Its optimized long half-life and outstanding biophysical properties provide dosing and formulation benefits. HBM9378 has entered the clinical development stage in collaboration with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech). In February 2022, HBM9378 received IND approval from the NMPA for the treatment of severe asthma and initiated the Phase I trial in China. In October 2023, HBM9378 completed the Phase I clinical trial, and the initiation of its Phase II clinical trial is now ongoing. The Company is also preparing the IND application for a second indication, chronic obstructive pulmonary disease (COPD), for HBM9378. HBM1020 is a first-in-class, fully human monoclonal antibody generated from Harbour Mice® platform, targeting B7H7/HHLA2. As a newly discovered member of the B7 family, B7H7/HHLA2 expression is found non-overlapping with PD-L1 expression in multiple tumor types, suggesting it may play a key role for tumor cells to escape immune surveillance beyond PD-L1 mechanisms. HBM1020 is the first product targeting B7H7/HHLA2 in clinical stage globally. With its excellent product design and target features, the Company believes that HBM1020 has significant potential to address unmet medical needs in the treatment of solid tumors, particularly in patients with low PD-L1 expression and those resistant to PD-(L)1 therapies. The Company initiated a Phase I clinical trial in the U.S. in May 2023 and has since completed multiple dose levels. The latest progress of HBM1020 will be presented at the ESMO Congress 2024. Engaged in the discovery and development of differentiated antibody therapeutics in the areas of immuno-oncology and immunology, the Company are also exploring and developing multiple programs, including novel and challenging antibody therapeutics across various disease areas. In oncology field, alongside monoclonal antibodies (mAbs) such as HBM1022 (CCR8) and HBM9014 (a LIFR-targeting mAb), the Company is also generating bispecific antibodies from the HBICE® platform, featuring innovative designs and differentiated mechanisms such as HBM7020 (BCMAxCD3), HBM9027 (PD-L1xCD40), and HBM7004 (B7H4xCD3). In addition, leveraging the advantages of the Harbour Mice® platform and utilizing the XDC platform, the Company is exploring more therapeutic modalities in oncology, including HBM9033 (a MSLN-targeted ADC) and other ADC/RDC programs in early stages. In the inflammatory and immunology field, the Company has built a robust preclinical pipeline, encompassing bispecific and multi-specific antibody programs in targeting Type 2 pathways and for other inflammatory and immunology conditions. Nona Biosciences: An Efficient Value Creation Engine As a pioneer in innovative antibody platform technology, the Company continues to empower the innovators in the industry and support its collaborators from I to ITM (Idea to IND) through Nona Biosciences. By leveraging flexible business models and robust internal discovery capabilities, Nona Biosciences is maximizing platform value by combining the strengths of the Company with those of its collaborators. To fully utilize the unique platform technologies, Nona Biosciences continues to explore the expansion of platform technology applications, generating impactful values for the Company. The Company has established partnerships with over 25 industry pioneers and academic researchers, further expanding its collaboration network both in China and globally. In February 2024, Nona Biosciences entered into a collaboration agreement with Boostimmune, a biotech company dedicated to developing next-generation anti-cancer therapies via modulating immune systems. The collaboration aims to leverage Nona Biosciences' proprietary H2L2 Harbour Mice® to accelerate the development of ADCs against novel targets. In May 2024, Nona Biosciences entered into a license agreement with Astra Zeneca for preclinical monoclonal antibodies that will be used to create targeted therapies in oncology. Under the terms of the agreement, Nona Biosciences shall receive US$19 million upon completion of the transaction, is eligible to receive an additional US$10 million in potential near-term milestone payments and up to US$575 million upon achieving specified development, regulatory, and commercial milestones, as well as tiered royalty payments on net sales. In addition, Nona Biosciences is eligible to receive payments for the option programs should Astra Zeneca exercise these options. In July 2024, Nona Biosciences entered into a collaboration agreement with Alaya.bio, a biotechnology company developing a novel polymeric delivery platform, to precisely target and reprogram cells in situ and thus to significantly simplify the way CAR-T cell therapies are being developed, manufactured and administered. Nona Biosciences continuous to optimize, upgrade and further develop its technology, establishing a robust antibody discovery platform, protein engineering platform, conjugation technology platform, HCAb-CAR screening platform and delivery technology platform to use mRNA-encoding target gene as immunogen to tackle difficult targets. These platforms enable the Company to address more novel and challenging drug targets globally. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners, and select acquisitions. The proprietary antibody technology platforms Harbour Mice® generates fully human monoclonal antibodies in two heavy and two light chains (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology is capable of delivering tumor-killing effects unachievable by traditional combination therapies. Integrating Harbour Mice®, and HBICE® with a single B cell cloning platform, our antibody discovery engine is highly unique and efficient for the development of next-generation therapeutic antibodies. For further information, please visit SOURCE Harbour BioMed