Acute repetitive seizure

The agreement gives Angelini Pharma an option to exclusive licensing rights to develop and commercialize CV-011, a clinical Phase 1 investigational novel compound with broad potential to treat brain health diseasesCureverse receives undisclosed upfront payments and is eligible for future milestone-dependent payments and royalties, while retaining rights to commercialize CV-01 in the Republic of Korea, China, Hong Kong, Macau and TaiwanThe collaboration builds on Angelini Pharma’s strong portfolio and deep therapeutic expertise in brain health as well as Cureverse’s early development know-how and capabilities ROME, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Angelini Pharma, part of the privately owned Angelini Industries, and Cureverse Inc., an early-stage research and development company, announced today that they entered into an exclusive global option agreement for the development and commercialization of Cureverse’s innovative brain health asset CV-01. Under the terms of the agreement, Angelini Pharma will lead all the development efforts for CV-01 and, following an initial option period, will have the right to obtain the global exclusive development and commercialization license for the compound, outside of the Republic of Korea, China, Hong Kong, Macau and Taiwan. CV-01 is a novel and innovative investigational compound that activates protective pathways regulated by the nuclear factor erythroid 2-related factor 2 (Nrf2) and has a strong potential to be a medication with disease-modifying properties across a range of brain health disorders, including epilepsy.i CV-01 is an investigational compound currently undergoing a Phase 1 clinical trial in the Republic of Korea and is being developed by Cureverse for Alzheimer’s Disease. Cureverse will receive an upfront payment and will also be eligible to receive additional payments upon pre-defined development and commercial milestones of up to approx. US$360 million, as well as tiered royalties on post-approval net sales. “Our strategic collaboration with Cureverse further strengthens Angelini Pharma’s position as an emerging leader in brain health,” said Jacopo Andreose, Chief Executive Officer of Angelini Pharma. “Neurological conditions such as epilepsy are among leading causes of disease burden worldwide.ii While significant progress has been achieved in the past 15 years, many people living with epilepsy are still unable to reach seizure control despite combination treatment of several anti-seizure medications.iii Through the development of CV-01 and potentially other compounds, we aim to provide much-needed solutions for people living with brain health conditions across the world.” “Our research has unveiled the remarkable potential of CV-01 to transform the landscape of brain health, from epilepsy to Alzheimer’s and Parkinson’s Disease,” said Sung Jin Cho, Chief Executive Officer at Cureverse Inc. “We are truly delighted to be partnering with Angelini Pharma on this journey. Their deep therapeutic expertise and commitment to brain health perfectly align with our vision. Together, we are not just developing a treatment—we are paving the way for a future where patients with neurological conditions have access to truly life-changing therapies.” About Brain HealthBrain health as a therapeutic area includes both neurological and mental health conditions.iv Brain health is defined by the World Health Organization as a state of brain functioning across cognitive, sensory, social-emotional, behavioral and motor domains, allowing a person to realize their full potential over the course of their life, irrespective of the presence or absence of disorders.v Brain health represents an urgent global health priority. An estimated 179 million Europeans are living with brain health conditionsvi and more than 18% of all health loss around the world is associated with brain conditions.vii Additionally, brain health conditions are responsible for considerable individual, economic and societal impact, including loss of independence, reduced productivity, strained relationships, increased risk of suicide as well as high healthcare costs.viii There is an urgent need to raise awareness, and reduce stigma, prejudice and discrimination, to ensure that brain health is valued, promoted and protected for all.v About EpilepsyEpilepsy is one of the most widespread neurological diseases in the world, affecting globally approximately 50 million people of all ages.ix In Europe, up to six million people are estimated to be living with this disease.x Epilepsy can have multiple potential causes, including structural, metabolic, genetic and other factors, though approximately half of cases worldwide do not have a known cause.ix The complications associated with epilepsy are severe, with a risk of premature mortality up to three times higher than the general population.ix The recurrent seizures associated with this condition also have wide-ranging effects on a person’s broader physical and mental health, education and employment opportunities and other quality of life factors. ix Treatments are available to help reduce seizures and improve quality of life, however approximately 40% of people living with epilepsy are still uncontrolled despite the treatment with two anti-seizure medications.iii About Angelini PharmaAngelini Pharma is an international pharmaceutical company, part of the privately owned multi-business Angelini Industries. The Company researches, develops and commercializes health solutions with a focus on the areas of Brain Health, including Mental Health and Epilepsy, and Consumer Health. Founded in Italy at the beginning of the 20th century, Angelini Pharma operates directly in 20 countries, employing more than 3,000 people. Its products are marketed in over 70 countries through strategic alliances with leading international pharmaceutical groups. For more information about Angelini Pharma please visit https://www.angelinipharma.com. About Angelini IndustriesAngelini Industries is a multinational industrial group founded in Ancona in 1919 by Francesco Angelini. Today, Angelini Industries represents a solid and diversified industrial reality that employs approximately 5,800 employees and operates in 21 countries around the world with revenues of over 2 billion euros, generated in the health, industrial technology, and consumer goods sectors. A targeted investment strategy for growth; constant commitment to research and development; deep knowledge of markets and business sectors, make Angelini Industries one of the Italian companies of excellence in the sectors in which it operates. To learn more visit www.angeliniindustries.com. About Cureverse Inc.Founded in 2021, Cureverse has rapidly become a key innovator in the Korean biotech landscape, with a bold vision to revolutionize brain health on a global scale. Specializing in cutting-edge small-molecule therapies, Cureverse focuses on tackling central nervous system (CNS) disorders like Alzheimer’s disease (AD), aiming to bring hope to millions worldwide. While many AD drugs have made it to market, a true breakthrough has yet to be realized—until now. At the heart of our innovation is CV-01, a 'First-in-Class' therapy that uniquely targets the Keap1/Nrf2 pathway, activating Nrf2 through precise modulation. This approach offers unprecedented selectivity, effectively controlling neuroinflammation with precision unmatched by existing treatments. Alongside CV-01, Cureverse is actively advancing CV-02, a biased S1P1 agonist that is now IND-ready, as well as several promising follow-up non-clinical programs. With recent IND approvals and strong clinical progress, Cureverse is well-positioned to transform the way we treat neurological conditions and improve patients' lives across the globe. Media Contact Chiara AntoniucciGlobal Head of Brand and Media Communications, Angelini PharmaPhone: +39 3477133926Email: chiara.antoniucci@angelinipharma.com Sung Jin ChoChief Executive Officer, Cureverse Inc.Email: sjcho@cureverse.co.kr, sjcho@kist.re.kr ________________________________ 1 CV-01 is an investigational compound, not approved for use by regulatory authorities i Data on file from Cureverse.ii Institute for Health Metrics and Evaluation. Global burden of conditions affecting the nervous system. Available at: https://www.healthdata.org/research-analysis/library/global-burden-conditions-affecting-nervous-system Last accessed: October 2024.iii Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279-286.iv Winkler AS, et al. Lancet Glob Health. 2024;12(5):e735-e736.v World Health Organization. Optimizing brain health across the life course: WHO position paper. Geneva: World Health Organization; 2022.vi Nutt D, et al. Eurohealth (Int) 2017;23:21–5.vii Institute for Health Metrics and Evaluation. Understanding brain health around the world. Available at: https://brainhealthatlas.org/ Last accessed: October 2024.viii World Health Organization. World mental health report: transforming mental health for all. Geneva: World Health Organization; 2022.ix WHO. “Epilepsy Key Facts.” N.p., 9 Feb. 2023. Web. 24 Aug. 2023.x Behr et al. Epidemiology of epilepsy. Revue Neurologique 2016 Jan; 172(1):27-36. doi: 10.1016/j.neurol.2015.11.003.

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that it has dosed the first subjects with SAN711 in a Phase 1 multiple ascending dose (MAD)/biomarker study. This marks a significant milestone that put the foundation for launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. Topline data from the Phase 1 study is anticipated by the end of 2024. This Phase 1 MAD/biomarker study will investigate three critical aspects to inform future clinical trials: the effect of food intake on SAN711 dosing, the safety and tolerability as well as the potential benefits of higher doses using clinically relevant pharmacodynamic biomarkers. These insights will refine the dosing strategy for future patient studies as the Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of SAN711 in higher doses than those used in the previous Phase 1 study, while gathering data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. Saniona’s earlier Phase 1 study demonstrated excellent tolerability and indicated potential therapeutic benefit at relevant clinical plasma concentrations. The current study builds on these findings by exploring whether higher doses can offer even greater potential without compromising safety. Additionally, preclinical data suggests that SAN711 selective pharmacology modulates certain brain circuits, which can be detected via EEG measurements during both awake and sleep states. This not only serves as a functional biomarker of SAN711’s activity in the brain but may also indicate potential benefits for patients in future studies. The study is being conducted in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy. Both Evotec and CRC bring extensive expertise in neurological and psychiatric clinical research, which will support the successful execution of the study. About SanionaSaniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of epilepsy and other neurological disorders. Saniona’s epilepsy pipeline features SAN711, a Phase 2-ready candidate drug targeting absence seizures, SAN2219 for acute repetitive seizures, and SAN2355, addressing refractory focal onset seizures. Beyond epilepsy, Saniona oversees four clinical programs poised for collaboration. Tesofensine, Saniona’s most advanced candidate, is progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. Tesomet™ is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease and SAN2465 is set for preclinical development for major depressive disorder. Saniona has esteemed partners, including Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V, AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market.For more information, please visit www.saniona.com.

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces significant progress in the preclinical development of SAN2355, a new generation Kv7.2/Kv7.3 activator aimed at treating focal onset seizures. The company has identified a stable solid form of the compound and completed synthesis optimization, enabling a robust, scalable manufacturing process. As a result, Saniona has successfully produced 4 kg of SAN2355 for GLP toxicology studies. “We are delighted to have completed the analytical development, synthesis optimization, and production of the GLP toxicology batch. We expect the remaining preclinical work to take about nine months, which means that SAN2355 could enter Phase 1 clinical trials by Q3 2025,” said Janus Schreiber Larsen, Chief Development Officer at Saniona. “SAN2355 is a key asset in our epilepsy portfolio. Kv7 activators have previously been clinically and commercially validated for treating refractory focal onset epilepsy, but no products are currently available on the market. SAN2355 stands out due to its unique selectivity profile and has the potential to become best in class, addressing significant unmet needs in the epilepsy market,” added Thomas Feldthus, CEO of Saniona. The GLP toxicology batch was produced with assistance from the Danish firm Niels Clauson-Kaas, and the project is now ready for preclinical toxicity and safety studies, in compliance with GLP standards. About Kv7 Channels and Epilepsy Epilepsy is a neurological disorder characterized by recurrent seizures, affecting millions globally. Around 30% of patients do not respond to existing treatments, highlighting a critical unmet need. Kv7 channels are crucial for regulating potassium ion transport across neuronal membranes, helping to prevent uncontrolled nerve impulses. Kv7.2 and Kv7.3 subunits, primarily expressed in the brain, play a key role in dampening overactive neurons, thus preventing seizures. While the non-selective Kv7 activator retigabine demonstrated proof-of-concept for treating resistant focal onset seizures, it was withdrawn from the market due to side effects unrelated to its target. About SanionaSaniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of epilepsy and other neurological disorders. Saniona’s epilepsy pipeline features SAN711, a Phase 2-ready candidate drug targeting absence seizures, SAN2219 for acute repetitive seizures, and SAN2355, addressing refractory focal onset seizures. Beyond epilepsy, Saniona oversees four clinical programs poised for collaboration. Tesofensine, Saniona’s most advanced candidate, is progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. Tesomet™ is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease and SAN2465 is set for preclinical development for major depressive disorder. Saniona has esteemed partners, including Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V, AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market.For more information, please visit www.saniona.com.