Cerebral Hemorrhage

Atzumi™ (dihydroergotamine(DHE)) nasal powder is the first and only DHE nasal powder for the acute treatment of migraine with or without aura in adults in an easy-to-use, easy-to-carry device. Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify delivery of DHE. In clinical studies, Atzumi administration provided rapid and sustained DHE concentrations with low variability. DURHAM, N.C., April 30, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™(dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101. Migraine is a neurological disorder that is thought to be the result of temporary changes in the chemicals, nerves and blood vessels in the brain, with symptoms that are often incapacitating. According to the American Migraine Foundation, approximately 40 million Americans live with migraine. It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women. "The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology," said Dr. Ryoichi Nagata, President and CEO of Satsuma. "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems." "DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages", said Dr. Stewart J. Tepper, M.D., Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut. About Atzumi Atzumi is a proprietary drug device product incorporating both Satsuma's advanced nasal powder formulation of dihydroergotamine (DHE) administered via its unique nasal delivery device. The product is designed to provide patients an easy-to-use and easy-to-carry treatment option. The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine. About Dihydroergotamine (DHE) Since its approval in 1946, DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. IMPORTANT SAFETY INFORMATION WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of Atzumi with strong CYP3A4 inhibitors is contraindicated. Indication Atzumi is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. Contraindications Atzumi is not recommended in patients with: Concomitant use of strong CYP3A4 inhibitors Ischemic heart disease or coronary artery vasospasm Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment Hypersensitivity to ergot alkaloids Concomitant use of other 5-HT₁ agonists or ergotamine-containing or ergot-type medication within 24 hours Concomitant use of peripheral and central vasoconstrictors Warnings and Precautions Atzumi may cause: Cardiac events: Cardiac events in patients with risk factors of coronary artery diseases: Consider administration of the first dose of Atzumi under medical supervision (including the use of an electrocardiogram) Cerebrovascular events: Cerebrovascular events (eg, cerebral hemorrhage, subarachnoid hemorrhage, and stroke) have been reported, particularly with dihydroergotamine mesylate injection Vasospasm/elevated blood pressure: Dihydroergotamine may cause vasospasm or elevation in blood pressure Medication overuse headache: Detoxification may be necessary Preterm labor: Advise pregnant women of the risk Fibrotic complications: Rare cases have been reported following prolonged daily use of dihydroergotamine mesylate. Administration of Atzumi should not exceed the dosing guidelines or be used for chronic daily administration Local irritation: Local irritation has been reported following administration of Atzumi Most Common Adverse Reactions Most common adverse reactions (incidence >1%) were rhinitis, nausea, altered sense of taste, application site reaction, dizziness, vomiting, somnolence, pharyngitis, and diarrhea. Use in Special Populations Pregnancy: Available data from published literature indicate an increased risk of preterm delivery with Atzumi us during pregnancy. Lactation: Patients should not breastfeed during treatment with Atzumi and for 3 days after the last dose. Please see the Atzumi Full Prescribing Information, including Boxed Warning and Medication Guide. The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at . You can also call 1-888-273-2480 for additional information. About Satsuma Pharmaceuticals Satsuma Pharmaceuticals Inc., a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company headquartered in Research Triangle Park, North Carolina. Since its inception in 2016, Satsuma has focused on combining great science, cutting-edge technology and proven drug therapies to create improved therapeutic products that address the significant unmet needs of patients. Satsuma's team has extensive experience successfully developing, manufacturing and commercializing pharmaceutical products within both large and small companies, and we have particular expertise in the area of drug-device combination products delivered via inhalation. For further information, please visit . About SNBL Shin Nippon Biomedical Laboratories, Ltd. ("SNBL") (TSE:2395) is a listed nonclinical contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. Based on its corporate philosophy of "Committed to the environment, life, and people", and with a proven track record of accomplishment as the oldest and most established Japanese nonclinical CRO, SNBL is proud to offer a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research business engages in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. For further information, please visit . Cautionary Note on Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Satsuma's future business, future position and results of operations, including estimates, forecasts, targets and plans for Satsuma. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL's business, including uncertainty of commercial success for new and existing products; claims or concerns regarding the safety or efficacy of product candidates; general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; the impact of health crises such as the coronavirus pandemic on Satsuma and its clients and suppliers, including foreign governments in countries in which Satsuma operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Satsuma's operations and the timing of any such divestment(s); and other factors identified in SNBL's most recent securities report ("Yuka Shoken Houkokusho") and SNBL's other reports filed with the Financial Services Agency, available on SNBL's website at: or at . SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL's future results. Medical Information This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Inquiries: Satsuma Pharmaceuticals, Inc. E-mail: [email protected] Website: SOURCE Satsuma Pharmaceuticals, Inc. 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BIOX-101 is derived from a protein found in the salivary glands of a tick. \n Bioxodes has stopped enrolling people in a phase 2a stroke study after hitting the safety and efficacy endpoints, positioning the Belgian biotech to power into a potentially registrational trial.The interim phase 2a analysis included data on 16 intracerebral hemorrhagic stroke (ICH) patients. Some patients received a single intravenous dose of BIOX-101, also known as Ir-CPI, on top of standard of care. Other people only received standard of care. Bioxodes’ primary endpoints looked at safety outcomes. The biotech’s secondary endpoints assessed efficacy in the 10 days after randomization.At the interim analysis, the biotech saw positive changes in hematoma and edema volume, a secondary efficacy endpoint, and said inflammation biomarkers were encouraging. No patients died, and no serious adverse events were attributed to the drug. The treatment was well tolerated with no signs of increased bleeding.Hans Warrinnier, chief medical officer at Bioxodes, said in a statement that the results are preliminary but all point in the right direction. The biotech believes generating more phase 2a data won’t change the interim conclusions, leading it to stop enrollment in the study early. Bioxodes will now start raising a series B financing round and making BIOX-101 ready for a phase 2b trial. The process will take around one year, Bioxodes CEO Marc Dechamps said, putting the company on track to start enrolling patients in the potentially pivotal study in the first half of 2027. Bioxodes said the phase 2b could support filings for conditional marketing authorization in the U.S. and Europe before 2030.BIOX-101 is derived from a protein found in the salivary glands of a tick. The tick secretes the protein to stop the host’s blood from clotting and allow it to feed. Repurposed for treating ICH, the approach could tackle blood clots without causing bleeding. There are currently no approved treatments for ICH. Efforts to change that include a phase 3 study of recombinant factor VIIa (rFVIIa) that has an estimated complete date of January 2028. An earlier phase 3 trial found rFVIIa failed to improve survival or functional outcomes. That trial allowed patients to receive rFVIIa up to four hours after stroke onset. The ongoing rFVIIa trial has a treatment window of two hours. 

GOSSELIES, Belgium I April 24, 2025 I Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, today announces promising interim results from the BIRCH Phase 2a clinical trial of its lead asset, BIOX-101, to treat intracerebral hemorrhagic stroke (ICH). Interim analysis from the first 16 patients in the standard-of-care controlled, randomized trial showed that primary safety and secondary efficacy endpoints were met. The Data Monitoring Committee (DMC) identified no safety concerns related to changes in ICH volumes, serious adverse events, neurological outcomes, or mortality. Bioxodes will release a second interim report in the second half of 2025, and a final analysis of the study in 2026. The company has stopped recruitment for the trial, as it believes that adding more data would not alter the conclusions based on the available findings. Bioxodes will now start preparing the launch of a potentially registrational Phase 2b trial of BIOX-101 in ICH. “While preliminary, the data from this study all point in the right direction. This excellent result has given us the confidence to start the Phase 2b trial as soon as possible,” said Hans Warrinnier, Chief Medical Officer at Bioxodes. “Although hemorrhagic stroke often has debilitating consequences, it is a neglected disease, and the prospect of offering these patients hope is a strong motivating factor for our team.” “These encouraging results are an important milestone, which enables us to start looking ahead. We will now launch a Series B funding round, and start the CMC process required to produce sufficient BIOX-101 for the Phase 2b trial. This will take approximately a year to complete, so that we hope to start recruitment in the first half of 2027,” said Marc Dechamps, Chief Executive Officer at Bioxodes. No deaths have so far been recorded in the patient population, a surprisingly positive outcome, and no serious adverse events were attributed to treatment over the course of the trial. Treatment was well-tolerated, with no signs of increased bleeding. Data showed a consistent exposure to the drug during infusion, while pharmacodynamic data aligned well with pharmacokinetic findings. Imaging data suggested a favorable evolution of hematoma and edema volumes, while exploratory outcomes on inflammation biomarkers measurements were very encouraging. ICH is a devastating condition, which while accounting for only 13% of all cases of stroke, is behind 40% of all stroke-related deaths. There is currently no approved treatment, and many survivors are left with permanent or long-term disability. Bioxodes received Orphan Drug Designation for BIOX-101 in both the U.S. and in Europe in March 2025. The company is planning to file for PRIME status with the EMA later in 2025, and for Fast Track designation with the FDA later during development of the product. The planned Phase 2b trial could be sufficient to submit BIOX-101 for conditional marketing authorizations in the U.S. and Europe before 2030. BIOX-101 is a recombinant version of a small protein found in the saliva of the tick ( Ixodes ricinus ). It is designed to inhibit the harmful secondary effects of hemorrhagic stroke such as secondary ischemia, neuroinflammation and neuronal damage. The product exerts its anti-inflammatory effects by inhibiting activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier. Unlike currently marketed anticoagulants, BIOX-101 reduces clotting without increasing bleeding, by targeting Factors XIa and XIIa of the intrinsic coagulation pathway. Bioxodes is currently investigating the possibilities of a Phase 2 trial with BIOX-101 in acute ischemic stroke. Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat thromboinflammatory disease. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for the prevention of (thrombo)inflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region, and the company is registered in Belgium under number 825.151.779 . SOURCE: Bioxodes