Oregon Health & Science University

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced it will host a virtual key opinion leader (KOL) event on Wednesday, November 20, 2024 at 2:00 PM ET. To register, click here. The event will feature Abhishek Ray, MD (University Hospitals) and Andrew Webb, PharmD, BCCCP (Massachusetts General Hospital), who will discuss the high unmet medical need and current treatment landscape for patients suffering from aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency. A live question and answer session will follow the formal presentations. About Abhishek Ray, MD Abhishek Ray, MD, is a fellowship-trained, board-certified neurological surgeon at University Hospitals and Associate Professor of neurological surgery at Case Western Reserve University School of Medicine. He specializes in caring for people with cerebrovascular disease (brain aneurysms, stroke, AVMs), pituitary tumors and meningiomas, and in minimally invasive techniques to treat degenerative spine disease. In neurological surgery, there are often multiple ways to treat a single problem, and Dr. Ray is committed to providing each patient with an individualized care plan to optimize results. In 2021, 2022, 2023, and 2024, he was selected by his peers to be included in Cleveland Magazine’s list of Top Doctors. After completing his undergraduate degree in biological systems engineering at the University of California – Davis, Dr. Ray went back to his hometown to attend medical school at the University of Kansas School of Medicine in Kansas City, Kansas, where he was elected to be an ambassador of the school and was inducted into the Alpha Omega Alpha Honor Medical Society. He then went on to complete neurological surgery residency at University Hospitals/Case Western Reserve University School of Medicine, where he also completed fellowship training in neuro-interventional surgery. Dr. Ray stayed on as faculty at UH/Case Western Reserve University School of Medicine to advance neurosurgical education there. He created a unique and comprehensive neurological surgery elective for second-year medical students, of which he is now the course director. He has been an instructor at national skull base courses for neurosurgical residents and fellows and has served as editor of the neuro-interventional section of CNS Nexus, an online library of neurosurgical cases to better prepare trainees for the operating room. About Andrew Webb, PharmD, BCCCP Andrew Webb, PharmD, BCCCP, is a board-certified neurocritical care clinical pharmacy specialist at Massachusetts General Hospital (MGH) and serves as adjunct clinical faculty at Northeastern University School of Pharmacy and Pharmaceutical Sciences. His clinical and research interests include subarachnoid hemorrhage, status epilepticus, traumatic brain injury, and optimizing the medical management of neurocritically ill patients and his clinical practice is on the multidisciplinary neurocritical care team at MGH’s 22-bed neurosciences intensive care unit. Dr. Webb is originally from Rhode Island and completed his undergraduate studies and Doctor of Pharmacy at the University of Rhode Island. He then completed his pharmacy practice residency at Mayo Clinic in Rochester, MN followed by residency in critical care at Oregon Health & Science University in Portland, OR. Dr. Webb serves on the MGH Comprehensive Stroke Center Quality Taskforce and the MGH Neurology Quality Assurance and Committee on Patient Safety, focusing on improving the quality, safety, and effectiveness of medication therapy in stroke, subarachnoid hemorrhage, and other neurologic conditions. He is active in the Neurocritical Care Society, American College of Clinical Pharmacy, and Society for Critical Care Medicine and serves on several committees within these organizations related to critical care and neurology practice, research, and education. He has lectured regionally and nationally on the pharmacotherapy of subarachnoid hemorrhage, status epilepticus, and the unique challenges of pharmacotherapy in neurocritical care. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTx-102 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-102 drug candidate. GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-101 drug candidate. About Grace Therapeutics Grace Therapeutics is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutics’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’s lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.gracetx.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the timing of a data readout from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Grace Therapeutics'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, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Grace Therapeutics's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Grace Therapeutics Contact: Prashant KohliChief Executive OfficerTel: 609-322-1602Email: info@gracetx.com www.gracetx.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

HMI-115 has demonstrated statistically significant improvement in endometriosis painThe mean dysmenorrhea pain score was reduced by 42%The mean non-menstrual pelvic pain score was reduced by 50%Most of the patients reported normal menstrual periodsNo typical peri-menopausal symptoms were reportedThere were no significant changes in bone mineral density or key sex hormone levels About 190 million women worldwide suffer from endometriosis, making up a market size of $200 billion SHANGHAI, Oct. 23, 2024 /PRNewswire/ -- Hope Medicine Inc. ('HopeMed'), a clinical-stage innovative biopharmaceutical company, announced positive results from an interim analysis of a global Phase 2 study, " A Randomized, Multicenter, Double-Blind, Placebo -Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women with Moderate to Severe Endometriosis Associated Pain Over a 12-Week Treatment Period". HMI-115 is a monoclonal antibody that blocks the prolactin receptor. It is a first-in-class treatment for endometriosis. Notably, HMI-115 has been granted Breakthrough Therapy Designation by the National Medical Products Administration ("NMPA") in China. Continue Reading Hope Medicine This Phase 2 study included 142 female patients with endometriosis in US, Poland and China. HMI-115 has demonstrated statistically significant improvement in endometriosis associated pain. HMI-115 was well-tolerated with no treatment-related serious adverse events. Specifically, in the first 102 patients included in the interim analysis, at the end of the study treatment, the mean dysmenorrhea pain score was reduced by 42% in the 240 mg q2w group, compared to the baseline. The mean non-menstrual pelvic pain score was reduced by 50%. These reductions were statistically significant compared to placebo. Most of the patients reported normal menstrual periods. No typical peri-menopausal symptoms were reported. There were no significant changes in bone mineral density and sex hormone levels including estradiol, LH, FSH and progesterone. "Endometriosis is a common and debilitating disease among women," said Dr. Hugh Taylor, Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology, at Yale School of Medicine, "for decades, patients and physicians have been seeking an endometriosis treatment that provides pain relief and does not alter sex-steroid hormones. HMI-115 has the potential to fulfill this unmet medical need." "The findings from this proof-of-concept study are exciting," said Dr. Jeffrey Jensen, Leon Speroff Professor of Obstetrics and Gynecology, at the School of Medicine, Oregon Health & Science University, "in contrast to existing treatments like GnRH blockers, HMI-115 does not disrupt the normal menstrual cycle and maintains physiologic levels of sex hormones to prevent menopausal symptoms and bone loss. Unlike hormonal therapies, the approach is not contraceptive and could offer particular benefit to women with endometriosis seeking pregnancy. I was very impressed to see a significant impact on both menstrual and non-menstrual pain." "HMI-115 is first-in-class," said Professor Rui-Ping Xiao, founder of Hope Medicine, "this study is the first ever to show that prolactin receptor blockade can treat patients suffering from endometriosis. For the last 40 years people have been calling for a new target that provides pain relief while bypassing sex hormones, we are answering that call." "We are very encouraged by the success of this proof-of-concept trial," said Nathan Chen, CEO of Hope Medicine," in the coming months, we plan to hold End-of-Phase 2 meetings with FDA, NMPA, and other key regulatory authorities to determine next steps for the development of HMI-115. We plan to move quickly towards global Phase 3 trials, so that patients can begin to benefit from HMI-115 as soon as possible. We are dedicated to improving women's health worldwide." About Endometriosis About 190 million women worldwide suffer from endometriosis, making up a global market size of approximately $200 billion dollars. Endometriosis affects about 10% women of childbearing age. Endometriosis is a common gynecological disease characterized by the implantation of endometrial cells in locations outside the endometrium, typically presenting as chronic inflammations. The endometrium is a mucosal layer within the uterine cavity that undergoes hormone dependent changes during the menstrual cycle. Endometriosis symptoms include lower abdominal and pelvic pain, dysmenorrhea, painful intercourse, and infertility. About half of the infertilities in women are associated with endometriosis. Endometriosis negatively impacts patients' quality of life and sex, psychology, and social behavior. About Hope Medicine Hope Medicine Inc. is a science-driven clinical-stage biopharmaceutical company with research laboratories and offices in Beijing, Shanghai, and Nanjing, China. HopeMed is established on the in-depth expertise in translational medicine and decades of research of Professor Rui-Ping Xiao's laboratory at the Institute of Molecular Medicine of Peking University. Based on excellent scientific research and to improve the quality of life, HopeMed is committed to the research, development, and commercialization of first-in-class medicines for common and major diseases that threaten human health. CONTACT: [email protected] SOURCE Hope Medicine Inc. 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- VTAMA® (tapinarof) cream, 1% demonstrated early, significant, and meaningful achievement of both no-to-minimal itch (mean weekly PP-NRS≤1) and sleep improvement in ADORING 1 and ADORING 2. - 31.4% and 33.0% of patients treated with VTAMA cream in ADORING 1 and ADORING 2, respectively achieved no-to-minimal itch at Week 8 (P=0.0072 and P=0.0003 versus vehicle). Results were statistically significant at Week 1, with continued improvement through Week 8. - Similarly, sleep improvements with VTAMA cream were statistically significant for patients ≥12 years old and <12 years old versus vehicle at Week 8 (both P<0.0001), with statistical significance achieved at Week 1, the earliest assessment. LONG BEACH, Calif., and BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data on the achievement of no-to-minimal itch (weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS≤1); also referred to as an itch-free state) and sleep improvement in patients with atopic dermatitis as young as two years old at the American College of Allergy, Asthma and Immunology Annual Meeting, being held in Boston, MA, October 24-28, 2024. The data presented were generated from Dermavant’s Phase 3 ADORING 1 and ADORING 2 pivotal trials studying VTAMA cream, 1% in patients with moderate to severe atopic dermatitis as young as two years old. In the ADORING pivotal trials, adults and children (n=813) were randomized to VTAMA cream or vehicle once daily for eight weeks. In ADORING 1 and ADORING 2, vIGA-AD TM success, defined as vIGA-AD=0 or 1 and ≥2-grade improvement from baseline at Week 8, was achieved by 45% and 46% of patients on VTAMA cream vs 14% (P<0.0001) and 18% (P<0.0001) of patients on vehicle, respectively. The most common adverse reactions (incidence ≥1%) in patients treated with VTAMA cream were folliculitis, nasopharyngitis, headache, asthma, and influenza. Peak Pruritus Numerical Rating Scale (PP-NRS) data, a patient reported outcome, were used to assess pruritus (itch) relief. Sleep improvement was assessed using question two, (Over the last week, on how many nights has your/your child’s sleep been disturbed because of eczema?) on the Patient Oriented Eczema Measure (POEM), using a 5-point scale. Results: A statistically significant improvement in sleep, achievement of no-to-minimal itch (PP-NRS≤1), and mean weekly PP-NRS<2 targets were observed as early as Week 1 (first assessment) with continued improvement observed through Week 8 in patients with atopic dermatitis treated with VTAMA cream versus vehicle. The proportion of patients with atopic dermatitis achieving no-to-minimal itch was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 31.4% vs 17.4% (P=0.0072) and 33.0% vs 14.0% (P=0.0003). The proportion of patients with atopic dermatitis achieving PP-NRS<2 was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 48.1% vs 28.4% (P=0.0006) and 46.8% vs 19.6% (P<0.0001). Sleep improvement reached statistical significance with VTAMA cream versus vehicle at Week 1, the earliest assessment, and continued through Week 8 in a pooled analyses for ADORING 1 and ADORING 2 in both patients with atopic dermatitis aged 2-11 years and ≥12 years: -1.7 vs -1.0 (P<0.0001) and -1.4 vs -0.8 (P<0.0001). “In the ADORING 1 and ADORING 2 trials, VTAMA cream demonstrated an early, significant, and meaningful achievement of no-to-minimal itch and improvement in sleep, for patients with atopic dermatitis” said Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of the CLEAR Eczema Center, at the Oregon Health & Science University. “Itch frequently causes sleep disturbance in patients with atopic dermatitis, which can be especially burdensome for young patients and their families. In the ADORING pivotal trials, VTAMA cream demonstrated significant itch reduction and sleep improvement, in patients with atopic dermatitis, versus vehicle and was well-tolerated in both adults and children down to two years of age. Subject to FDA approval, VTAMA cream could become a compelling new treatment option for atopic dermatitis patients, most of whom regard itch as one of the most bothersome symptoms of their disease.” About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study. About Atopic Dermatitis Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. For more information, please visit and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ). © 2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co. Contacts dna Communications: Jillian Parker Account Director, Media Relations, Healthcare jparker@dna-comms.com 732-501-2624