Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial

The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. This study also aims to screen potential study centers and gather data to refine the sample size calculation for a larger, future trial. The main questions it aims to answer are:
* Does extending the interval between injections maintain effectiveness in improving shoulder function and reducing pain for frozen shoulder?
* Which centers in this pilot study are qualified for a larger, future trial?
* What is the appropriate sample size for conducting a multicenter RCT study with the same research design at the selected centers?
Participants will:
* Receive 3 injections over 4 weeks and will be followed up for another 8 weeks
* Complete shoulder function assessments
* Perform home rehabilitation exercises

Start Date15 Oct 2024

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

100 Clinical Results associated with Betamethasone

100 Translational Medicine associated with Betamethasone

100 Patents (Medical) associated with Betamethasone

4,526

Literatures (Medical) associated with Betamethasone

01 Jan 2025·THERIOGENOLOGY

Dexamethasone and azithromycin enhance goat sperm preservation quality by regulating lipid metabolism

Article

Author: Ren, Chunhuan ; Zhang, Zijun ; Cao, Hongguo ; Xu, Yongjie ; Ling, Yinghui ; Sun, Shixin ; Wang, Mingyue ; Shen, Wenzheng ; Wang, Lei

Phospholipase A (PLA) in goat semen aggregates with egg yolk in semen diluent, leading to sperm death. The aim of this study is to address the issue of sperm death caused by the interaction between PLA and egg yolk, and to explore the protective effect and metabolic regulation mechanism of the combination of dexamethasone (DXMS) and azithromycin (AZM) on goat sperm under low temperature conditions. At a low temperature of 4 °C, different concentrations of DXMS were added to semen diluents containing 30 μg/mL AZM to detect the quality of goat sperm. The optimal concentration of DXMS was determined to be 20 μg/mL. On the 5th day of storage, antioxidant capacity, total cholesterol (TC) levels, energy metabolism, and metabolomics analysis were performed on the sperm of the 20 μg/mL DXMS group. The results showed that there was no aggregation caused by the interaction between PLA and egg yolk in the group containing 30 μg/mL AZM at 4 °C. 20 μg/mL DXMS significantly improved sperm motility, plasma membrane integrity, acrosome integrity, glutathione peroxidase (GPX) (P < 0.05), catalase (CAT) (P < 0.01), and superoxide dismutase (SOD) activity (P < 0.01). The content of reactive oxygen species (ROS) and Fe²⁺ significantly decreased (P < 0.01), while the content of ATP (P < 0.01) and TC (P < 0.05) significantly increased. Through metabolomics analysis, a total of 56 differential metabolites (P < 0.05) were screened, including 5a, 6-Anhydrotetracycline, Betamethasone, and 11-Dehydrocorticosterone, mainly enriched in 8 metabolic pathways (P < 0.05), including steroid hormone biosynthesis, glycerophospholipid metabolism, and choline metabolism in cancer. Among them, 5 metabolic pathways are related to lipid metabolism. The results indicate that AZM effectively inhibits the aggregation of PLA and yolk, and the combination of AZM and DXMS enhances the preservation quality of goat sperm during low-temperature preservation by regulating lipid metabolism.

01 Jan 2025·Current Drug Delivery

Nigella sativa Oil-loaded Ethanolic Vesicular Gel for Imiquimod-induced Plaque Psoriasis: Physicochemical Characterization, Rheological Studies, and In vivo Efficacy

Article

Author: Pundir, Swati ; Vihal, Samar ; Kumar Chellappan, Dinesh ; Gupta, Gaurav ; Dua, Kamal ; Negi, Poonam ; Kumar Singh, Sachin ; Ranjan Lal, Uma ; Rathore, Charul

Background::

The therapeutic effect of NS oil in mild to moderate psoriasis is limited owing to low play load of thymoquinone (<15 %w/w), irritation, dripping, low viscosity and thus, less contact time on the lesions.

Aims:::

This study aimed at developing and characterizing the ethanolic vesicular hydrogel system of Nigella sativa (NS) oil (NS EV hydrogel) for the enhancement of anti-psoriatic activity.

Objective::

The objective of this study was to develop NS EV hydrogel and evaluate its anti-psoriatic activity.

Methods::

The identification and quantification of TQ content in different NS seed extracts and marketed oil were measured by an HPTLC method using n-hexane and ethyl acetate as solvent systems. Preparation of ethanolic vesicles (EVs) was performed by solvent injection method, while its antipsoriatic activity was evaluated employing an Imiquad (IMQ)-induced plaque psoriasis animal model.

Results::

A compact HPTLC band was obtained for TQ at an Rf value of 0.651. The calibration plot was linear in the range of 1-10 μg/spot, and the correlation coefficient of 0.990 was indicative of good linear dependence of peak area on concentration. From the different NS sources, the high TQ content was obtained in the marketed cold press oil, i.e., 1.45±0.08mg/ml. Out of various NS oilloaded EVs, the F6 formulation revealed the smallest particle size (278.1nm), with log-normal size distribution (0.459) and adequate entrapment efficiency. A non-uniform shape was observed in the transmission electron microscopy. The viscosity of F6 formulation hydrogel was 32.34 (Pa·s), which exhibited plastic behavior. In vivo, efficacy studies demonstrated decreased inflammation of the epidermis and dermis and a marked decrease in the levels of IL-17 by NS EV hydrogel compared to plain NS oil and standard drugs (Betamethasone and Dr. JRK Psorolin Oil).

Conclusion::

It may be concluded from the findings that NS-loaded EV gel was as good as betamethasone cream but more efficacious than the other treatments.

01 Jan 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Clinically relevant cell culture model of inflammatory bowel diseases for identification of new therapeutic approaches

Article

Author: Moulari, Brice ; Pellequer, Yann ; Cornu, Raphaël ; Béduneau, Arnaud ; Antoine, Thomas ; Bonnefoy, Francis ; Perruche, Sylvain ; Chrétien, Claire

Inflammatory Bowel Diseases (IDB) are chronic disorders characterized by gut inflammation, mucosal damage, increased epithelial permeability and altered mucus layer. No accurate in vitro model exists to simulate these characteristics. In this context, drug development for IBD or intestinal inflammation requires in vivo evaluations to verify treatments efficacy. A new model with altered mucus layer composition; altered epithelial permeability and pro-inflammatory crosstalk between immune and epithelial cells will be developed to enhance in vitro models for studying IBD treatments. The effects of dextran sulfate sodium and/or lipopolysaccharides on intestinal permeability, cytokines synthesis (IL-6, IL-8, TNF-α and IL-1β), mucins (MUC2, MUC5AC) and tight junction proteins expression (Claudin-1, ZO-1 and Occludin) were investigated in a tri-coculture model combining differentiated Caco-2/HT29-MTX cells and THP-1 cells. Two anti-inflammatory agents were evaluated to assess the model's therapeutic strategy applicability (corticoids and pro-resolving factors). Two in vitro models have been developed. The first model, characterized by increased permeability of the epithelial layer and subsequent secretion of inflammatory cytokines, can reproduce the different phases of inflammation, and enables the evaluation of preventive treatments. The second model simulates the acute phase of inflammation and allows for the assessment of curative treatments. Both models demonstrated reversibility when treated with betamethasone and pro-resolving factors. These in vitro models are valuable for selecting therapeutic agents prior to their application in in vivo models. They enable the assessment of agents' anti-inflammatory effects and their ability to permeate the inflamed epithelial layer and interact with immune cells.

News (Medical) associated with Betamethasone

30 Oct 2024

·www.globenewswire.com

Grace Therapeutics to Host Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage on November 20, 2024

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

Phase 1Orphan Drug

25 Oct 2024

·www.globenewswire.com

Acasti Announces Corporate Name Change to Grace Therapeutics, Inc.

Name Change Reflects Extensive Scientific and Corporate Brand Equity Previously Established under Grace Therapeutics Grace Therapeutics will begin trading on Nasdaq under the trading symbol "GRCE" effective October 28, 2024 Virtual Key Opinion Leader Event to be held on November 20th PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti 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 that it is changing its name to Grace Therapeutics, Inc. (Grace Therapeutics). Grace Therapeutics was the name of the company developing GTx-104 prior to its merger with Acasti in 2021. Grace Therapeutics will begin trading on Nasdaq under the trading symbol “GRCE” at the open of the market on October 28, 2024 and all company branding including corporate website will be updated accordingly. “The Grace Therapeutics brand reconnects us to our roots that are steeped in scientific innovation and highlights our transformative journey,” said Prashant Kohli, CEO of Acasti. “The breakthrough formulation of GTx-104 is the result of a decade of research by our exceptional scientific team while Grace Therapeutics was located in the pharma industry research corridor of New Jersey. We have continued to make significant progress in the clinical development plan of GTx-104, including full enrollment of the STRIVE-ON trial and anticipate a data readout in early calendar 2025 with an expected submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of calendar 2025. “In addition to advancing GTx-104 over the past 18 months, we successfully restructured to an agile biopharma model, rebuilt the management team, prioritized the pipeline, divested legacy assets, strengthened the balance sheet, and re-domiciled to the United States as a Delaware corporation. We believe these steps offer several potential benefits, including a U.S. corporate structure that should increase the company’s attractiveness and marketability to potential strategic partners and global institutional investors. We are proud of the progress made within a relatively short timeframe and look forward to fully realizing the Company’s value under the Grace Therapeutics brand.” The Company will host a Key Opinion Leader (KOL) event titled Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage, on November 20, 2024 at 2pm Eastern Time. To register for this debut event hosted by Grace Therapeutics, click here. A replay of the event will be available and archived for at least 180 days after the webcast. About the Acasti 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 Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti’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. Acasti’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. Acasti’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.acasti.com or 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 Acasti 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 Acasti'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 Acasti'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 Acasti 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. Acasti 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: Acasti Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email: info@acastipharma.com www.acasti.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

Phase 1Orphan DrugAcquisitionNDA

30 Sep 2024

·www.pharmaceutical-technology.com

LEO Pharma announces Enstilar NDA submission for plaque psoriasis in China

The review process is set for completion in H1 2026. Credit: Hriana via Shutterstock. Leo Pharma has submitted a New Drug Application (NDA) to China’s National Medical Products Administration for Enstilar, targeting the treatment of adult patients with plaque psoriasis. Enstilar is an aerosol spray foam combining calcipotriol and betamethasone, designed to improve upon the existing Daivobet ointment, which is currently a standard treatment in China. The submission follows a series of milestones for LEO Pharma in the EU and the US, with China potentially becoming the largest market for Enstilar. The NDA is supported by a Phase III trial involving 604 adult Chinese subjects with stable plaque psoriasis. This trial showed Enstilar to be superior to Daivobet ointment, achieving both primary and secondary endpoints. See Also: FDA approves PureTech’s KarXT to treat schizophrenia in adults FDA greenlights Regeneron’s Dupixent for the treatment of COPD The Center for Drug Evaluation (CDE) in China will now validate and fully evaluate the NDA. The regulatory review process is anticipated to be completed in the first half (H1) of 2026. LEO Pharma China general manager Byron Yin said: “LEO Pharma strives to enhance patient care and elevate quality of life for those living with complex skin conditions like plaque psoriasis. “Today’s submission is a crucial step towards offering a much-needed new treatment option in our region, in addition to the existing portfolio offering from LEO Pharma China.” Enstilar is already indicated in the EU for up to four weeks of treatment for psoriasis vulgaris in adults, with suitable candidates eligible for long-term maintenance. Recently, the European Commission authorised Leo Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema .

Phase 3NDAClinical ResultDrug Approval

100 Deals associated with Betamethasone

External Link

KEGG	Wiki	ATC	Drug Bank
D00244	Betamethasone	D07XC01 A07EA04 R01AD06	DB00443

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Erythematosus, Discoid	GB	Organon & Co.	03 Jun 2021
Prurigo	PT	Organon & Co.	03 Jun 2021
Prurigo	GB	Organon & Co.	03 Jun 2021
Psoriasis	NL	Organon & Co.	03 Jun 2021
Psoriasis	SE	Organon & Co.	03 Jun 2021
Psoriasis	TW	Organon & Co.	03 Jun 2021
Psoriasis	GB	Organon & Co.	03 Jun 2021
Colitis, Ulcerative	JP	Shionogi & Co., Ltd.	04 Jun 1981
Lupus Erythematosus, Cutaneous	CN	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Dermatitis	JP	Takada Corp.	20 Oct 1964
Drug Eruptions	JP	Takada Corp.	20 Oct 1964
Rhinitis, Allergic	JP	Takada Corp.	20 Oct 1964
Urticaria	JP	Takada Corp.	20 Oct 1964
Asthma	JP	Shionogi Pharma, Inc.	12 Dec 1961
Collagen Diseases	JP	Shionogi Pharma, Inc.	12 Dec 1961
Endocrine System Diseases	JP	Shionogi Pharma, Inc.	12 Dec 1961
Heart Failure	JP	Shionogi Pharma, Inc.	12 Dec 1961
Hematologic Diseases	JP	Shionogi Pharma, Inc.	12 Dec 1961
Nephrotic Syndrome	JP	Shionogi Pharma, Inc.	12 Dec 1961
Rheumatoid Arthritis	JP	Shionogi Pharma, Inc.	12 Dec 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ataxia Telangiectasia	Phase 2	-	Grace Therapeutics, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MP11-16 (AUA2024)	Not Applicable	Chronic prostatitis	45	Betamethasone injection	tmrxzmycsu(kwddbupwye) = Improvement in IIEF questionnaire scores hasmruujyl (lvnftmhkxj ) View more	Positive	01 May 2024
WCD2023	Not Applicable	Keloid	16	Intralesional injections of 5-FU, betamethasone, hyaluronidase	bexeglsnxa(ebbptsuhzq) = prxvnmbkcx oiwmibivth (itmndrmnbn )	Positive	03 Jul 2023
NCT04900220 (CTgov)	Phase 4	Arthus Reaction \| Trigger Finger Disorder	66	Betamethasone (Betamethasone)	rffivzmgwr(vjenkpcbhw) = srcsibviyw vejzusdizg (yiaebjdklc, himssxjnrb - xrjjuymnub) View more	-	23 Jun 2023
				Methylprednisolone (Methylprednisolone)	rffivzmgwr(vjenkpcbhw) = bfanqxtvqq vejzusdizg (yiaebjdklc, vveopamjrg - chjbxszenj) View more
NCT02038634 (CTgov)	Phase 4	Thyroiditis, Subacute	16	Betamethasone (Unguided Injections)	cmsaccrtlh(rxmepwjroi) = ljewvwomzd nyjxzpptih (nhbpnxknrb, leqtospprv - pmhpfzymyz) View more	-	28 Dec 2022
				Ultrasound+Betamethasone (Ultrasound-guided Injections)	cmsaccrtlh(rxmepwjroi) = iddnrtehsm nyjxzpptih (nhbpnxknrb, uyskvcaigf - gxjcbkeqlc) View more
ARVO2022	Not Applicable	-	-	Ziclor P gel	vnbrfhfxdy(zjvowxskoz) = ATP levels were significantly (p<0.05) reduced by the three formulations exposure compared to the new gel Ziclor P bryjkbbjke (wboiokdulz ) View more	-	01 May 2022
				Ducressa eye-drops
NCT04420572 (CTgov)	Not Applicable	Greater Trochanteric Pain Syndrome	63	ozone injection (Ozone Injection Group)	sqzgalimxn(khjlbslgkt) = ledluuwjhc itaixntoet (bdhcdmeaqq, zedugbtwiw - uovoptybzl) View more	-	21 Oct 2021
				betamethasone (Steroid Injection Group)	sqzgalimxn(khjlbslgkt) = kjfyszaian itaixntoet (bdhcdmeaqq, kapgixhjep - arbyqjutmg) View more
NCT00669383 (CTgov)	Not Applicable	Respiratory Insufficiency	85	A (Betamethasone) (A (Betamethasone))	mjjmfrahyq(ffwyqptaoh) = dghtekvuqq chwykwugen (bzjzcbutib, ipxufbdcrw - ffhvqvmmww) View more	-	22 Feb 2019
				Placebo (B (Placebo))	mjjmfrahyq(ffwyqptaoh) = hgrltahcar chwykwugen (bzjzcbutib, orglaptptt - twjnggkqhd) View more
NCT01222247 (ALPS, CTgov)	Phase 3	Pregnancy \| Respiratory Distress Syndrome \| Obstetric Labor, Premature	2,831	betamethasone (Betamethasone)	fehlzhyrdl(tfarortuzd) = ssroecjlne lvagrewjvq (cgnalkfrne, tqrxzewsir - khlwwdczzu) View more	-	30 Jan 2019
				Placebo (Placebo)	fehlzhyrdl(tfarortuzd) = qumuflxkup lvagrewjvq (cgnalkfrne, pegrkvraiz - hnxjeebmey) View more
ESPE2018	Not Applicable	Hypoglycemia	128	Antenatal Steroids	dnrybgvhjd(dciwenkeny) = xtzzigmfsx urtaztddez (vjlpsnlywy )	-	27 Sep 2018
				No Antenatal Steroids	dnrybgvhjd(dciwenkeny) = gapalsakyu urtaztddez (vjlpsnlywy )
AAAAI2018	Not Applicable	-	-	Dexamethasone	qktuxhmeqi(oxbhixzsyx) = 3 tcbutwsrav (rxnzjkvztf ) View more	-	01 Feb 2018
				Hydrocortisone

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