A Phase II, Randomized, Multi-center, Placebo-controlled, Double-blind Study to Investigate the Safety of GS-248, and Efficacy on Raynaud's Phenomenon (RP) and Peripheral Vascular Blood Flow, in Subjects With Systemic Sclerosis (SSc)

The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).

Start Date29 Dec 2020

Sponsor / Collaborator

Gesynta Pharma ABStartup

[+1]

EUCTR2020-002081-13-GB

/ Unknown statusPhase 2

A Phase II, randomised, multi-centre placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud’s phenomenon (RP) and peripheral vascular blood flow in patients with systemic sclerosis (SSc)

Start Date08 Sep 2020

Sponsor / Collaborator

Gesynta Pharma ABStartup

NCT04617509

/ CompletedPhase 1

An Open, One-sequence, Three-period Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Oral Single Dosing of Two Different Solid Formulations of GS-248

The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects. It will also collect information about pharmacokinetics (PK), safety and tolerability following a single dose of one of the two formulations of GS-248 in fed condition.

Start Date31 Mar 2020

Sponsor / Collaborator

Gesynta Pharma ABStartup

[+1]

100 Clinical Results associated with Vipoglanstat

100 Translational Medicine associated with Vipoglanstat

100 Patents (Medical) associated with Vipoglanstat

Literatures (Medical) associated with Vipoglanstat

01 Feb 2025·Rheumatology

A phase 2 trial investigating the efficacy and safety of the mPGES-1 inhibitor vipoglanstat in systemic sclerosis-related Raynaud's

Article

Author: Korkosz, Mariusz ; Tornling, Göran ; Kowalski, Jan ; Del Galdo, Francesco ; Olas, Jacek ; Hall, Frances ; Olsson, Anna ; Edenius, Charlotte ; Wojteczek, Anna ; Bhat, Smita ; Murray, Andrea ; Herrick, Ariane L ; Smith, Vanessa ; van Laar, Jacob M ; Vonk, Madelon C ; Krasowska, Dorota ; Pauling, John D ; Anderson, Marina ; Denton, Christopher P

AbstractObjectiveOur objective was to test the hypothesis, in a double-blind, placebo-controlled study that vipoglanstat, an inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), which decreases prostaglandin E2 (PGE2) and increases prostacyclin biosynthesis, improves RP.MethodsPatients with SSc and ≥7 RP attacks during the last screening week prior to a baseline visit were randomized to 4 weeks treatment with vipoglanstat 120 mg or placebo. A daily electronic diary captured RP attacks (duration and pain) and Raynaud’s Condition Score, with change in RP attacks/week as the primary end point. Cold challenge assessments were performed at baseline and end of treatment. Exploratory end points included patients’ and physicians’ global impression of change, Assessment of Scleroderma-associated Raynaud’s Phenomenon questionnaire, mPGES-1 activity, and urinary excretion of arachidonic acid metabolites.ResultsSixty-nine subjects received vipoglanstat (n = 33) or placebo (n = 36). The mean weekly number of RP attacks [baseline; vipoglanstat 14.4 (S.D. 6.7), placebo 18.2 (12.6)] decreased by 3.4 (95% CI –5.8; –1.0) and 4.2 (–6.5; –2.0) attacks per week (P = 0.628), respectively. All patient-reported outcomes improved, with no difference between the groups. The mean change in recovery of peripheral blood flow after the cold challenge did not differ between the study groups. Vipoglanstat fully inhibited mPGES-1, resulting in 57% reduction of PGE2 and 50% increase of prostacyclin metabolites in the urine. Vipoglanstat was safe and well tolerated.ConclusionAlthough vipoglanstat was safe, and well tolerated in a dose achieving full inhibition of mPGES-1, it was ineffective in SSc-related RP. Further development and evaluation of vipoglanstat will therefore be in other diseases where mPGES-1 plays a pathogenetic role.Trial registrationClinicalTrials.gov, https://www.clinicaltrials.gov, NCT0474420.

01 Dec 2021·Journal of Translational MedicineQ2 · MEDICINE

Inhibition of microsomal prostaglandin E synthase-1 ameliorates acute lung injury in mice

Q2 · MEDICINE

ArticleOA

Author: Doods, Henri ; Rampa, Dileep Reddy ; Wu, Dongmei ; Nasseri, Saeed ; Pekcec, Anton ; Feng, Huiying ; Lee, Dongwon ; Gurusamy, Malarvizhi

AbstractBackgroundTo examine the effects of BI 1029539 (GS-248), a novel selective human microsomal prostaglandin E synthase-1 (mPGES-1) inhibitor, in experimental models of acute lung injury (ALI) and sepsis in transgenic mice constitutively expressing the mPGES1 (Ptges) humanized allele.MethodsSeries 1: Lipopolysaccharide (LPS)-induced ALI. Mice were randomized to receive vehicle, BI 1029539, or celecoxib. Series 2: Cecal ligation and puncture-induced sepsis. Mice were randomized to receive vehicle or BI 1029539.ResultsSeries 1: BI 1029539 or celecoxib reduced LPS-induced lung injury, with reduction in neutrophil influx, protein content, TNF-ɑ, IL-1β and PGE2 levels in bronchoalveolar lavage (BAL), myeloperoxidase activity, expression of mPGES-1, cyclooxygenase (COX)-2 and intracellular adhesion molecule in lung tissue compared with vehicle-treated mice. Notably, prostacyclin (PGI2) BAL concentration was only lowered in celecoxib-treated mice. Series 2: BI 1029539 significantly reduced sepsis-induced BAL inflammatory cell recruitment, lung injury score and lung expression of mPGES-1 and inducible nitric oxide synthase. Treatment with BI 1029539 also significantly prolonged survival of mice with severe sepsis. Anti-inflammatory and anti-migratory effect of BI 1029539 was confirmed in peripheral blood leukocytes from healthy volunteers.ConclusionsBI 1029539 ameliorates leukocyte infiltration and lung injury resulting from both endotoxin-induced and sepsis-induced lung injury.

01 Dec 2019·The FASEB JournalQ2 · BIOLOGY

Inhibition of human microsomal PGE2 synthase‐1 reduces seizure‐induced increases of P‐glycoprotein expression and activity at the blood‐brain barrier

Q2 · BIOLOGY

Article

Author: Kryscio, Richard J. ; Bauer, Björn ; Pekcec, Anton ; Akanuma, Shin‐Ichi ; Soldner, Emma L. B. ; Hosoya, Ken‐Ichi ; Hartz, Anika M. S. ; Doods, Henri

The cause of antiseizure drug (ASD) resistance in epilepsy is poorly understood. Here, we focus on the transporter P‐glycoprotein (P‐gp) that is partly responsible for limited ASD brain uptake, which is thought to contribute to ASD resistance. We previously demonstrated that cyclooxygenase‐2 (COX‐2) and the prostaglandin E receptor, prostanoid E receptor subtype 1, are involved in seizure‐mediated P‐gp up‐regulation. Thus, we hypothesized that inhibiting microsomal prostaglandin E2 (PGE2) synthase‐1 (mPGES‐1), the enzyme generating PGE2, prevents blood‐brain barrier P‐gp up‐regulation after status epilepticus (SE). To test our hypothesis, we exposed isolated brain capillaries to glutamate ex vivo and used a combined in vivo‐ex vivo approach by isolating brain capillaries from humanized mPGES‐1 mice to study P‐gp levels. We demonstrate that glutamate signaling through the NMDA receptor, cytosolic phospholipase A2, COX‐2, and mPGES‐1 increases P‐gp protein expression and transport activity levels. We show that mPGES‐1 is expressed in human, rat, and mouse brain capillaries. We show that BI1029539, an mPGES‐1 inhibitor, prevented up‐regulation of P‐gp expression and transport activity in capillaries exposed to glutamate and in capillaries from humanized mPGES‐1 mice after SE. Our data provide key signaling steps underlying seizure‐induced P‐gp up‐regulation and suggest that mPGES‐1 inhibitors could potentially prevent P‐gp up‐regulation in epilepsy.—Soldner, E. L. B., Hartz, A. M. S., Akanuma, S.‐I., Pekcec, A., Doods, H., Kryscio, R. J., Hosoya, K.‐I., Bauer, B. Inhibition of human microsomal PGE2 synthase‐1 reduces seizure‐induced increases of P‐glycoprotein expression and activity at the blood‐brain barrier. FASEB J. 33, 13966‐13981 (2019). www.fasebj.org

News (Medical) associated with Vipoglanstat

06 Feb 2025

·orexo.com

Orexo Interim Report Q4 2024, incl. Full Year Report

Q4 2024 highlights › Total net revenues of SEK 160.3 m (166.0) › EBITDA of SEK 28.9 m (12.4) › Impairment of intangible assets Deprexis® of SEK 71.1 m (0) and Vorvida® of SEK 28.1 m (0) › Net earnings of SEK -116.2 m (-18.6), adjusted net earnings amounted to SEK -18.9 m (-18.6) › US Commercial segment net revenues of SEK 152.1 m (151.3), in local currency USD 14.1 m (14.2) › Cash flow from operating activities of SEK 6.2 m (-2.6), cash and cash equivalents of SEK 123.3 m (171.0) › Earnings per share before and after dilution amounted to SEK -3.37 (-0.54) › Orexo agreed with GAIA on terminating the partnership for Deprexis ›Friedrich von Bohlen und Halbach elected as new board member at an Extraordinary General Meeting ›Patent litigation against Sun Pharmaceutical Industries reagarding Zubsolv® in the US was resolved ›Collaboration entered with Abera Bioscience to develop nasal powder vaccines based on the drug delivery technology AmorphOX® ›Financial outlook for 2025 on page 16. Important events after the end of the period ›Positive topline data showed from clinical study of OX640, a nasal powder-based adrenaline product, in participants with allergic rhinitis ›Future rights to royalties for OX-MPI, a new treatment for endometriosis, converted to shares in Gesynta Pharma valued at SEK 19 m and recognized in Q4 2024. CEO Comments in Brief: Resolving issues, unlocking more flexibility We end 2024 with an intense fourth quarter. The settlement in the patent litigation for Zubsolv® was an important milestone which in combination with continued stable revenue from Zubsolv gives us confidence that Zubsolv US will be an important contributor to our financial stability and ability to finance investments in other growth drivers. With the settlement we can start the process to clean the table and set a strategy to drive the long-term growth and shareholder value. Operationally, we saw mixed developments during the quarter. The timeline for OX124, our overdose rescue medication, has been extended, primarily due to delivery delays of components from one of our subcontractors. For OX640, our promising nasal drug for the treatment of anaphylaxis, we completed the second clinical study in December, this time in patients with allergic rhinitis. I am pleased with the successful data from the study, which further underscores that we have an exciting asset in our pipeline. Thanks to the AmorphOX technology we once again managed to show excellent bioavailability and we are confident OX640 will be a product with clear competitive advantages. Uppsala, Sweden, February 6, 2025 Nikolaj Sørensen President and CEO To read full version of CEO Comments see PDF. Contact persons quarterly report: Nikolaj Sørensen, President and CEO Fredrik Järrsten, EVP and CFO Lena Wange, IR & Communications Director Tel: +46 18 780 88 00, +1 855 982 7658, E-mail: ir@orexo.com. Presentation On Feburary 6, at 2 pm CET analysts, investors and media are invited to attend a presentation, incl. a Q&A. To attend via teleconference where you can ask questions verbally: https://conference.financialhearings.com/teleconference/?id=5007431 When registered you will be provided phone numbers and a conference ID to access the conference. To attend via webcast: https://orexo.events.inderes.com/q4-report-2024 Prior to the call, presentation material will be available on the website under Investors/Rapport archive

VaccineFinancial Statement

29 Jan 2025

·www.prnewswire.com

Endometriosis Clinical Trial Pipeline Gains Momentum as 15+ Key Companies at the Forefront | DelveInsight

Approximately 10% of women of reproductive age worldwide are affected by endometriosis, equating to about 190 million individuals. This substantial patient population necessitates effective treatments, propelling market demand this increasing disease prevalence is driving the market for endometriosis. LAS VEGAS, Jan. 29, 2025 /PRNewswire/ -- DelveInsight's ' Endometriosis Pipeline Insight 202 5 ' report provides comprehensive global coverage of pipeline endometriosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the endometriosis pipeline domain. Key Takeaways from the Endometriosis Pipeline Report DelveInsight's endometriosis pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for endometriosis treatment. Key endometriosis companies such as Kissei Pharmaceutical, Mithra Pharmaceuticals, Gesynta Pharma, Jiangsu Hengrui Medicine Co., Ferring Pharmaceuticals, Hope Medicine (Nanjing) Co., Ltd, VaRi Bioscience, SWK Holdings, Ananda Developments, TiumBio, Ironwood Pharmaceuticals, Chugai Pharmaceutical, Viramal, Organon, Mitsubishi Tanabe Pharma, Antev, Foraviset, ValiRx, EpicentRx, Temple Therapeutics, Celmatix, BCI Pharma, Gynica, PrecisionLife, Flightpath Biosciences, and others are evaluating new endometriosis drugs to improve the treatment landscape. Promising endometriosis pipeline therapies such as Linzagolix, Estelle, Vipoglanstat, SHR7280, Quinagolide, HMI-115, VR103, Ovarest, MRX1, TU2670, IW-3300, AMY-109, VML 0501, OG-6219, Teverelix trifluoroacetate, Raviset, VAL301, Nibrozetone, TTX334e, IntraVagS302, IntraVagS301, FP-300, and others are under different phases of endometriosis clinical trials. In October 2024, Lisata Therapeutics, Inc. announced that it has entered into a sponsored research agreement with the University of Cincinnati to investigate Lisata's novel cyclic peptide product candidate, certepetide, in combination with bevacizumab (a VEGF inhibitor) in a preclinical animal model for the treatment of endometriosis. In October 2024, Hope Medicine Inc. announced positive results from an interim analysis of a global Phase II 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. In May 2024, Neurocrine Biosciences, Inc. announced the initiation of its Phase I first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions. In May 2024, TiumBio Co., Ltd. focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced positive topline results from its Phase 2a clinical trial of Merigolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in patients with moderate to severe endometriosis-associated pain. Request a sample and discover the recent advances in endometriosis treatment drugs @ Endometriosis Pipeline Report The endometriosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage endometriosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the endometriosis clinical trial landscape. Endometriosis Overview Endometriosis is a condition where tissue similar to the endometrium, which lines the uterus, grows outside of it. This often occurs in the lower abdomen or pelvic region but can occasionally be found elsewhere in the body. It commonly causes pelvic pain and may lead to infertility. The condition can begin with a person's first menstrual cycle and persist until menopause. The exact cause of endometriosis remains unknown, and there is currently no way to prevent it. While there is no cure, symptoms can be managed through medications or, in some cases, surgery. Not all individuals with endometriosis experience symptoms, but common ones include pelvic pain, painful periods, discomfort during sexual intercourse, and challenges with conception. Approximately 10% of women of reproductive age are affected, though the true prevalence is difficult to determine as diagnosis often requires laparoscopic surgery to confirm the presence of lesions. Endometriosis is a complex and widespread condition affecting women worldwide, regardless of ethnicity or social status. It is believed to result from multiple factors, including retrograde menstruation and cellular metaplasia, where cells outside the uterus transform into endometrial-like tissue. The condition is also heavily influenced by estrogen, which promotes inflammation, growth, and pain associated with the disease. Diagnosing endometriosis typically involves assessing a patient's menstrual and pelvic pain history. Although various diagnostic tools have been proposed, none are fully validated to identify individuals with certainty. Symptoms can mimic other conditions, leading to diagnostic delays. Imaging techniques like ultrasonography or MRI may be used to detect ovarian endometriomas, adhesions, or deep nodular lesions. Histologic confirmation, often following laparoscopic visualization, helps confirm the diagnosis but should not delay the initiation of empirical medical treatment. Treatment options range from conservative approaches, such as non-steroidal anti-inflammatory drugs (e.g., ibuprofen) to manage pain, to hormone-based medications that help control symptoms. Surgical intervention can both diagnose and treat endometriosis, with procedures to remove or destroy lesions and scar tissue, potentially alleviating pain and restoring normal pelvic anatomy. Find out more about endometriosis treatment drugs @ Drugs for Endometriosis Treatment A snapshot of the Endometriosis Pipeline Drugs mentioned in the report: Learn more about the emerging endometriosis pipeline therapies @ Endometriosis Clinical Trials Endometriosis Therapeutics Assessment The endometriosis pipeline report proffers an integral view of the endometriosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Endometriosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Monoclonal antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: LHRH receptor antagonists, Estrogen receptor agonists, Hormone replacements, Mineralocorticoid receptor antagonists, Progesterone receptor agonists, Testosterone congener inhibitors, Prostaglandin-E synthase inhibitors, Gonadotropin-releasing hormone inhibitors, Dopamine D2 receptor agonists, Prolactin receptor antagonists, Key Endometriosis Companies: Kissei Pharmaceutical, Mithra Pharmaceuticals, Gesynta Pharma, Jiangsu Hengrui Medicine Co., Ferring Pharmaceuticals, Hope Medicine (Nanjing) Co., Ltd, VaRi Bioscience, SWK Holdings, Ananda Developments, TiumBio, Ironwood Pharmaceuticals, Chugai Pharmaceutical, Viramal, Organon, Mitsubishi Tanabe Pharma, Antev, Foraviset, ValiRx, EpicentRx, Temple Therapeutics, Celmatix, BCI Pharma, Gynica, PrecisionLife, Flightpath Biosciences, and others. Key Endometriosis Pipeline Therapies: Linzagolix, Estelle, Vipoglanstat, SHR7280, Quinagolide, HMI-115, VR103, Ovarest, MRX1, TU2670, IW-3300, AMY-109, VML 0501, OG-6219, Teverelix trifluoroacetate, Raviset, VAL301, Nibrozetone, TTX334e, IntraVagS302, IntraVagS301, FP-300 and others. Dive deep into rich insights for new drugs for endometriosis treatment, visit @ Endometriosis Drugs Table of Contents For further information on the endometriosis pipeline therapeutics, reach out @ Endometriosis Treatment Drugs Related Reports Endometriosis Market Endometriosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key endometriosis companies including AbbVie, Neurocrine Biosciences, ObsEva, Kissei Pharmaceuticals, SWK, Enteris BioPharma, Bayer, Hope Medicine, Tiumbio, Organon, among others. Endometriosis Epidemiology Forecast Endometriosis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted endometriosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Endometriosis Pain Market Endometriosis Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. Endometriosis Pain Pipeline Endometriosis Pain Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultBreakthrough TherapyPhase 1

20 Jan 2025

·orexo.com

Orexo converts future rights for OX-MPI to shares in Gesynta Pharma valued at SEK 19 million

Uppsala, Sweden – January 20, 2025 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces that rights to future transaction proceeds and royalty on future net revenues for the drug candidate vipoglanstat (OX-MPI), have been converted to shares in Gesynta Pharma AB (“Gesynta”). The transaction took place in connection with Gesynta's recent capital raise and Orexo’s shares are valued at SEK 19.2 million. The value generated will be recognized under other operating income in Orexo’s Q4, 2024 results. In 2017, Orexo and Gesynta entered into a purchase agreement under which Gesynta acquired all assets related to OX-MPI, with the intention of developing the drug candidate. In return, Orexo was entitled to receive share of future transaction proceeds and royalty on future net revenues generated from the program. With successful fundraising, Gesynta will now proceed with development of vipoglanstat in a phase II clinical trial. The drug candidate has the potential to revolutionize the treatment of the inflammatory disease endometriosis, which affects 190 million women worldwide. Nikolaj Sørensen, CEO and President of Orexo AB said: “We are pleased to see the support from investors to Gesynta and the continued development of vipoglanstat. The early data from vipoglanstat is impressive and the drug candidate has the potential to help millions of women worldwide living with the chronic disease endometriosis. Orexo looks forward to continue as a shareholder in Gesynta and this transaction is fully in line with our objective of strengthening the Orexo financial results and equity position.” For further information contact: Orexo AB (publ.) Nikolaj Sørensen, President and CEOLena Wange, IR & Communications DirectorTel: +46 18 780 88 00E-mail: ir@orexo.com About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2023 amounted to SEK 639 million, and the number of employees to 116. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US. For more information about Orexo please visit www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube. About Gexynta Pharma Gesynta Pharma is a clinical-stage pharmaceutical company developing innovative treatments by targeting mPGES-1, a key enzyme in inflammatory processes. Gesynta Pharma's research originated at Karolinska Institutet in Sweden. The lead compound, vipoglanstat, is being developed for the treatment of endometriosis – a painful chronic inflammatory disease that affects about 10 percent of women of reproductive age. Endometriosis often leads to a severely reduced quality of life and current drug treatments are inadequate for many patients, partly due to troublesome side effects. Vipoglanstat is a non-hormonal, non-opioid, disease-modifying drug candidate that selectively inhibits mPGES-1; it has demonstrated a favorable safety profile and potent inhibition of mPGES-1 in Phase I and II clinical trials. A preclinical proof-of-concept study in an advanced disease model of endometriosis shows that vipoglanstat significantly reduces endometrial lesions and positively impacts pain-related parameters and well-being. A Phase II clinical trial in patients with endometriosis is expected to start in 2025. A second drug candidate in the Gesynta Pharma portfolio, GS-073, is ready to enter clinical Phase I for the treatment of chronic inflammatory pain. The company's shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, and other internationally renowned specialist investors. For more information, please visit www.gesynta.se. The information was submitted for publication, through the agency of the contact persons set out above, at 8.45 CEST on January 20, 2025.

Phase 2Phase 1Acquisition

100 Deals associated with Vipoglanstat

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Endometriosis	Phase 2	Sweden	Orexo AB	-
Endometriosis	Phase 2	-	Orexo AB	-
Raynaud Disease	Preclinical	Belgium	Gesynta Pharma ABStartup	29 Dec 2020
Raynaud Disease	Preclinical	United Kingdom	Gesynta Pharma ABStartup	29 Dec 2020
Raynaud Disease	Preclinical	Poland	Gesynta Pharma ABStartup	29 Dec 2020
Raynaud Disease	Preclinical	Netherlands	Gesynta Pharma ABStartup	29 Dec 2020
Scleroderma, Systemic	Preclinical	Poland	Gesynta Pharma ABStartup	29 Dec 2020
Scleroderma, Systemic	Preclinical	Netherlands	Gesynta Pharma ABStartup	29 Dec 2020
Scleroderma, Systemic	Preclinical	Belgium	Gesynta Pharma ABStartup	29 Dec 2020
Scleroderma, Systemic	Preclinical	United Kingdom	Gesynta Pharma ABStartup	29 Dec 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04744207 (CTgov)	Phase 2	Raynaud Disease \| Scleroderma, Systemic \| Retinitis Pigmentosa	94	GS-248 (GS-248)	wwzorkchzh(mmxobuuteu) = oqrfdudyay jeltmcyzni (edtsoktldl, iyzpcnwvmq - hoxagvjzqh) View more	-	09 Aug 2024
				Placebo (Placebo)	wwzorkchzh(mmxobuuteu) = oktdfmumlo jeltmcyzni (edtsoktldl, rwstjtrdfd - vdmgsfjqmj) View more
NCT04617509 (CTgov)	Phase 1	-	14	Formulation A GS-248 (Part I GS-248 Formulation A)	(tebyjgqijc) = znhquihzof ygkhkqkprx (ftpkoblnkj, okedosnndt - yyuvmurmpv) View more	-	31 Aug 2021
				Formulation B GS-248 (Part I GS-248 Formulation B)	(tebyjgqijc) = znxzejamlq ygkhkqkprx (ftpkoblnkj, ukkjeifwfm - euocxcljzn) View more

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