In this prospective active-controlled randomized trial the investigators will assess for the first time ever the different local treatments of vulvovaginal atrophy in breast cancer patients on endocrine therapy. These patients are currently inadequately treated based on ignorance of possible treatment modalities and stigmatization of vulvovaginal atrophy.

Start Date21 Mar 2022

Sponsor / Collaborator

Ghent University Hospital

[+1]

NCT05246865 / RecruitingNot ApplicableIIT

The Role of 11-oxygenated Androgens in Androgen Excess and Metabolic Dysfunction of Women With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) affects 10% of all women and usually presents with irregular menstrual periods and difficulties conceiving. It is also a lifelong metabolic disorder and affected women have an increased risk of type 2 diabetes, high blood pressure, and heart disease. Increased blood levels of male hormones, also termed androgens, are found in most PCOS patients. Androgen excess appears to impair the ability of the body to respond to the sugar-regulating hormone insulin (also termed 'insulin resistance'). Androgens circulating in the blood in women with PCOS are comprised of classic androgens (for example testosterone), and the less-characterised 11-oxygenated androgen subclass that arises from the adrenal glands. The investigators have recently demonstrated that 11-oxygenated androgens make up the majority of circulating androgens in women with PCOS.
In preliminary studies using minimally invasive adipose tissue sampling, the investigators have found that the fat tissue of women with PCOS overproduces classic androgens. This can lead directly to disturbances in the ability of fat cells to store fat effectively (lipotoxicity), resulting in insulin resistance and the consequent risk of liver damage. However, there are no published studies on in vivo androgen concentrations in the adipose tissue of women with PCOS. Furthermore, the scientific community do not have any information on whether adipose concentrations of 11-oxygenated androgens are also increased in women with PCOS.
Research Questions The investigators aim to examine the metabolism of classic and 11-oxygenated androgens in detail in both circulations and in the adipose tissue of women with PCOS. The investigators will examine how precursor variants of both 11-oxygenated and classic androgens, which are converted by the body into active hormones, are broken down (metabolised) within the adipose tissue of women with PCOS. The investigators will also investigate if the 11-oxygenated androgens have a differential impact on metabolic function as compared to classic androgens. This will give important insights into the adipose tissue metabolome in women with PCOS, and how locally generated androgens impact on adipose tissue function and metabolic risk.

Start Date10 Oct 2021

Sponsor / Collaborator

University of Birmingham

100 Clinical Results associated with Prasterone

100 Translational Medicine associated with Prasterone

100 Patents (Medical) associated with Prasterone

8,530

Literatures (Medical) associated with Prasterone

31 Dec 2024·Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology

Comparative effects of the antioxidant glutathione with metformin and Diane-35 on hormonal, metabolic, and inflammatory indicators in a DHEA-induced PCOS rat model

Article

Author: Tanoglu, Fatma Basak ; Tok, Olgu Enis ; Timur, Hikmet Tunç ; Özkara, Gülçin ; Coşar, Aslı ; Çetin, Çağlar ; Neccar, Duygu ; Özcan, Pınar

OBJECTIVE:

Comparison of hormonal, metabolic and inflammatory markers of glutathione with metformin and Diane-35 in a rat model of PCOS induced by dehydroepiandrosterone.

METHODS:

Twenty-five female rats were randomized into four groups. Group 1 was administered a subcutaneous dose of 0.2 ml saline/day. Group 2 was given 0.2 ml of 1% carboxymethyl cellulose (CMC)/day orally for 28 days. A PCOS model was established with DHEA in rats. Group 3 was given 4.5 mg/kg/day of Diane-35 orally dissolved in 1% CMC for 28 days. Group 4 was given 300 mg/kg/day of metformin orally dissolved in 1 ml of saline for 28 days, and Group 5 was administered 100 mg/kg of glutathione intraperitoneally on days 35, 42, and 49. On day 56, the rats were sacrificed. Serum markers and follicle count were examined.

RESULTS:

Serum IL-6, hs-CRP, insulin, testosterone, SHBG, and MDA values were significantly lower in the glutathione group than in the PCOS group (p = 0.0006, p = 0.023, p = 0.0082, p = 0.0007, p = 0.0048, and p < 0.0001, respectively).The number of all follicles was similar between the control and glutathione groups (p < 0.05). When we compared the other groups with the PCOS group, the number of primary, secondary, atretic, and cystic follicles was significantly lower in the metformin and glutathione groups. The number of primordial and antral follicles was significantly higher than in the PCOS group.

CONCLUSIONS:

Glutathione plays anti-inflammatory and antioxidant roles, similar to metformin, by lowering serum IL-6, insulin, testosterone, CRP, and MDA levels; decreasing atretic/cystic follicle count; and improving antral follicle count and folliculogenesis in PCOS patients.

01 Apr 2024·Journal of affective disorders

Testosterone synthesis was inhibited in the testis metabolomics of a depression mouse model

Article

Author: Dong, Meixue ; Chen, Guanghui ; Li, Dongyan ; Zhang, Wenbin ; Song, Jian

INTRODUCTION:

Depression is a common emotional disorder. Previous studies have suggested that depression is associated with the central nervous system. Recent studies have suggested that reduced testosterone level is the core inducement of depression. Testis is the vital organ for the synthesis of testosterone. How does testis mediate depression is still unknown.

OBJECTIVES:

We adopted a classical depression model of mouse caused through chronic mild stress (CMS). The metabolomics liquid chromatography-mass spectrometry was adopted to analyse the influence of CMS on testis metabolism. Then we confirmed the possible abnormal metabolism of the testis in depression mice by pathway analysis and molecular biological technique.

RESULTS:

Compared with control mice, 16 differential metabolites were found in CMS mice by multivariate statistical analysis. In comparison with control mice, CMS mice showed higher levels for campesterol, ribitol, citric acid, platelet activating factor, guanosine, cytosine and xanthine and lower levels for docosahexaenoic acid, hippuric acid, creatine, testosterone, dehydroepiandrosterone, progesterone, l-carnitine, acetyl carnitine and propionyl carnitine. The pathway analysis indicated that these differential metabolites are associated with steroid hormone synthesis, purine metabolism and phenylalanine metabolism. In addition, we also first discovered that testicular morphology in depression mice was damaged and steroid hormone synthetases (including steroidogenic acute regulatory protein and P450 cholesterol side chain cleavage) were inhibited.

CONCLUSION:

These findings may be helpful to parse molecular mechanisms of pathophysiology of depression. It also pointed out the direction to search for potential therapy schedules for male depression and provide novel insights into exploring the pathogenesis of male depression.

01 Mar 2024·Psychoneuroendocrinology

Cortisol and changes in depressive symptoms: The moderating role of DHEA

Article

Author: Doan, Stacey N ; Fuller-Rowell, Thomas E ; Davis, Alicia S

Stress is associated with activation of the hypothalamus-adrenal-axis (HPA). Cortisol, a product of the HPA, is thought to predict depression. However, to date, the majority of studies investigating the cortisol-depression relationship have been cross-sectional and results have been mixed. One possible reason for these mixed findings, may be that many studies fail to consider the moderating role of dehydroepiandosterone (DHEA), which is released alongside cortisol and is thought to serve opposing functions. Therefore, the present study investigated the main and interactive effects of cortisol and DHEA on depressive symptoms. Salivary cortisol and DHEA were measured from saliva throughout the Trier Social Stress task for N = 417 participants at baseline. Participants reported on their depressive symptoms using the Beck Depression Inventory - II at both baseline and follow up (ranging from 1-20 months post baseline; M = 11.60, SD = 5.80) as well as general demographics. The lavaan package in R (version 0.6.11; Rosseel, 2012) was used to conduct multiple regression analyses with FIML to explore the relationships between these variables. Results demonstrated no main effect of cortisol or DHEA, but did show a significant interaction with DHEA. The relations between cortisol and depressive symptoms depended on levels of DHEA such that the relationship was positive at low and negative at high levels of DHEA, with the overall interaction significant (β = -.22, p < .001, 95% CI = [-.333, -.115]). DHEA can act as a protective factor against depression when cortisol levels are high. This presents opportunities for future research on how to improve DHEA levels to potentially reduce depression.

News (Medical) associated with Prasterone

08 Jun 2023

·www.biospace.com

Cosette Pharmaceuticals Acquires Intrarosa® from Endoceutics, Inc.

Acquisition accelerates Cosette’s women’s health portfolio; with a differentiated, commercial stage, patent protected product BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Cosette Pharmaceuticals, Inc. ("Cosette"), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of the global rights to Intrarosa® from Endoceutics, Inc., a subsidiary of Endorecherche, Inc. The transaction includes 108 issued and pending patents across the globe with the latest expiring in 2033 including 3 Orange Book listed patents. Intrarosa® is currently available in almost all major markets, including the US, UK, EU, Canada, and Israel through our local partners like, Theramex, Tecnimede, Avia, Lupin (BSE: 500257), Dexcel, Labatec, Lacer, Lee’s Pharma, and Valenta; with Asian market launches in 2025. This press release features multimedia. View the full release here: Intrarosa (Photo: Business Wire) Apurva Saraf, President and CEO of Cosette stated, “This transformative acquisition further strengthens Cosette’s commitment to women’s health with a patent protected, novel drug formulation. In partnership with MSH Pharma Inc., Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa®. We look forward to expanding Cosette’s global footprint in new territories and with our existing distribution partners.” Intrarosa® is the only prescription drug providing both estrogen and androgen for the treatment of moderate-to-severe dyspareunia (a common symptom of vulvar and vaginal atrophy (VVA) due to menopause). Unlike conventional pharmacological estrogen-containing medications, the unique label of Intrarosa® differentiates it from all other hormone replacement therapies on the market today in that it does not carry a boxed safety warning on its label. There are an estimated 64 million post-menopausal women, and as many as 32 million of those women suffer from VVA symptoms just in the U.S. alone. Studies suggest that between 44 percent and 78 percent of women with VVA suffer from dyspareunia. About Cosette Pharmaceuticals, Inc.: Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in women’s health, cardiology and migraine indications. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 350+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. Follow us on LinkedIn.

AcquisitionDrug Approval

16 Feb 2023

·www.globenewswire.com

Aligos Therapeutics Presents Program Updates at the 32nd Conference of the Asian Pacific Association for the Study of the Liver

SOUTH SAN FRANCISCO, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in NASH and viral diseases, today announced that the company is delivering several oral and poster presentations at the 32nd Conference of the Asian Pacific Association for the Study of the Liver (APASL), being held Feb 15 – 19 in Taipei, Taiwan at the Taipei International Convention Center. Data is being presented for ALG-055009, Aligos’ THR-β agonist in clinical development for nonalcoholic steatohepatitis (NASH), as well as for several clinical and nonclinical stage investigational agents from its chronic hepatitis B (CHB) portfolio. “At this year’s meeting, we look forward to sharing data demonstrating that ALG-055009, our thyroid hormone receptor-beta (THR-β) agonist in development for NASH, showed promising anti-lipid effects in subjects with hyperlipidemia,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “In addition, we have several presentations which demonstrate the potentially best-in-class antiviral activity of our CAM-E compound, ALG-000184, where notable reductions in HBsAg levels have been observed with higher and longer-term dosing in subjects with HBeAg-positive CHB.” Presentation details, including summaries of data presented, follow below. Posters will be available for viewing throughout the conference for attendees and are also available on Aligos’ corporate website’s Scientific Presentations & Conferences page. NASH program Poster presentation Title: Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Multiple Ascending Oral Doses of ALG-055009, a Thyroid Hormone Receptor Beta (THR-β) Agonist for the Treatment of Non-Alcoholic Steatohepatitis (NASH), in Healthy Volunteers and Subjects with HyperlipidaemiaPresenter: Hakim Charfi, M.D., Medical Director, Biotrial, FrancePoster number: PH-025Summary: Single ascending oral doses of ALG-055009 up to 4 mg in healthy volunteers as well as multiple doses up to 1 mg for 14 days in subjects with hyperlipidemia were generally well tolerated and were not associated with clinically significant changes in thyroid hormones or cardiovascular parameters. Additionally, ALG-055009 demonstrated favorable pharmacokinetics and anti-lipid effects with dose-proportional increases in exposure. Chronic hepatitis B program Oral presentations Title: The Capsid Assembly Modulator ALG-000184 Dosed for 28 Days Was Well Tolerated and Rapidly Reduced Viral Markers in Subjects with Chronic Hepatitis B, Including HBsAg in a Subset of HBeAg Positive Subjects with Elevated Baseline ALTPresenter: Professor Ed Gane, MBChB, M.D., University of Auckland, New ZealandPresentation date/time: Thursday, February 16, 14:40 – 14:55 Taipei Standard Time (TST)Presentation location: 3F North LoungeSession title: HBV (Clinical) and HCVPresentation number: FP03-16Summary: Oral daily dosing with 10 – 300 mg of ALG-000184 for 28 days resulted in substantial declines in HBV DNA and RNA at all doses, regardless of whether subjects were HBeAg-positive or negative. HBsAg declines as high as 0.78 log10 IU/mL were seen in subjects achieving drug exposures corresponding to 300 mg for 28 days. Title: ALG-000184, a Capsid Assembly Modulator, Demonstrates Superior Antiviral Activity in Combination with Entecavir Compared to Entecavir in HBeAg Positive Subjects with Chronic Hepatitis B InfectionPresenter: Professor Jinlin Hou, M.D., Nanfang Medical University, Guangzhou, ChinaPresentation date/time: Thursday, February 16, 14:55 – 15:10 TSTPresentation location: 3F North LoungeSession title: HBV (Clinical) and HCVPresentation number: FP03-17Summary: In untreated subjects with CHB who were HBeAg-positive, ALG-000184 combined with entecavir (compared to entecavir alone) demonstrated superior antiviral activity as measured by HBV DNA and RNA reductions, as well as superior reductions in HBsAg, particularly in the 300 mg arm. These data demonstrate that ALG-000184 has best-in-class properties and a potential role in combination therapeutic regimens for CHB. Title: Preclinical Profile of ALG-125755, a GalNAc-siRNA Targeting HBVPresenter: Jin Hong, Ph.D., Aligos TherapeuticsPresentation date/time: Saturday, February 18, 11:35 – 11:50 TSTPresentation location: 3F South LoungeSession title: HBV (Basic)Presentation number: FP11-59Summary: Aligos’ Phase 1-stage siRNA candidate in development for chronic hepatitis B was designed using proprietary chemistries and exclusively licensed liver-targeting technology that may confer safety, stability, and potency advantages relative to other siRNA products. A summary of the preclinical in vitro and in vivo potency, efficacy and safety of ALG-125755 will be presented. Poster presentations Title: Effect of the Capsid Assembly Modulator (CAM) ALG-000184 on HBsAg Levels in Subjects with HBeAg Positive Chronic Hepatitis B (CHB)Presenter: Professor Jinlin Hou, Nanfang Medical University, Guangzhou, ChinaPoster number: PC-019Summary: In subjects with CHB who were HBeAg-positive, oral daily dosing for 28 days with 100 mg and 300 mg of ALG-000184 yielded rapid and profound declines in HBV DNA and RNA. Additionally, subjects achieving drug exposures corresponding to 300 mg for 28 days demonstrated HBsAg declines up to 0.78 log10 IU/mL. Title: Preclinical Antiviral, Pharmacological and Toxicological Characteristics of ALG-000184, a Prodrug of the Novel HBV Capsid Assembly Modulator ALG-001075Presenter: Andreas Jekle, Ph.D., Aligos TherapeuticsPoster number: PB-007Summary: The capsid assembly modulator ALG-001075 (of which Aligos’ CAM-E candidate ALG-000184 is a prodrug) demonstrated potent antiviral activity in cell-based assays and in a mouse model. In primary human hepatocytes, ALG-001075 was shown to functions via both mechanisms that CAMs can engage: inhibiting the encapsidation of pregenomic RNA (pgRNA) and preventing the formation of covalently closed circular DNA (cccDNA). Title: Safety, Tolerability and Pharmacokinetics (PK) of Single Ascending Doses of ALG-125755, a GalNAc-Conjugated Small Interfering RNA (siRNA), in Healthy Volunteers (HV)Presenter: Professor Ed Gane, MBChB, M.D., Auckland University, New ZealandPoster number: PPB-043Summary: In healthy volunteers, single doses of up to 200 mg of Aligos’ siRNA candidate ALG-125755 were well tolerated, and exposures increased dose-proportionally. A dose range that is predicted to achieve antiviral activity in CHB patients has been identified, at 40 – 100 mg. Title: Discovery of a Liver-Targeted PD-L1 Small Molecule Inhibitor for the Treatment of Chronic Hepatitis B and Liver CancerPresenter: Heleen Roose, Ph.D., Aligos TherapeuticsPoster number: PB-010Summary: Aligos’ small molecule liver-targeted PD-L1 inhibitor, ALG-093702, was shown to block the PD-1/PD-L1 interaction while reducing cell surface PD-L1. The compound also demonstrated similar potency to the PD-L1 antibody drug durvalumab. ALG-093702’s potential to mitigate immune-related systemic toxicity makes it a candidate for use in CHB or other indications in the liver. About AligosAligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver diseases and viral infections. Aligos is leveraging its expertise in liver and infectious diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH) and for the discovery and development of targeted antiviral therapies for coronaviruses. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and infectious disease, to rapidly advance its pipeline of potentially best-in-class molecules. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements that ALG-055009 is showing promising anti-lipid effects in subjects with hyperlipidemia and statements that with respect to Aligos’ CAM-E, ALG-000184, notable reductions in HBsAg levels have been observed with higher and longer-term dosing in subjects with HBeAg positive CHB. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic and the ongoing conflict between Russia and Ukraine. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2022 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Media ContactAmy Jobe, Ph.D.LifeSci Communications+1 315 879 8192ajobe@lifescicomms.com Investor ContactCorey Davis, Ph.D.LifeSci Advisors+1 212 915 2577cdavis@lifesciadvisors.com

Clinical ResultPhase 1siRNA

14 Feb 2023

·www.globenewswire.com

Aligos Therapeutics to Present Program Updates at the 32nd Conference of the Asian Pacific Association for the Study of the Liver

SOUTH SAN FRANCISCO, Calif., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in NASH and viral diseases, today announced that the company will deliver several oral and poster presentations at the 32nd Conference of the Asian Pacific Association for the Study of the Liver (APASL), being held Feb 15 – 19 in Taipei, Taiwan at the Taipei International Convention Center. Aligos will present data for ALG-055009, its THR-β agonist in development for nonalcoholic steatohepatitis (NASH), as well as for several clinical and nonclinical investigational agents from its chronic hepatitis B (CHB) portfolio. “At this year’s APASL meeting, we look forward to presenting data from several of our ongoing programs including ALG-055009, our thyroid hormone receptor-beta (THR-β) agonist in development for NASH for which we are conducting Phase 2-enabling activities to enable a Phase 2 filing by the end of this year,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “In addition, we are pleased to show exciting data for our CAM-E, ALG-000184, demonstrating notable reductions in HBsAg levels in patients with HBeAg-positive CHB.” Presentation details are as follows. Posters will be available for viewing throughout the conference. NASH program Poster presentation Title: Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Multiple Ascending Oral Doses of ALG-055009, a Thyroid Hormone Receptor Beta (THR-β) Agonist for the Treatment of Non-Alcoholic Steatohepatitis (NASH), in Healthy Volunteers and Subjects with HyperlipidaemiaPresenter: Hakim Charfi, M.D.Poster number: PH-025 Chronic hepatitis B program Oral presentations Title: The Capsid Assembly Modulator ALG-000184 Dosed for 28 Days Was Well Tolerated and Rapidly Reduced Viral Markers in Subjects with Chronic Hepatitis B, Including HBsAg in a Subset of HBeAg Positive Subjects with Elevated Baseline ALTPresenter: Ed Gane, MBChB, M.D.Presentation date/time: Thursday, February 16, 14:40 – 14:55 Taipei Standard Time (TST)Presentation location: 3F North LoungeSession title: HBV (Clinical) and HCVPresentation number: FP03-16 Title: ALG-000184, a Capsid Assembly Modulator, Demonstrates Superior Antiviral Activity in Combination with Entecavir Compared to Entecavir in HBeAg Positive Subjects with Chronic Hepatitis B infectionPresenter: Jinlin Hou, M.D.Presentation date/time: Thursday, February 16, 14:55 – 15:10 TSTPresentation location: 3F North LoungeSession title: HBV (Clinical) and HCVPresentation number: FP03-17 Title: A Preclinical Profile of ALG-125755, a GalNAc-siRNA Targeting HBVPresenter: Jin Hong, Ph.D.Presentation date/time: Saturday, February 18, 11:35 – 11:50 TSTPresentation location: 3F South LoungeSession title: HBV (Basic)Presentation number: FP11-59 Poster presentations Title: Effect of the Capsid Assembly Modulator (CAM) ALG-000184 on HBsAg Levels in Subjects with HBeAg Positive Chronic Hepatitis B (CHB)Presenter: Jinlin Hou, Ph.D.Poster number: PC-019 Title: Preclinical Antiviral, Pharmacological and Toxicological Characteristics of ALG-000184, a Prodrug of the Novel HBV Capsid Assembly Modulator ALG-001075Presenter: Andreas Jekle, Ph.D.Poster number: PB-007 Title: Safety, Tolerability and Pharmacokinetics (PK) of Single Ascending Doses of ALG-125755, a GalNAc-Conjugated Small Interfering RNA (siRNA), in Healthy Volunteers (HV)Presenter: Ed Gane, MBChB, M.D.Poster number: PPB-043 Title: Discovery of a Liver-Targeted PD-L1 Small Molecule Inhibitor for the Treatment of Chronic Hepatitis B and Liver CancerPresenter: Heleen Roose, Ph.D.Poster number: PB-010 About AligosAligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver diseases and viral infections. Aligos is leveraging its expertise in liver and infectious diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH) and for the discovery and development of targeted antiviral therapies for coronaviruses. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and infectious disease, to rapidly advance its pipeline of potentially best-in-class molecules. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to ALG-055009, Aligos’ plan to complete its ongoing Phase 1 study and Phase 2-enabling activities, including GLP toxicology studies, to enable a Phase 2 filing by the end of this year. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic and the ongoing conflict between Russia and Ukraine. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 2, 2022 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Media ContactAmy Jobe, Ph.D.LifeSci Communications+1 315 879 8192ajobe@lifescicomms.com Investor ContactCorey Davis, Ph.D.LifeSci Advisors+1 212 915 2577cdavis@lifesciadvisors.com

Phase 2Clinical ResultPhase 1

100 Deals associated with Prasterone

External Link

KEGG	Wiki	ATC	Drug Bank
D08409	Prasterone	G03XX01 A14AA07	DB01708

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hot Flashes	CA	Endoceutics, Inc.	06 Nov 2019
Osteoporosis	CA	Endoceutics, Inc.	06 Nov 2019
Dyspareunia	US	Millicent Oy	16 Nov 2016
Vulvovaginal atrophy	US	Millicent Oy	16 Nov 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diminished ovarian reserve	Phase 3	GB	The University of Nottingham	01 May 2012
Drug-Related Side Effects and Adverse Reactions	Phase 3	GB	The University of Nottingham	01 May 2012
Infertility	Phase 3	GB	The University of Nottingham	01 May 2012
Breast Cancer	Phase 3	US	National Cancer Institute	01 Jul 2011
Female Genital Neoplasms	Phase 3	US	National Cancer Institute	01 Jul 2011
Vaginal Discharge	Phase 3	US	National Cancer Institute	01 Jul 2011
Libido disorder NOS	Phase 3	AU	Monash University	01 Feb 2006
Menopausal syndrome	Phase 3	AU	Monash University	01 Feb 2006
Vasomotor symptom	Phase 3	AU	Monash University	01 Feb 2006
Monoclonal Gammopathy of Undetermined Significance	Phase 2	US	National Cancer Institute	01 Aug 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01256671 (CTgov)	Phase 3	Vulvovaginal atrophy	530	DHEA (prasterone)	dqjhwdnhtv(hrmtelalij) = zqpwnzdihs bfnrhuzugs (vcsvbacbnp, jpnygkckdq - ckblkdhgem) View more	-	18 Oct 2017
NCT01376349 (CTgov)	Phase 3	Vaginal Discharge \| Female Genital Neoplasms \| Breast Cancer	464	prasterone (Arm I Low Dose DHEA)	wsmpiqlwch(leevtfjrxt) = fwvruynopk jkdauxsnct (odweocivim, rvkrbrbtxh - cegcybzfod)	-	25 Aug 2017
				prasterone (Arm II High Dose DHEA)	wsmpiqlwch(leevtfjrxt) = azrcpsdykg jkdauxsnct (odweocivim, xyicmbmoni - yenmtvhndc)
NCT01358760 (CTgov)	Phase 3	Vulvovaginal atrophy	450	Placebo (Placebo)	lqwiidvglc(ibxgafbihk) = eatspabjsm whqywvdqlb (hfzyxvxgnx, vtevtnkwdu - uvivecppjv) View more	-	12 Jun 2017
				DHEA (0.25% DHEA)	lqwiidvglc(ibxgafbihk) = lvwskmupbk whqywvdqlb (hfzyxvxgnx, vnfiyktyst - gdkqnkpcvw) View more
NCT02013544 (CTgov)	Phase 3	Vulvovaginal atrophy	558	placebo	lufmprunsn(hhpdtsrekv) = ibtujrpcei xkjvuszljs (qyxjfkmbbs, rkrpxfjtpy - uszrsbqzqp) View more	-	01 Jun 2017
NCT01846442 (CTgov)	Phase 3	Vulvovaginal atrophy	218	Placebo (Placebo)	mrareihcda(tyzupkhutl) = pljovfoadz niklomohlv (qyjljjruap, rrrlkqhhwa - bvmskgouck) View more	-	28 Apr 2017
				DHEA (0.25%) (0.25% DHEA)	mrareihcda(tyzupkhutl) = sembrmfayo niklomohlv (qyjljjruap, xuidtrykyb - ngcyiordpl) View more
NCT01256684 (CTgov)	Phase 3	Vulvovaginal atrophy	255	Placebo (Placebo)	jqgqejyeiw(zwtcidaicu) = rktfgxchzo huwpbqozve (tygzsyuesx, whrxqbnsui - msxmforvpz) View more	-	25 Apr 2017
				DHEA (0.25% DHEA)	jqgqejyeiw(zwtcidaicu) = wfxxnkpdyp huwpbqozve (tygzsyuesx, zhzvtyljmd - kqeouxzggc) View more
NCT01256671 (Pubmed \| Maturitas) Manual	Phase 3	Vulvovaginal atrophy	521	Prasterone	edfihsdrxs(nkgcwmjuxv) = similar improvement results on vaginal dryness and irritation/itching. Highly significant beneficial effects (p<0.0001 versus baseline for all) at gynecological examination on vaginal secretions, color, epithelial integrity and epithelial surface thickness ltkbvhbwyu (pgyektfkhr ) View more	Positive	01 May 2015
NCT02150330 (Pubmed \| Taiwan J Obstet Gynecol)	Phase 3	Ovarian Diseases	10	DHEA supplementation	xshwcdaqih(xufowtuuom) = ohruqzngzk ezwgaqwfbq (bfeqlpzska )	-	01 Apr 2015
NCT01358760 (Pubmed \| Climacteric) Manual	Phase 3	Vulvovaginal atrophy	-	dehydroepiandrosterone	ziyftcfxhh(ibrorimhhp) = In parallel, the statistical significance over placebo (p value) on MBS vaginal dryness at 6 weeks was 0.09 followed by an increase to 0.198 at 12 weeks. bsijyefkph (szcmaxdgkb ) View more	Negative	01 Jan 2015
				Placebo
NCT02432248 (Pubmed \| PLoS One)	Not Applicable	Poor response to ovulation induction Adjuvant	386	DHEA treatment	kpjogbxdlj(jdewcoejkb) = uejixqpial ovaibakbpl (njnmvhdfee ) View more	Positive	01 Jan 2014
				dehydroepiandrosterone (Control group)	kpjogbxdlj(jdewcoejkb) = xatxuwauyc ovaibakbpl (njnmvhdfee ) View more

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