Ascites - Pipeline Insight, 2024

This “Ascites - Pipeline Insight, 2024” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Ascites pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Ascites: Understanding

Ascites: Overview

Ascites is the pathologic accumulation of fluid within the peritoneal cavity. It is the most common complication of cirrhosis and occurs in about 50% of patient with decompensated cirrhosis in 10 years. The development of ascites denotes the transition from compensated to decompensated cirrhosis. Mortality increases from complications such as spontaneous bacterial peritonitis and hepatorenal syndrome. Mortality ranges from 15% in a year to 44% in 5 years. Patients with cirrhotic ascites have a 3-year mortality rate of approximately 50%. Refractory ascites carries a poor prognosis, with a 1-year survival rate of less than 50%. Males have little intraperitoneal fluid, females have approximately 20 mL, depending on the phase of their menstrual cycle. The first abnormality that develops is portal hypertension in the case of cirrhosis. Portal pressure increases above a critical threshold and circulating nitric oxide levels increase, leading to vasodilatation. As the state of vasodilatation becomes worse, the plasma levels of vasoconstrictor sodium-retentive hormones elevate, renal function declines, and ascitic fluid forms, resulting in hepatic decompensation. Through the production of proteinous fluid by tumor cells lining the peritoneum, peritoneal carcinomatosis also can cause ascites. In high-output or low-output heart failure or nephrotic syndrome, effective arterial blood volume is decreased, and the vasopressin, renin-aldosterone, and sympathetic nervous systems are activated, leading to renal vasoconstriction and sodium and water retention.

Diagnostic abdominal paracentesis with appropriate ascitic fluid analysis is crucial for diagnosing the cause of ascites. Initial tests include blood cell count, bacterial culture, and measuring ascitic fluid protein and albumin to calculate the serum-ascites albumin gradient (SAAG). A SAAG greater or equal to 1.1 g/dL predicts portal hypertension, seen in various conditions. Additional tests like LDH, glucose, and amylase are performed based on clinical suspicion. Chest x-ray may show an elevated diaphragm, while ultrasound is sensitive for detecting ascites. CT scans can also detect ascites and masses.

Treatment of ascites is tailored to the underlying cause of fluid retention, aiming to reduce ascitic fluid volume and peripheral edema without depleting intravascular volume. Sodium restriction and diuretics are fundamental in managing ascites. For high-albumin-gradient ascites in cirrhosis, treatment includes alcohol abstinence, limited sodium intake, and diuretics. Specific therapies are essential for liver conditions like autoimmune hepatitis or chronic hepatitis B. Low-albumin-gradient ascites may require therapeutic paracentesis or specific treatments based on the cause. Therapeutic options for refractory ascites include large volume paracentesis, transjugular intrahepatic portosystemic shunt (TIPS), or liver transplantation.

"Ascites- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Ascites pipeline landscape is provided which includes the disease overview and Ascites treatment guidelines. The assessment part of the report embraces, in depth Ascites commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Ascites collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Ascites R&D. The therapies under development are focused on novel approaches to treat/improve Ascites.

Ascites Emerging Drugs Chapters

This segment of the Ascites report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Ascites Emerging Drugs

OCE-205: Ocelot Bio

Ocelot Bio’s lead asset, OCE-205, is a therapeutic peptide with a differentiated mechanism of action that has potential for improving outcomes for patients with complications of end-stage liver disease (ESLD). OCE-205’s innovation emanates from its design as a mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (v2) receptor activity at drug concentrations well above those used in treating ESLD. By virtue of its mixed V1a agonist/antagonist activity, OCE-205 treatment is designed to relieve portal hypertension while offering a capped maximal efficacy that avoids excessive vasoconstriction seen with full agonists that leads to ischemic injury and potentially other serious adverse events such as respiratory failure. By eliminating V2 activity, OCE-205 treatment is designed to avoid fluid retention and overload. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Ascites.

SCB-313: Clover Biopharmaceuticals

SCB-313 is an innovative, recombinant human TNF-related apoptosis-inducing ligand (TRAIL)-Trimer fusion protein engineered using the Trimer-Tag™ technology platform to target the extrinsic apoptosis pathway. Binding of SCB-313 to the death receptors (DR4 and DR5) leads to physiologic trimerization and potent activation of the extrinsic apoptosis pathway. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ascites.

Ascites: Therapeutic Assessment

This segment of the report provides insights about the different Ascites drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Ascites

• There are approx. 10+ key companies which are developing the therapies for Ascites. The companies which have their Ascites drug candidates in the most advanced stage, i.e. Phase II include, Ocelot Bio.

Phases

This report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Ascites pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Ascites: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Ascites therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Ascites drugs.

Ascites Report Insights

• Ascites Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Ascites Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Ascites drugs?
• How many Ascites drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Ascites?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Ascites therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Ascites and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Sichuan Clover Biopharmaceuticals
• PharmaIN
• Ocelot Bio
• Biovie
• PharmaIN

Key Products

• SCB-313
• PHIN-214
• OCE-205
• Terlipressin
• PHIN-214

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