Acromegaly-Clinical Trial Insight

Acromegaly-Clinical Trial Insight

  • DelveInsight
  • September 2020
  • Diseases & Conditions
  • 90 pages

Report Description

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DelveInsights, Acromegaly Pipeline Insight, 2020, report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Acromegaly 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
Acromegaly Understanding
Acromegaly: Overview
Acromegaly is a rare but serious condition caused by too much growth hormone (GH) in the blood. GH is released into the bloodstream by the pituitary gland, located at the base of the brain. The blood carries GH to other parts of the body where it has specific effects. In children, GH stimulates growth and development. In adults, GH affects energy levels, muscle strength, bone health, and one's sense of well-being. Too much GH in children is called gigantism and is extremely rare. Acromegaly in adults occurs mainly in middle-aged men and women. Acromegaly is a very rare condition.
Symptoms
A person with acromegaly usually has large hands and feet, thick lips, coarse facial features, a jutting forehead and jaw, and widely spaced teeth. Often people with acromegaly sweat a lot.
Other signs and symptoms fall into three categories, depending on the underlying causes. Symptoms can be caused by high GH levels, hypopituitarism (pituitary hormone deficiency caused by tumor damage to the pituitary), or by tumor volume effects (when the tumor is large enough to compress surrounding brain structures).
Diagnosis
If acromegaly is suspected, your doctor will do a blood test to check your level of IGF-1. High IGF-1 levels can mean that your levels of GH are also high.
Another way to diagnose acromegaly is with an oral glucose tolerance test. In this test, GH levels in the blood are measured after you drink sugar water. Normally, the sugar water will make the pituitary gland stop producing GH and blood levels drop. However, a GH-producing pituitary tumor will not stop making GH, so the levels of GH in the blood will not change.
Treatment
Acromegaly requires expert care. Too much GH and IGF-1 in the blood lower both your quality of life and how long you might live. The main goal of treatment is to lower GH and IGF-1 levels to normal. Treatment may be surgery, radiation therapy, medication, or a combination of these options. If the cause of acromegaly is a pituitary tumor, surgery to remove the tumor is the first treatment. Complete removal of some tumors is difficult and other types of therapy are often needed to reach normal GH and IGF-1 levels. Radiation therapy can take a long time to bring GH levels down to normal. Medication may be needed until the radiation therapy takes effect.
Acromegaly Emerging Drugs Chapters
This segment of the Acromegaly report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.
Acromegaly Emerging Drugs
CAM2029: Camurus AB
CAM2029 is developed for the treatment of acromegaly and neuroendocrine tumors. The product candidate offers important potential advantages over current marketed products, including easy administration, significantly increased bioavailability, and potential for enhanced treatment efficacy in patients for whom current treatments provide suboptimal treatment effects.CAM2029 is a ready-to-use, long-acting subcutaneous injection depot based on the active substance octreotide formulated with Camurus proprietary FluidCrystal injection depot technology. It is provided as a prefilled syringe, thus not requiring any reconstitution or conditioning prior to administration. Due to the superior ease of handling and administration, CAM2029 can be conveniently administered by the patients themselves. It is currently in phase III stage of development.
IONIS-GHR-LRx: Ionis Pharmaceuticals
IONIS-GHR-LRx is a Generation 2+ ligand-conjugated antisense (LICA) drug designed to reduce the production of the growth hormone receptor (GHr) to decrease the circulating level of insulin-like growth factor-1 (IGF-1). IGF-1 is a hormone primarily produced in the liver that plays an important role in childhood growth and has anabolic effects in adults. Several different diseases result from abnormally low or high levels of IGF-1, or an inappropriate response to this hormone. When produced in excess, IGF-1 results in acromegaly, a chronic, slowly progressing and life-threatening disease. It is currently in phase II stage of development.
Paltusotine: Crinetics Pharmaceuticals
Paltusotine establishes a new class of oral selective nonpeptide somatostatin receptor type 2, or sst2, biased agonists designed for the treatment of acromegaly. Somatostatin is a neuropeptide hormone that broadly inhibits the secretion of other hormones, including growth hormone, or GH, from the pituitary gland. Acromegaly arises from a benign pituitary tumor that secretes excess GH that in turn causes excess secretion of insulin-like growth factor-1, or IGF-1, by the liver. This loss of homeostasis in the GH axis results in excess tissue growth and other adverse metabolic effects throughout the body. It is in phase II stage of development.
Veldoreotide: Strongbridge Biopharma plc
Veldoreotide, or COR-005, is a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. In short-term Phase 1 and 2 studies in healthy volunteers and untreated patients with acromegaly, respectively, the effects of subcutaneously administered veldoreotide on stimulated or basal growth hormone and postprandial glucose and insulin secretion were compared with those of subcutaneous injections of immediate-release octreotide. The findings suggest that veldoreotide has similar ability as octreotide to suppress growth hormone but has reduced propensity to inhibit postprandial insulin.
Further product details are provided in the report..
Acromegaly: Therapeutic Assessment
This segment of the report provides insights about the different Acromegaly drugs segregated based on following parameters that define the scope of the report, such as:
Major Players in Acromegaly
There are approx. 40+ key companies which are developing the therapies for Acromegaly. The companies which have their Acromegaly drug candidates in the most advanced stage, i.e. phase III include Camurus AB and others
Phases
DelveInsights report covers around 40+ products under different phases of clinical development like
Late-stage products (Phase II and Phase II/III)
Mid-stage products (Phase II and Phase II/III)
Early-stage products (Phase I/II and Phase I) along with the details of
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates

Route of Administration
Acromegaly pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
Infusion
Intradermal
Intramuscular
Intranasal
Intravenous
Oral
Parenteral
Subcutaneous
Topical.
Molecule Type
Products have been categorized under various Molecule types such as
Gene therapies
Small molecule
Vaccines
Polymers
Peptides
Monoclonal antibodies

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

Acromegaly: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Acromegaly 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 Acromegaly drugs.

Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence Acromegaly R&D. The therapies under development are focused on novel approaches to treat/improve Acromegaly.
CAM2029 has been granted orphan designation by the European Commission for acromegaly.
In July 2020, Crinetics Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted paltusotine Orphan Drug Designation for the treatment of acromegaly.
Veldoreotide has been granted orphan drug designation by the FDA and the EMA.
Acromegaly Report Insights
Acromegaly Pipeline Analysis
Therapeutic Assessment
Unmet Needs
Impact of Drugs
Acromegaly 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 Acromegaly drugs?
How many Acromegaly drugs are developed by each company?
How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acromegaly?
What are the key collaborations (IndustryIndustry, IndustryAcademia), Mergers and acquisitions, licensing activities related to the Acromegaly 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 Acromegaly and their status?
What are the key designations that have been granted to the emerging drugs?
Key Players
Camurus AB
Ionis Pharmaceuticals
Crinetics Pharmaceuticals
Strongbridge Biopharma plc
Chiasma, Inc.
Ipsen
Endo Pharmaceuticals
Ambrilia Biopharma
Ono Pharmaceutical
Rani Therapeutics

Key Products
CAM2029
IONIS-GHR-LRx
Paltusotine
Veldoreotide
Octreotide capsules
BIM23B065
Octreotide
C2L-OCT-01
ONO-5788

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Introduction
Executive Summary
Acromegaly: Overview
Causes
Mechanism of Action
Table 1 Total Products for Acromegaly
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type

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