Acromegaly - Pipeline Insight, 2020

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Date: 24-Sep-2020
No. of pages: 90
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DelveInsight's, "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

DelveInsight's 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 (Industry-Industry, Industry-Academia), 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

Acromegaly - Pipeline Insight, 2020

Table of Contents

Introduction
Executive Summary
Acromegaly: Overview
* Causes
* Mechanism of Action
* Signs and Symptoms
* Diagnosis
* Disease Management
Pipeline Therapeutics
* Comparative Analysis
Therapeutic Assessment
* Assessment by Product Type
* Assessment by Stage and Product Type
* Assessment by Route of Administration
* Assessment by Stage and Route of Administration
* Assessment by Molecule Type
* Assessment by Stage and Molecule Type
Acromegaly - DelveInsight's Analytical Perspective
In-depth Commercial Assessment
* Acromegaly companies' collaborations, Licensing, Acquisition -Deal Value Trends
Acromegaly Collaboration Deals
* Company-Company Collaborations (Licensing / Partnering) Analysis
* Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
* Comparative Analysis
CAM2029: Camurus AB
* Product Description
* Research and Development
* Product Development Activities
Mid Stage Products (Phase II)
* Comparative Analysis
IONIS-GHR-LRx: Ionis Pharmaceuticals
* Product Description
* Research and Development
* Product Development Activities
Paltusotine: Crinetics Pharmaceuticals
* Product Description
* Research and Development
* Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
* Comparative Analysis
Drug Name: Company Name
* Product Description
* Research and Development
* Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
* Comparative Analysis
Drug Name: Company Name
* Product Description
* Research and Development
* Product Development Activities
Inactive Products
* Comparative Analysis
Acromegaly Key Companies
Acromegaly Key Products
Acromegaly- Unmet Needs
Acromegaly- Market Drivers and Barriers
Acromegaly- Future Perspectives and Conclusion
Acromegaly Analyst Views
Acromegaly Key Companies
Appendix

List of Tables

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
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

List of Figures

Figure 1 Total Products for Acromegaly
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
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