Introduction to CRN00808
CRN00808, also known as paltusotine hydrochloride, is a novel drug candidate under development by Crinetics Pharmaceuticals for the treatment of acromegaly and other conditions. Here’s a detailed look at its development progress and market projections.
Mechanism of Action
CRN00808 is a non-peptide, orally bioavailable somatostatin agonist that targets the somatostatin receptor type II (SSTR2). This mechanism is crucial for regulating the secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1), which are key factors in the pathophysiology of acromegaly[3][4].
Clinical Trials
Phase 2 Clinical Trials
Crinetics Pharmaceuticals has initiated two Phase 2 clinical trials for CRN00808: ACROBAT EVOLVE and ACROBAT EDGE.
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ACROBAT EVOLVE: This is a double-blind, placebo-controlled, randomized withdrawal study designed to evaluate the safety, pharmacokinetics, and efficacy of CRN00808 in adult patients with acromegaly who are responders to octreotide LAR or lanreotide depot. Patients will switch from their prior injectable therapy to CRN00808 capsules, taken once daily by mouth. The primary endpoint is the proportion of patients who meet responder criteria, defined as the mean of two consecutive IGF-1 measurements ≤ Upper Limit of Normal (ULN) after 13 weeks[1][4].
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ACROBAT EDGE: This is an open-label exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CRN00808 in patients with acromegaly who do not adequately respond to octreotide LAR or lanreotide depot monotherapy or require second-line therapies. Participants will switch to CRN00808 capsules for up to 13 weeks. The primary endpoint is the change from baseline in IGF-1 levels after 13 weeks[1][4].
Market Projections
Acromegaly Treatment Market Size
The global acromegaly treatment market is expected to experience significant growth in the coming years. As of 2022, the market size was valued at approximately USD 1.26 billion and is anticipated to expand at a compound annual growth rate (CAGR) of 5.7% from 2023 to 2030[5].
Growth Drivers
Several factors are driving the growth of the acromegaly treatment market:
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Increasing Prevalence of Acromegaly: The condition affects 40 to 125 persons per million people, and its increasing incidence is contributing to the high demand for advanced treatment options[2][5].
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Strong Drug Pipeline: CRN00808, along with other drugs like Somatuline Autogel by Ipsen Pharma and MYCAPSSA oral by Chiasma Inc., is expected to receive approval in the coming years, propelling market growth[2][5].
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Regional Expansion: North America currently holds the largest revenue share due to favorable governmental regulations and the increasing prevalence of acromegaly. However, the Asia Pacific region is projected to see the fastest CAGR due to rising healthcare spending and investments by pharmaceutical companies in countries like China and India[2][5].
Competitive Landscape
The acromegaly treatment market is consolidated and led by companies such as Ipsen Pharma, Novartis AG, and Pfizer Inc. New entrants and existing players are focusing on developing new formulations, partnerships, distribution agreements, and regional expansions to increase their revenue share. CRN00808, with its unique oral administration route and targeted mechanism, is poised to be a significant player in this market[5].
Innovation and Regulatory Considerations
CRN00808 has shown promising results in initial Phase 1 clinical trials, where once-daily administration resulted in IGF-1 lowering in healthy volunteers. The ongoing Phase 2 studies are critical for its regulatory approval and market entry. GlobalData’s proprietary machine learning models continuously update the likelihood of approval based on real-time events impacting the clinical development process and regulatory considerations[3][4].
Patient Enrollment and Study Centers
The ACROBAT studies are being conducted at specialized endocrinology centers around the world, including centers in Europe, the United Kingdom, and the United States. Patient enrollment is ongoing, and Crinetics Pharmaceuticals has launched a website to encourage patients to join these studies[4].
Key Takeaways
- CRN00808 is a non-peptide, orally bioavailable somatostatin agonist under development for acromegaly.
- Phase 2 Clinical Trials: ACROBAT EVOLVE and ACROBAT EDGE are evaluating the safety, pharmacokinetics, and efficacy of CRN00808.
- Market Growth: The acromegaly treatment market is expected to grow at a CAGR of 5.7% from 2023 to 2030.
- Regional Expansion: North America and the Asia Pacific region are key markets, with the latter expected to see the fastest growth.
- Competitive Landscape: CRN00808 is poised to be a significant player in a market dominated by Ipsen Pharma, Novartis AG, and Pfizer Inc.
FAQs
What is CRN00808 and how does it work?
CRN00808 is a non-peptide, orally bioavailable somatostatin agonist that targets the somatostatin receptor type II (SSTR2) to regulate the secretion of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).
What are the ongoing clinical trials for CRN00808?
The ongoing clinical trials include ACROBAT EVOLVE and ACROBAT EDGE, both Phase 2 studies evaluating the safety, pharmacokinetics, and efficacy of CRN00808 in patients with acromegaly.
What is the current market size and growth projection for the acromegaly treatment market?
The global acromegaly treatment market was valued at approximately USD 1.26 billion in 2022 and is expected to grow at a CAGR of 5.7% from 2023 to 2030.
Which regions are expected to see significant growth in the acromegaly treatment market?
North America currently holds the largest revenue share, but the Asia Pacific region is projected to see the fastest CAGR due to rising healthcare spending and investments by pharmaceutical companies.
Who are the key players in the acromegaly treatment market?
The market is led by companies such as Ipsen Pharma, Novartis AG, and Pfizer Inc., with new entrants like Crinetics Pharmaceuticals also making significant contributions.
What are the primary endpoints of the ACROBAT EVOLVE and ACROBAT EDGE studies?
For ACROBAT EVOLVE, the primary endpoint is the proportion of patients who meet responder criteria (mean of two consecutive IGF-1 measurements ≤ ULN after 13 weeks). For ACROBAT EDGE, the primary endpoint is the change from baseline in IGF-1 levels after 13 weeks.
Where are the ACROBAT studies being conducted?
The studies are being conducted at specialized endocrinology centers around the world, including centers in Europe, the United Kingdom, and the United States.
Sources
- Crinetics Pharmaceuticals Doses First Patients in Phase 2 Clinical Trials of CRN00808 for Acromegaly - Crinetics Pharmaceuticals.
- Acromegaly Treatment Market Size and Forecast to 2032 - SkyQuest.
- Paltusotine hydrochloride (CRN-00808) in Acromegaly - Likelihood of Approval and Phase Transition Success Rate Model - GlobalData.
- Developing a new drug for acromegaly - Pituitary World News.
- Acromegaly Treatment Market Size And Share Report, 2030 - Grand View Research.
Last updated: 2025-01-01
