Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

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Update as of 5th May 2022

One Phase 2 trial has now been entered in the Clinical Trials database, based at the University of Kentucky (Markey Cancer Center).  Read the clinical trial document by clicking here.  The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose-response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase

Update as of 12th January 2022.

Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that Scott Struthers, Ph.D., founder & CEO of Crinetics, will provide a company update at the 40th annual J.P. Morgan Healthcare Conference today, Wednesday, January 12th at 4:30 PM Eastern Time / 1:30 PM Pacific Time. A live audio webcast of Dr. Struthers’ presentation may be accessed on the Events page of the company’s website.

During his presentation, Dr. Struthers will discuss Crinetics’ key priorities and anticipated milestones for 2022. These include:

  • Continued progress in the two ongoing Phase 3 PATHFNDR trials of paltusotine in acromegaly. Both trials remain on track and topline data is expected in 2023.
  • The initiation of patient dosing in a Phase 2 trial of paltusotine in patients with carcinoid syndrome associated with neuroendocrine tumors (NETs), which is expected in 2022.
  • Reporting Phase 1 multiple ascending dose (MAD) data for CRN04894, an investigational, oral, nonpeptide adrenocorticotropic hormone (ACTH) antagonist being developed for the treatment of Cushing’s disease and congenital adrenal hyperplasia, which is expected in 1Q 2022.
  • The initiation of a Phase 2 trial of CRN04894, which is expected in 2H 2022.
  • Reporting Phase 1 MAD data for CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist being developed for the treatment of congenital hyperinsulinism, which is expected in 1Q 2022.
  • The initiation of a Phase 2 trial of CRN04777, which is expected in 2H 2022.
  • The initiation of IND-enabling studies for a parathyroid receptor type-1 (PTHR1) antagonist, which is expected in 2022. Target indications for this program potentially include hyperparathyroidism and humoral hypercalcemia of malignancy.

Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumours.  They have a lead molecule, paltusotine (also referred to as CRN01941 for NET and more recently as CRN00808 for Acromegaly and NET), that may turn out to be best in class. Phase 2 testing for Acromegaly is on track to be completed in Q4 2020. Phase 3 trial likely in 2021 and if successful, they are hoping for FDA approval in 2023 (although the impact of COVID may move these dates to the right).  But it is already behind as FDA recently approved Chiasma’s Mycapssa product earlier this year.  This article indicated paltusotine may be a superior product. 

The company is also developing oral nonpeptide somatostatin agonists for hyperinsulinism, as well as oral nonpeptide ACTH antagonists for the treatment of Cushing’s disease and an SST5 antagonist for hyperinsulinism.

What is Paltusotine

It’s an oral nonpeptide somatostatin receptor subtype 2 (sst2) biased agonist* designed for the treatment of neuroendocrine tumours (NETs) that originate from neuroendocrine cells commonly found in the gut, lung, or pancreas.  From the detail contained in the clinical trials document (see below), it appears to involve a capsule.  The method of operation appears to be similar in that it wants to bind to somatostatin receptor 2 (SST2).   I will bring more technical detail once I have it.  * chemical that binds to a receptor and activates the receptor to produce a biological response.  In the meantime, see short video and note that the drug for Acromegaly is more advanced in pipeline terms.  

Paltusotine for Neuroendocrine Tumors (NETs)

In terms of the effect on NETs, these tumours typically over express SST2, somatostatin type 2 receptors. Both SST2 and 3 are involved in apoptosis of neuroendocrine tumour cells.” Paltusotine’s high level of selectivity for the SST2 receptor may translate into better efficacy in the treatment of neuroendocrine tumours given the role of the SST2 receptor. In fact, Crinetics describes paltusotine as an “oral selective SST2 agonist” differentiating it from existing molecules lacking this selectivity. Clinical trials scheduled to begin in early 2021 will determine whether this selectivity translates to improved efficacy in the treatment of neuroendocrine tumours.

For more information, please visit http://www.crinetics.com

The Phase 1 Clinical Trial of Paltusotine (formerly CRN01941) for NETs

The trial is initially only based in Perth Western Australia with a target of around 120 participants. It is not yet known if there are any plans to expand locations in subsequent phases or parts of the trial.  It also appears they are trialling the use of a capsule-based drug and another delivery method as yet unknown; the clinical trial only mentions “Oral Solution”, so it isn’t an injection. Read more at ClinicalTrials.gov using the identifier NCT03936166.  This trial is now complete. 

This is not the first somatostatin receptor-based product in the pipeline, please also check out my article about Somatostatin Analogues and Delivery Mechanisms in the pipeline – click here.

Summary of sources:

1.  Press Release – click here.
2. Manufacturers Website – click here.
3. Clinical Trials Document – click here.

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. 

Inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 

 
 

Whenever I post about a new trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

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5 thoughts on “Clinical Trial of Paltusotine for the Treatment of Neuroendocrine Tumours

    • It looks like it but very early days. There are other more advanced capsule replacements in the pipeline, see the article linked at the end of this one.

      • Deanna

        A very uplifting report Ronny, thankyou. Maybe not too far away we can just travel with our capsules instead of staying within (for me) 3-week reach of nurse-with-injection……

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