Crinetics Pharmaceuticals Initiates Phase 1 Study of CRN01941 for the Treatment of Neuroendocrine Tumors


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 tumors, today announced the initiation of a Phase 1, double-blind, randomized, placebo-controlled, single and multiple-dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CRN01941 in healthy volunteers.

What is CRN01941?

It’s an oral nonpeptide somatostatin receptor subtype 2 (sst2) biased agonist* designed for the treatment of neuroendocrine tumors (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.  I’m guessing that the use of terms such as ‘non-peptide’ means that it may not be the same as a somatostatin analogue, but the method of operation appear 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.

This trial launch follows other products including a similar capsule based somatostatin receptor product for treating Acromegaly called CRN00808,  currently undergoing two Phase 2 clinical trials. 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.

On the basis that the CRN00808 Phase 2 trial for Acromegaly is using patients previously treated with somatostatin analog based treatment regimens, I suspect this drug is designed for the same market as Sandostatin LAR/Octreotide and Somatuline (Lanreotide).  For more information, please visit www.crinetics.com.

The Phase 1 Clinical Trial of CRN01941 for NETs

The trial is initially only based in Perth Western Australia, 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 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.

Thanks for reading

Ronny

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Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

Ronny Allan is an award winning patient leader and advocate for Neuroendocrine Cancer.


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Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

 

In my article listing the somatostatin analogues and their drug delivery systems pipeline (click here), there has been a very interesting development in a product called Q-Sphera (was previously known as Q-Octreotide).  In a press release, it was announced that an unnamed ‘pharma giant’ has signed a deal with Midatech Pharma Plc that will see it evaluate the latter’s Q-Sphera drug delivery platform.  Later in Feb 2019, the pharma was identified as China Medical System Holdings Limited (based out of Hong Kong).  Adding to the excitement behind this development, it was announced in Mar 2019 that the Spanish Government had conditionally approved a €6.6m loan that will be used to help commercialise this flagship drug.

Midatech’s Q-Sphera™ is an advanced microencapsulation and polymer-depot sustained release (SR) drug delivery platform produced using a novel and disruptive printing based process, with numerous and distinct advantages over conventional reactor based technologies. From a manufacturing perspective Q-Sphera™ is a precise, scalable, efficient, and environmentally friendly microparticle platform. From a clinical perspective Q-Sphera™ ensures monodispersed microparticles that release active drug compounds into the body in a superior linear tightly controlled and predictable manner over an extended period of time from 1 – 6 months.  An injection lasting 6 months sounds very exciting but I have no more detail on the feasibility or likelihood of such a change in frequency with Octreotide or Lanreotide but the press release does mention the possibility, i.e. “Q-Sphera allows drug compounds to be released into the body in a “highly controlled manner” over a prolonged period of time; potentially from a few days to up to six months.”

What’s the main differences?

The current trials are based on the use of Sandostatin LAR (Octreotide) using the Q-Sphera delivery system (previously known as Q-Octreotide). The key aspects of usability are reconstitution and needle size but there is also an inference that less frequent injections could be possible.   A comparison of the trial output is as follows:

  • Reconstitution: For Sandostatin LAR (SLAR)™ the procedure to prepare the product for injection is a complex 30 step error prone process, taking up to 40 minutes and, once reconstituted, the product has to be given immediately to prevent solidifying and wastage of the injection. For MTD201™ Q-Octreotide the preparation process is a simple 5 – 7 minute procedure, after which the product is stable up to 2 hours. For the nurse preparing and giving the injection, the short and flexible process of MTD201™ has clear advantages over the all consuming SLAR process™.
  • Needle size: For SLAR, a large 19G needle is prescribed for the injection to prevent blockage, and often an even large 18G needle is required for successful injection. For MTD201 Q-Octreotide the precision microencapsulation technology means that a much smaller 21G needle can be used, and there are no blockages. Other Q-Sphera products use even finer needles as small as 27G. The importance of this is evident from the first-in-human phase I data where MTD201 had lower injection pain – 8% for MTD201 versus 25% for SLAR™, and much lower injection site
    tenderness – 8% for MTD201 versus 83% for SLAR.

This is an exciting development and I will keep this article live with further information as I receive it.

Thanks for reading

Ronny

I’m also active on Facebook. Like my page for even more news. I’m also building up this site here: Ronny Allan

Disclaimer

My Diagnosis and Treatment History

Most Popular Posts

Sign up for my twitter newsletter

Read my Cure Magazine contributions

Remember ….. in the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life!

patients included

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