RE: CTA10 Nov 2022 21:24
Preclinical development activities required to apply for the CTA have been successfully concluded and, consistent with the Company's clinical development plan, an application for a CTA has now been filed.
Sareum, working alongside a specialist contract research organisation (CRO), has designed a Phase 1a/b clinical trial with SDC-1801 in healthy subjects and psoriasis patients.
Whilst the Company has yet to receive a formal letter of non-acceptance, the MHRA has indicated that it seeks a review by the UK Good Laboratory Practice (GLP) Monitoring Authority, or further support, of the non-clinical data submitted as part of the application to approve the clinical study.
'Extract
Non-clinical data
Non-clinical data is research data generated from in vitro laboratory studies and from in vivo studies in animals. The data help characterize the important pharmacokinetic (what the body does to the drug) and pharmacodynamic (what the drug does to the body) features of a medicinal product. Non-clinical data is also used to help predict the expected toxicity profile and this is of paramount importance for first-in-man studies. In such cases, assessment of non-clinical data influences the decision to proceed with a clinical trial.
Clinical data often supersedes non-clinical data during the later stages of the development programme of a new medicinal product. However, some characteristics of a medicinal product cannot be ethically researched in humans (reproductive toxicity, carcinogenic potential, and genotoxicity).
For regulatory submissions, a detailed non-clinical overview must be included in Module 2 of the dossier.
The overview will include reference to GLP compliance and detailed description of the experimental systems, results, and overall conclusions.
Make out what you like from the above.
My take on it is Sareum will have the information contained in detail in in vivo and in vitro preclinical. But exists in pages and pages of data that they have supplied.
Some of you may remember a post with regards to this. In a nutshell they (MHRA) are not going to spend hours looking through reams of paperwork to extract information whilst a separate overview is all that is required. At the same time you cannot omit the attention to detail in your investigational /study data.
However, what I believe to be required is an overview of the correct corresponding procedures relating to these preclinical studies. Sareum will need submit an overview to provide further details of GLP compliance. This i believe would be a prerequisite prior to reviewing preclinical results.
Establish the means and controls that are in place during the periods these investigations and studies are carried out to ensure compliance with GLP.
May take several days to resolve if not longer. In the meantime, do not be surprised if the SP slides further. But it is nothing that cannot be resolved.
Regards
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