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Research: Healthcare
Sareum has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has turned down the clinical trial authorisation (CTA) for SDC-1801 based on the submitted data package. While Sareum awaits the formal letter of non-acceptance, initial insights suggest that the MHRA will seek a review by the UK Good Laboratory Practice Monitoring Authority or request additional information to support the submitted non-clinical data. As a reminder, Sareum filed the CTA for SDC-1801 in July 2022 with the intention of commencing the Phase Ia trial in Q4 CY22. While the company is seeking further clarification from the MHRA on the requirements for resubmission, we now anticipate a delay in launching clinical activity.
Sareum Holdings |
SDC-1801 CTA application hits a roadblock
Pharma and biotech |
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9 November 2022 |
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Sareum Holdings is a research client of Edison Investment Research Limited |
Sareum has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has turned down the clinical trial authorisation (CTA) for SDC-1801 based on the submitted data package. While Sareum awaits the formal letter of non-acceptance, initial insights suggest that the MHRA will seek a review by the UK Good Laboratory Practice Monitoring Authority or request additional information to support the submitted non-clinical data. As a reminder, Sareum filed the CTA for SDC-1801 in July 2022 with the intention of commencing the Phase Ia trial in Q4 CY22. While the company is seeking further clarification from the MHRA on the requirements for resubmission, we now anticipate a delay in launching clinical activity.
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Source: Company data. Note: *EPS figures have been adjusted retrospectively for the 50:1 share consolidation in March 2022. |
SDC-1801, a novel TYK2/JAK1 inhibitor, is Sareum’s lead asset, targeting autoimmune indications such as psoriasis, lupus and inflammatory bowel disease. The drug has been engineered to selectively target the TYK2/JAK1 enzymes, with the aim of circumventing the safety and toxicity issues related to the JAK2 and JAK3 isoforms and thereby offering a safer alternative to the currently approved JAK inhibitors. SDC-1801 completed a preclinical toxicology studies in Q421 and the CTA was filed in July 2022. Sareum has developed a capsule formulation of the drug with the synthesis of the drug’s active pharmaceutical ingredient, under good manufacturing practice conditions. We highlight that the company does not undertake any R&D activities internally and that all development work is outsourced to specialist contract research organisations (CROs).
The decision by the MHRA is unexpected as Sareum maintains that the preclinical data package it submitted was robust and collated in collaboration with highly specialised CROs. The magnitude of the issue and what exactly the MHRA observations relate to is unclear. Sareum is in talks with the MHRA to seek further information and will be updating the market on subsequent developments. The company had planned to initiate the Phase Ia trial (safety and dose-finding study in healthy volunteers) in Q422 which, in our opinion, is now likely to be delayed until 2023 at the earliest.
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Research: Healthcare
IRLAB Therapeutics has reported Q322 results, providing an operational and financial update that are largely in line with our estimates. Patient recruitment for the critical Phase IIb mesdopetam trial in Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs) concluded in September 2022. We view this as a positive indicator for the company being on track to deliver top-line readouts by around the end of FY22. The Q322 net loss of SEK23.9m, in line with previous quarters, brought the net loss for the first nine months of FY22 (9M22) to SEK80.2m. At end-Q322, IRLAB had net cash of SEK291.7m which, at the current quarterly burn rate (Q322: SEK30.1m), we expect will fund operations well into FY24. We value IRLAB at SEK6.72bn or SEK129.8/share (previously SEK6.40bn or SEK123.7/share).
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