LONDON (ShareCast) - (Sharecast News) - Autoimmune and cancer-focussed biotechnology company Sareum said in an update on Friday that it remained "confident" despite some recent setbacks.
The AIM-traded firm, which was holding its annual general meeting, said its potential autoimmune therapy SDC-1801 focussed on psoriasis, did not have its clinical trial authorisation approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

Chairman Dr Stephen Parker said the company provided a "robust" preclinical data package to support the clinical trial application, in collaboration with several "world-leading, internationally-recognised" contract research organisations.

"The MHRA has indicated that it requires an additional review by the UK Good Laboratory Practice (GLP) Monitoring Authority of part of the pre-clinical data included in the application to approve the clinical study," Dr Parker told shareholders.

"Sareum and its advisers have sought additional clarification from the MHRA and UK GLP on the next steps.

"In parallel with seeking clarification with the MHRA, the company is also assessing regulatory opportunities in other countries."

Sareum said it remained "committed" to SDC-1801, and was focussed on finding the "quickest and clearest pathway" to obtaining authorisation to commence clinical studies for the asset.

Its cancer immunotherapy SDC-1802, meanwhile, was still undergoing translational studies needed to define the optimal cancer application before completing toxicology and manufacturing studies.

Dr Parker said planning for those studies would incorporate what the company had learned from its experience with SDC-1801.

Finally, on its licensed selective Chk1 inhibitor SRA737, Sareum noted that GSK subsidiary Sierra Oncology told it in October that it intended to return the rights to Sareum's co-development partner, the CRT Pioneer Fund.

The firm said the SRA737 licence agreement had a 90-day notice period for termination, and so it expected the rights to be formally returned in January.

Sareum said it was evaluating the potential development opportunities for the asset with CRT.

"In conclusion, the board believes Sareum has a strong pipeline of kinase inhibitors which have the potential to provide great benefit to patients," Dr Parke said.

"The company is committed to advancing SDC-1801 into clinical development and is focused on finding the quickest and clearest pathway to obtaining authorisation to commence clinical studies for the asset, whether it be in the UK via the MHRA or other countries.

"The company also remains confident in the potential for SRA737 and now has the opportunity to be more closely involved in planning its future development."

At 1628 GMT, shares in Sareum Holdings were up 3.57% at 72.5p.

Reporting by Josh White for Sharecast.com.

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