ImmuPharma PLC announced key updates on its late stage P140 (Lupuzortm) program, in patients with systemic lupus erythematosus ("SLE/Lupus"). The design of the pivotal Phase 3 study includes a dose-range. This design is faster to complete than a Phase 2/3 adaptive study, while at the same time incorporating all the key objectives.

The company confidently expect the efficacious dose to be within this dose-range and The company expects no adverse events that could lead to product label warnings seen with all other approved drugs and standard of care, which are all immunosuppressants. The study design allows two interim analyses, so there will be short term updates on clinical activity of the drug. P140 is not an immunosuppressant, so a key objective will be to taper the use of steroids which are currently standard of care.

This distinction sets the stage for a new gold standard therapy, conveniently self-administered by the patient, once a month, which is safe and well tolerated unlike standard of care or any other molecule in development which are all immunosuppressedants with significant safety warnings. Further details on the protocol and key elements of the clinical trial design will be communicated, once the details of the trial are available on clinicaltrials.gov (a comprehensive database of privately and publicly funded clinical studies conducted around the world). The international Phase 3 dose-ranging study design and protocol is substantially different from previous clinical trials completed by ImmuPharma.

Dosing will still be a subcutaneous injection, once a month, but with significantly higher doses, which have demonstrated safety and tolerability as part of the clinical program. Two planned interim analyses during the course of the study will allow early indications of the effectiveness of P140. Recent further insights into P140's mechanism of action supports its position as the only non-immunosuppressing molecule in clinical development in the industry.

A new potential standard of care for SLE sufferers. As the study continues to move forward in 2024, further details on the study's timings, protocol and key elements of theclinical trial design will be communicated at regular intervals. Simbec-Orion, is an experienced, full-service Contract Research Organisation, with offices across UK, Europe, and the United States, specialising in Rare & Orphan conditions.

Simbec-Orion has previous direct experience in Lupus trials including conducting ImmuPharma's last Phase 3 study completed in 2018 and more recently conducted ImmuPharma's Pharmacokinetics (" PK") study completed in 2022. The whole P140 program was re-examined in 2021, and the Board decided that it required a completely different approach, not only to commence a new Phase 3 study in Lupus, but also to be clear on the product offering and target product profile. The three pillars of strength and confidence in new program are dose, design and MOA.

Dose After three FDA guidance meetings, further human and animal pharmacokinetics studies and reconciliation with efficacy demonstrated in the animal models, it was concluded that the previous dose used in clinical studies was too low. The new Phase 3 study will include dose-ranging up to 15 times higher than the original study dose of 200 micrograms. Design The design of the pivotal Phase3 study includes a dose- range. This design is faster to completed than a Phase 2/3 Adapted study, while at the sametime incorporating all the key objectives.