ImmuPharma plc        

Chairman's Statement

The first part of 2023 was a period of further progress for ImmuPharma, as we continued to focus on progressing our late-stage pipeline assets specifically, within our P140 autoimmune platform.

Most recently in June, the Company announced that, after receiving comprehensive guidance from the Food and Drug Administration ("FDA") on the new Phase 2/3 adaptive clinical trial protocol for the lead programme for the treatment of patients with systemic lupus erythematosus ("SLE/Lupus"), it is moving forward with the study, together with its US partner Avion Pharmaceuticals ("Avion").

Positive progress was also announced in May for a second high medical need disease, chronic idiopathic demyelinating polyneuropathy ("CIDP"). The Company received positive feedback from the FDA at a pre-IND meeting for a late-stage Phase 2/3 adaptive clinical program in patients, which is a further debilitating auto-immune condition within the Company's P140 platform.

In parallel with advancements in the late-stage clinical developments, the Company is also actively in discussions with a number of potential commercial partners for programmes across the Company's development portfolio.

Lupuzor™/P140 - opportunity and next steps

There are an estimated five million people suffering from Lupus, with approximately 5 million patients in the US, Europe and Japan (Source: Lupus Foundation of America). The prevalence in China may be 2-3 times that seen in the US. Current 'standard of care' treatments, including steroids and immunosuppressants, can potentially have either serious side effects for patients or limited efficacy, with over 60 per cent of patients not adequately treated.

ImmuPharma believes Lupuzor™/P140 has the potential to be a novel specific drug therapy for the treatment of Lupus by specifically modulating the immune system and halting disease progression in most Lupus patients. It has a unique mechanism of action and is not an immunosuppressant like other drugs. Lupuzor™/P140 normalises the over-activity of T-cells which are involved in the immune response leading to Lupus disease. Lupuzor™ taken over the long term may have the potential to prevent the progression of Lupus rather than just treating its symptoms, with the rest of the immune system retaining the ability to work normally.

A new major opportunity for P140 is CIDP, a rare acquired autoimmune disorder of peripheral nerves. It is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. CIDP is a potential orphan drug indication which would provide patent life extension of 7 years post-approval. 

The Board is confident that there is a route to market for P140 in Lupus and CIDP including further corporate collaborations.

Lupuzor™ Phase 2/3 Adaptive Study

As announced in June 2023, following the receipt of comprehensive guidance from the FDA, in conjunction with our US partner Avion, a Phase 2/3 adaptive clinical trial of P140 (Lupuzor™) in patients with Lupus will commence in H2 2023.

The trial design and protocol is substantially different from previous clinical trials that ImmuPharma has completed and includes maintaining subcutaneous dosing but at much higher concentrations and significant changes to patient inclusion criteria and primary and secondary clinical endpoints.

The detailed protocol and key elements of the clinical trial design will be communicated at a later stage 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).

Lupus ABC Consortium

The FDA's Center for Drug Evaluation and Research ("CDER") has partnered with the Lupus Research Alliance ("LRA") to launch the Lupus Accelerating Breakthroughs Consortium ("Lupus ABC"), a first-of-its-kind public-private partnership focused on addressing challenges impacting Lupus clinical trial success. 

Lupus ABC will convene people living with Lupus, medical societies, industry, academic clinical researchers and scientists, FDA, and other federal agencies to address scientific hurdles that are beyond the capacity of any single entity. By connecting those with lived experience with all parties involved in Lupus treatment research, CDER hopes to advance the development of urgently needed treatments for Lupus. 

This can only be extremely good news for Lupus patients worldwide, including ImmuPharma, our partners and our peers, in bringing new safe Lupus drugs to the market, sooner rather than later.

CIDP / P140

For P140 in CIDP we announced in April 2023 that we had received confirmation from the FDA for a pre- Investigational New Drug ("PIND") meeting date of 16 May 2023, to consider a Phase 2/3 adaptive trial study protocol.

In May 2023, ImmuPharma received positive guidance from FDA following the PIND meeting that confirms the route for a Phase 2/3 adaptive clinical study of P140 in CIDP.

The FDA feedback recognises that P140 is suitable to be studied in another disease indication in addition to SLE and this strongly supports the underlying science and mechanism of action of P140 across several auto-immune/inflammatory diseases and is a significant breakthrough for the P140 platform.

The Phase 2/3 adaptive clinical trial will be the first pivotal stage study of P140 in patients with CIDP: a rare neurological disease with high medical need.

An IND application is now being prepared for submission to the FDA, incorporating all guidance points. An application for Orphan Drug status for CIDP will be also submitted in parallel to the full IND application.

The CIDP market is expected to reach global sales of US$2.7bn by 2029.