Tim McCarthy, Chief Executive Officer of ImmuPharma PLC talks to Zak Mir

Zak Mir talks to Tim McCarthy, CEO of Immupharma, the speciality biopharmaceutical company that discovers and develops peptide-based therapeutics, announcing the filing of a groundbreaking new patent application for its lead asset, P140, the world’s first “Immunormalizer.”

The three discoveries that reset the strategy

• Under-dosing: The team concluded the dose used in the Phase III trial was far too low — roughly 10 to 15 times lower than the dose they now believe is required to achieve the intended biological effect.
• Steroid confounding: Standard-of-care steroids given to patients in the trial suppress the immune system and masked P140’s effect. Future trials will include steroid tapering protocols so the drug’s impact isn’t obscured.
• Patient stratification — “super responders”: For the first time the team identified a patient profile that responds exceptionally well to P140. That diagnostic signature is central to the patent and allows the drug to be matched to the right patients.

What P140 actually does — the Immunormalizer concept

Tim described P140 as an agent that restores immune homeostasis rather than suppressing the immune system. That’s an important distinction:

• Most current therapies try to blunt or suppress immune activity (e.g., steroids or many immunomodulators), which can cause side effects and still leave patients vulnerable.
• P140 appears to "normalize" the immune response — increasing or decreasing components such as B cells toward a healthy balance depending on what the patient needs.
• In practice that means if a patient has excessive B-cell activity, P140 reduces it; if a patient has deficient activity, P140 can boost it — a balancing action not commonly seen in current treatments.

"“We’ve coined the phrase ‘Immunormalizer’ — it brings the immune system back to normal homeostasis rather than simply suppressing it.”"

Safety profile that matters

Across preclinical studies, Phase I/II and the Phase III programme, P140 demonstrated an unusually clean safety record: no serious adverse events and very few side effects. Tim highlighted this as a major reason the team pursued the diagnostic-plus-therapeutic patent: a safe mechanism that can be targeted precisely.

The diagnostic: identifying “Type M” immune disorder patients and super responders

One of the most exciting elements of the patent is the combination of a diagnostic test with the therapeutic. The diagnostic identifies patients with what ImmuPharma calls a “Type M” immune disorder — those who are likely to be super responders to P140.

• This stratification means future clinical trials will enroll patients who have the biomarker profile most likely to benefit, improving the chance of clear, positive outcomes.
• The diagnostic is precise enough that it could identify at-risk patients even before symptoms appear, enabling earlier intervention.
• Tim suggested it could potentially be incorporated into routine health checks, allowing doctors to pick up vulnerability to autoimmune disease much earlier than current practice permits.

"“We can identify those patients that are responding to P140 and identify them as the Type M patients before they’re even getting the disease.”"

Clinical path forward: higher doses, steroid tapering, targeted enrolment

Building on the three discoveries, the next clinical plan is straightforward:

1. Use higher dosing (10–15× what was used previously) to reach therapeutic exposure.
2. Incorporate steroid tapering in trial protocols to avoid immune suppression masking the drug’s effect.
3. Enroll biomarker-positive “Type M” patients (super responders) to maximise the chance of demonstrating efficacy.

These changes address the confounders that affected the earlier trial and are supported by additional preclinical work that underpinned the patent filing.

From lupus to a broad autoimmune opportunity

Although P140’s clinical history has focused on lupus, Tim explained the mechanism is broadly applicable across autoimmune diseases — there are around 50 recognised autoimmune conditions. The key is that within each disease there are subsets of patients who match the Type M profile and may respond to P140.

That opens a large commercial and clinical opportunity: diagnose earlier, treat the right patients, and potentially prevent disease development. Tim compared the potential impact to other recent transformative therapies in adjacent areas — stressing that the market opportunity and patient benefit could be enormous.

Commercial strategy: partners, patents and deals

ImmuPharma’s plan is to partner with larger pharma companies for develo