AlzeCure Pharma (ALZCUR) Study Update summary

Unmet medical need and pain epidemiology

• Chronic pain affects a significant portion of the population, with neuropathic pain impacting 7-8% and only 20% of patients satisfied with current treatments.

• Chronic pain is associated with high societal costs, comorbidities, and reduced quality of life, often comparable to depression or heart disease.

• Current pharmacological treatments for neuropathic pain have limited efficacy, significant side effects, and a high discontinuation rate.

• There is a strong need for more effective, predictable, and safer pain treatments, especially those with local action and minimal systemic exposure.

ACD440: Mechanism, formulation, and clinical rationale

• ACD440 is a topical TRPV1 antagonist gel targeting neuropathic pain with thermal hypersensitivity, offering low systemic exposure and ease of use.

• The gel formulation is fast-drying, non-sticky, and suitable for self-administration, with a long shelf life and patent protection.

• TRPV1 receptors are upregulated in affected skin areas in neuropathic pain, making them a validated target for local treatment.

• The approach allows for phenotypic selection of patients likely to respond, improving predictability and reducing trial-and-error in treatment.

Clinical results and competitive landscape

• Phase Ib in healthy volunteers showed significant analgesic effect and long duration of action, with a strong safety profile and minimal systemic exposure.

• Phase IIa in patients with peripheral neuropathic pain and thermal hyperalgesia demonstrated a clinically meaningful reduction in pain, especially in those with TRPV1-positive phenotypes.

• ACD440 can be combined with other analgesics without risk of drug interactions or abuse, and showed efficacy as an add-on therapy.

• The topical TRPV1 antagonist approach is clinically validated, as seen with Novartis' SAF312, which achieved significant deal value after positive clinical results.