Inhibikase Therapeutics (IKT) Maxim Group’s 2024 Healthcare Virtual Summit summary

Strategic overview and recent developments

• Raised significant capital to advance programs in pulmonary arterial hypertension (PAH) and Parkinson’s disease, attracting major biotech investors.

• Focused on two late-stage clinical assets: Risvodetinib (brain-penetrant c-Abl inhibitor for Parkinson’s) and IKT-001 Pro (prodrug of imatinib for PAH).

• PAH program gained momentum after positive investor response and recent setbacks in competing therapies.

• FDA recognized IKT-001 Pro as a new molecular entity, opening commercial and regulatory opportunities.

• Board expanded with high-profile industry leaders following the capital raise.

Clinical and scientific insights

• Risvodetinib demonstrated neuroprotective and disease-modifying effects in preclinical and early clinical studies, targeting alpha-synuclein pathology in Parkinson’s.

• IKT-001 Pro designed to mitigate side effects of imatinib, with preclinical and healthy volunteer studies showing improved tolerability.

• Upcoming phase 2b PAH trial will use pulmonary vascular resistance as a primary endpoint, with first patient dosing expected next summer.

• 201 trial in Parkinson’s to be unblinded within weeks, with results expected to inform next-stage development.

• Combination therapy with sotatercept and IKT-001 Pro may offer synergistic benefits for PAH patients.

Regulatory and operational plans

• Pre-IND meeting with FDA confirmed eligibility for 505(b)(2) pathway and potential for breakthrough designation for IKT-001 Pro.

• Intellectual property protection extends to at least 2044, with multiple layers of composition and use patents.

• Phase 2b PAH trial to enroll 150 patients across 60 global centers, with interim safety and fertility analyses planned.

• Capital raised is expected to fund the PAH trial through completion and support intermediate steps for Parkinson’s program.

• Key hires and operational build-out underway to support both programs.