RAPT Therapeutics (RAPT) Leerink’s Global Healthcare Conference 2025 summary

Strategic focus and recent developments

• Licensed RPT-904, a half-life extended omalizumab biobetter, targeting food allergy and chronic spontaneous urticaria (CSU) as initial indications.

• Jemincare, the partner in China, is advancing RPT-904 in asthma and CSU, with phase II data expected in the second half of the year.

• Food allergy market seen as a major opportunity, with over 40,000 patients on Xolair and a projected $40 billion market size.

• RPT-904 offers half-life extension and improved pharmacodynamics over omalizumab, with a twofold increase in half-life and deeper IgE reduction.

• Market research indicates strong prescriber and payer interest in less frequent dosing (Q8 or Q12 weeks).

Clinical development plans and trial design

• Phase IIB food allergy study to start at year-end, modeled after the OutMatch phase III study, with top-line data expected in the first half of 2027.

• Study will initially enroll adolescents and adults, expanding to children as safety data accrues.

• Two dosing arms (Q8 and Q12 weeks) will be tested versus placebo, aiming for greater convenience than current Xolair regimens.

• Dose selection based on PK modeling and phase I data, with Q12 week dosing expected to cover most patients, including some currently excluded from Xolair labeling.

• Approximately 30% of food allergy patients are excluded from current dosing tables, representing a significant unmet need.

Market positioning and commercial insights

• Payers and prescribers value less frequent dosing for improved compliance and outcomes, potentially justifying a premium price.

• Biosimilar competition is anticipated, with expected price erosion of 30-40% versus branded omalizumab.

• Awareness of biologic options for food allergy remains low, suggesting significant market expansion potential.

• Long-acting formulations could attract patients averse to frequent injections and expand the addressable market.