Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111) - Seite 2

Rani’s single-center, open label, Phase 1 study of RT-111 was conducted in Australia. The study evaluated the safety, tolerability, and pharmacokinetics (PK) of RT-111 in healthy adult volunteers. The study enrolled 20 participants each in RT-111 0.5mg and 0.75mg dose groups, and 15 participants in a STELARA (ustekinumab) 0.5mg subcutaneous (SC) injection group.

Phase 1 Topline Results

Pharmacokinetics

• Oral RT-111 delivered ustekinumab biosimilar in a dose proportional manner and with high bioavailability (estimated at 84% relative to subcutaneous injection).
• Oral RT-111 demonstrated a higher Cmax and shorter Tmax compared to ustekinumab delivered by SC injection (0.5mg).

	Stelara SC 0.50mg	RT-111 0.50mg	RT-111 0.75mg
Cmax (ng/mL)	56 ± 4	67 ± 7	92 ± 8
Tmax (days)	10 ± 0.8	3.1 ± 0.2*	3.3 ± 0.2*
AUC (day*ng/mL)	1,566 ± 130	1,315 ± 150	1,814 ± 165

Data are Mean ± SE from all subjects, including those with anti-drug antibodies. *p<0.0001 significantly different from SC group.

Safety and Tolerability

• RT-111 was well-tolerated by all participants in the two RT-111 groups, and no serious adverse events were observed in the study.
• There was no meaningful difference in incidence of anti-drug antibodies (ADA) via RaniPill route of delivery, compared to STELARA SC injection.
• No participants reported difficulty swallowing the capsule and capsule remnants passed from all participants without sequelae.
  

The ustekinumab biosimilar used in RT-111 is manufactured and supplied by Celltrion, Inc. (“Celltrion”) under Rani’s License and Supply Agreement with Celltrion announced in January 2023. Under that agreement, Celltrion exclusively supplies to Rani the ustekinumab biosimilar drug substance (CT-P43) required for RT-111. Rani is granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial that meets its primary endpoint(s).