Rani Therapeutics Reports Positive Phase 1 Results for Oral Anti-IL 12/23 Antibody (RT-111)

Feb. 05, 2024 – Rani Therapeutics Holdings, Inc. reported encouraging topline results from its Phase 1 clinical trial of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar (CT-P43). RT-111 was well-tolerated, with no serious adverse events, and achieved high bioavailability.

Key Highlights:

RT-111 delivered ustekinumab in a dose-proportional manner with an estimated 84% bioavailability relative to subcutaneous injection.
The study demonstrated higher peak concentration (Cmax) and shorter time to reach peak concentration (Tmax) compared to subcutaneous administration.
RT-111 was well-tolerated with no serious adverse events. Participants did not report difficulty swallowing the capsule, and capsule remnants passed without issues.
The Phase 1 study, conducted in Australia, included 20 participants each in the RT-111 0.5mg and 0.75mg dose groups, and 15 participants in a 0.5mg subcutaneous ustekinumab injection group. The results confirmed the clinical potential of RT-111 as an oral alternative to injectable biologics for patients with autoimmune conditions, offering a less burdensome dosing regimen.

Rani Therapeutics has now successfully completed three Phase 1 trials using its RaniPill® technology, marking significant progress towards developing oral biologics.

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