San Jose, California-based Rani Therapeutics, which is focused on the oral delivery of biologics and drugs, is partnering with Celltrion for the development of T-111, an orally administered ustekinumab biosimilar targeted at psoriatic arthritis, ulcerative colitis, Crohn’s disease, and psoriasis.
Under a license and supply agreement, the Korean firm will exclusively supply the ustekinumab biosimilar drug substance (CT-P43), required for RT-111, to Rani. In addition, the US innovator is granted an exclusive license to use CT-P43 in the development and commercialization of RT-111, while Celltrion has the right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial.
Rani has developed an oral delivery technology known as the RaniPill capsule, which is intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing. The RaniPill capsule is designed to administer biologics and drugs with bioavailability comparable to subcutaneous injection.
In October last year, the company announced it had started preclinical development of RT-111.
Ustekinumab, approved in the US as STELARA, is used for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn’s disease, and moderate to severe ulcerative colitis, all of which have large unmet medical needs for oral treatment.
“Ustekinumab has helped thousands of patients with inflammatory autoimmune diseases, but today the treatment requires regular long-term injections. Rani is developing RT-111, an orally administered ustekinumab biosimilar, with the goal of reducing the burden of treatment and improving outcomes for patients," said the developer.
FDA feedback on osteoporosis drug pathway
Last week saw the company announce that it had held a pre-IND meeting with the US Food and Drug Administration (FDA), following which, Rani said it now believes that a 505(b)(2) pathway is suitable for the development of RT-102 in the US.
The 505 (b)(2) pathway provides manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that's required with an NDA.
Rani said that it also obtained guidance from the FDA on its preclinical and clinical development plans for RT-102, the RaniPill GO containing a formulation of human parathyroid hormone (1-34) analog (PTH) for the potential treatment of osteoporosis.
In December last year, the company announced positive topline results from Part 2 of the Phase 1 study of that osteoporosis targeting capsule. The study achieved its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill GO.
“As we enter 2023, Rani has multiple upcoming clinical milestones that we believe could be transformative for the company, including the initiation of a Phase 2 trial for RT-102 - our first Phase 2 trial - and the initiation of three additional Phase 1 studies, including two antibody programs,” said Talat Imran, CEO of Rani.