Rani Therapeutics

Rani Therapeutics is a clinical-stage biotherapeutics company focused on developing orally administered biologics and drugs. The company's core technology is the RaniPill capsule, a novel oral delivery platform designed to replace subcutaneous injections or intravenous infusions of biologics and drugs. The RaniPill capsule is a robotic pill that moves intact through the stomach and delivers drugs via painless injection in the intestine, where they are rapidly absorbed. Rani has developed two versions of the RaniPill: the RaniPill GO, which can deliver payloads up to 3mg, and the RaniPill HC, a high-capacity version capable of delivering payloads up to 20mg.

Rani's pipeline includes several product candidates utilizing the RaniPill technology. The company had successfully completed three Phase 1 clinical trials. One of these was for RT-111, an oral formulation of ustekinumab (a biosimilar to Stelara) for autoimmune conditions. In the Phase 1 trial, RT-111 demonstrated high bioavailability (estimated at 84% relative to subcutaneous injection) and was well-tolerated with no serious adverse events. Rani is also developing RT-102, an oral parathyroid hormone for osteoporosis, which showed 300-400% greater bioavailability than subcutaneous injection in early trials.

The company believes its technology could potentially enable the oral delivery of most biologics currently on the market, offering patients a more convenient alternative to injections. Rani's approach is drug-agnostic, allowing for the delivery of various types of molecules including peptides, proteins, and antibodies. The company is advancing an internal pipeline while also seeking partnerships to maximize the value of its RaniPill technology.

Key customers and partnerships

Rani Therapeutics has established a partnership with Celltrion, Inc., announced in January 2023. Under this agreement, Celltrion exclusively supplies Rani with the ustekinumab biosimilar drug substance (CT-P43) required for RT-111. Celltrion also has the right of first negotiation to acquire worldwide rights to RT-111 following a successful Phase 1 clinical trial.