Rani Therapeutics launches RT-111 development program

Robotic pill company Rani Therapeutics (Nasdaq:RANI) has begun developing RT-111, a RaniPill GO capsule containing a biosimilar of Johnson & Johnson’s (NYSE:JNJ) Stelara (ustekinumab).

The company anticipates that RT-111 could potentially treat psoriatic arthritis, ulcerative colitis, Crohn’s disease and psoriasis.

The FDA first approved Stelara in 2009 for psoriasis.

Stelara is available in intravenous and subcutaneous doses. It is most commonly administered subcutaneously.

“Ustekinumab has helped thousands of patients with inflammatory autoimmune diseases, but today the treatment requires regular long-term injections,” said Talat Imran, Rani CEO, in a news release.

The company hopes that RT-111 will reduce the treatment burden for ustekinumab candidates.

“We are increasingly excited about the potential of the RaniPill platform to provide patients with oral replacements to current injectable standards of care, and we expect that RT-111 will be the first of many expansions of our pipeline,” Imran said.

Rani Therapeutics also has a Phase 1 study underway for RT-102 for RT-102, a RaniPill Go with a human parathyroid hormone–based candidate for osteoporosis.

The company intends to launch a Phase 2 study of RT-102 in 2023.

Rani Therapeutics is also developing RT-101, its original RaniPill capsule with octreotide. The company hopes that RT-101 could potentially treat acromegaly or neuroendocrine tumors.

The company’s RaniPill HC device can hold five times more drug payload than its first oral biologics capsule, also known as the RaniPill GO.

Rani shares dipped 7.49% to $6.55 in early afternoon trading.

The company raised $73 million form its IPO in 2021.

The company will abandon its plans to develop RT-109, a capsule with human growth hormone. A press release notes that it is “open to partnering opportunities with respect to RT-109” but has decided to prioritize other pipeline programs.

Earlier this year, Rani won an innovation award from Fast Company.

Initial investors in Rani Therapeutics included GeneScience Pharmaceuticals and Shire, Alphabet’s GV, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN). Takeda Pharmaceutical acquired Shire in 2019.