Rani Therapeutics Announces Positive Phase I Study Results of Oral Octreotide using RaniPill™

Study Met All Primary and Secondary Endpoints

SAN JOSE, CA, USA I January 30, 2020 IRani Therapeutics, the leader in oral biologics, has today announced positive results from the Phase I clinical study of its orally-delivered version of octreotide, Octreotide-RP, a drug used in the treatment of acromegaly and neuroendocrine tumors. The Phase I study successfully achieved both its primary and secondary endpoints, demonstrating the safety and tolerability of Octreotide-RP, the RaniPill™ loaded with octreotide, and high oral bioavailability of the biologic drug.

The Phase I clinical study of Octreotide-RP was conducted in Australia with 58 healthy adult volunteers. The test group was comprised of both male and female subjects aged 18 to 55. Of the 58 participants, 52 were treated with Octreotide-RP, while a control group of 6 participants was given an intravenous injection of an identical dose of octreotide. Results of the study demonstrated that the bioavailability of Octreotide-RP was greater than 70%. No serious adverse events were reported for any subject in the study.

"This study brings hope for the millions of patients who have long demanded an effective, alternative to painful recurring injections," said Mir Imran, Rani Therapeutics' Chairman and CEO. "We have demonstrated that we can safely and effectively deliver biologic drugs orally using the RaniPill™ platform, and we are now one step closer to making recurring injections for chronic diseases a thing of the past."

"Current octreotide delivery methods compel patients to choose between painful injections and living with debilitating symptoms especially occurring at the end of injection cycles. By providing an oral alternative like Octreotide-RP, Rani Therapeutics is making therapy easier and painless for patients, a welcome change for acromegaly and neuroendocrine tumor patients," said Dr. Shlomo Melmed, Executive Vice President of Academic Affairs, Dean of the Medical Faculty and Professor of Medicine at Cedars Sinai.

"The human results with octreotide are compelling and demonstrate the safety and efficacy of the RaniPill™, a major milestone for Rani but also a first for the industry," added Dennis Ausiello, M.D., Physician-in-Chief, Emeritus at Massachusetts General Hospital and Jackson Distinguished Professor of Clinical Medicine at Harvard Medical School, and Rani Therapeutics board member. "This human study is the proof-of-concept for the platform, and we are confident that we will see similar results with any biologic drug, from insulin to Humira."

In addition to oral octreotide, Rani has a pipeline of drugs for the treatment of diabetes, osteoporosis, and rheumatoid arthritis, among other diseases.  Rani's goal is to transform the lives of millions of patients around the globe by replacing painful injections with pills.

About Rani Therapeutics
Rani Therapeutics has developed the RaniPill™, a platform technology for the oral delivery of biologic drugs. The company has demonstrated bioavailability similar to subcutaneous injections in both preclinical and clinical studies. The research and technology behind Rani Therapeutics came out of InCube Labs, a multi-disciplinary life sciences R&D lab focused on breakthrough medical innovations. InCube is led by Mir Imran, a prolific medical inventor, entrepreneur, and investor.  Rani has active collaborations with Novartis and Takeda. For more information, please visit www.ranitherapeutics.com.

SOURCE: Rani Therapeutics

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