Rani Therapeutics, a leader in oral biologics, has 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. The plan is to conduct a proper head-to-head study in the coming year and demonstrate equivalence or non-inferiority to the injectable version. The earliest Rani Therapeutics expects the product to be available, assuming all goes well clinically, is 2022.  It’s also of interest that Novartis (Octreotide manufacturer) is said to be a partner in the development, mainly via funding to support clinical trials.

How does it work?

The RaniPill, as it is called, looks like a larger version of a normal pill. When swallowed, it passes through the stomach untouched. The outer covering only dissolves in the less acidic environment of the intestine. When this happens, a tiny balloon inflates and pushes a small needle into the muscular wall of the intestine that injects the drug the pill is carrying. The balloon then deflates and the remains of the pill are excreted. The intestine has no receptors for sharp pain and heals very quickly. “It’s completely pain-free,” says Mir Imran, the head of Rani Therapeutics of San Jose, California. “Not a single subject felt anything.” 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. In addition to the picture below, check out the animated video from Rani Therapeutics – click here

Further reading:

1.  Click here for Rani Therapeutics website.
2.  Read the article in the New Scientist – click here.
3.  For other delivery mechanisms in the pipeline for somatostatin analogues, please click here.
4.  Clinical Trial Document – click here.