RaniPill passes Phase I test for orally delivered biologics
The study reached both its primary and secondary endpoints, in determining the safety and tolerability of octreotide delivered through RaniPill drug delivery.
In terms of bioavailability of the therapeutic, the results found that rates were greater than 70%, the company stated.
Octreotide is usually delivered via injection with the drug acting in a similar fashion to hormone somatostatin, which is naturally produced in the body. The treatment is used to treat acromegaly, as well as to treat severe diarrhea and flushing caused by cancer.
The RaniPill is a ‘robotic pill’ that is able to pass through the stomach without being broken down by stomach acid, instead delivering its payload once the pill reaches the intestinal wall.
The pill coating dissolves due to the pH level of the intestine, with a chemical reaction causing a balloon to inflate and push microneedles into the intestinal wall. As there are no sharp-pain receptors in the intestine, the treatment is delivered painlessly.
A 2016 study found that 17.7% of men and 16.8% of women suffered from a phobia of needles, otherwise known as trypanophobia.
As such, CEO of Rani Therapeutics, Mir Imran stated, “This study brings hope for the millions of patients who have long demanded an effective, alternative to painful recurring injections.”
In addition, he noted that patient adherence to pills is higher in comparison to injections to treat chronic disease.
The company has signed a partnership agreement with Novartis to test whether the technology can be used to deliver biologic treatments within the latter’s portfolio.
Given that sales of Sandostatin LAR are expected to take a hit with the entrance of generic competition, having a delivery differentiator could make a competitive difference for Novartis to retain its market share.
Wider than octreotide, Rani Therapeutics is also looking to investigate RaniPill’s use in conjunction with the delivery of insulin, human growth hormone, and interleukin antibodies, as well as other treatments.