The firm says the injection-free technology – manufactured at its facilities in San Jose, California – is designed to deliver biologics such as TNFα inhibitors, interleukin antibodies, basal insulin and GLP-1, without exposing the drug the digestive enzymes.
The drug is contained inside a tiny, hollowed, dissolvable needle, assembled into a balloon-like structure, and folded in the capsule.
Once the RaniPill is consumed, the drug stays protected until it enters the small intestine and delivers the medication into the intestinal wall.
The capsule is enteric coated with a pH sensitive coating, designed to allow it to pass through the stomach without degradation, to reach the small intestine.
“Once the capsule goes past the duodenum, the pH rises above 6.5, the outer shell/enteric coating dissolves, initiating a chemical reaction to produce a gas inside the balloon,” said CEO Mir Imran.
“The balloon inflation pushes a microneedle containing the drug into the highly vascularized intestinal wall, which absorbs the drug very quickly,” he added.
The firm said there are no sharp-pain receptors in the intestine, which renders the injection painless.
Once the needle is delivered, Rani said all is left is a deflated polymer – which it likened to the consistency of a tomato skin – that the patient passes out.
“We selected FDA approved injectable and ingestible materials that are either safely absorbed or easily passed out of the body,” Imran told us.
Big Pharma interest
Rani said it believes this approach will enable the delivery of biologics of any molecular weight, regardless of its structure or properties.
“We believe this approach will allow us to deliver biologics of any molecular weight regardless of its structure or properties.
“So not only small peptides and proteins, but even therapeutic antibodies can easily be delivered with the RaniPill,” we were told.
The firm is conducting feasibility studies in preclinical models with partner molecules.
“We have collaborations with Novartis, MedImmune – the biologics arms of AstraZeneca – and Shire,” said Imran.
According to the company, there are no oral delivery technologies like the RaniPill on the market.
“Prior approaches to oral delivery have relied on blocking the enzymes in the intestines to protect the biologic drug…this strategy has resulted in bioavailability in the low single digits, making these approaches impractical.
“In contrast, the RaniPill delivery achieves bioavailability equal to a subcutaneous injection,” Imran told us.
The firm has 45 patent issues to date, with additional applications pending.