Rani Therapeutics eyes potential IPO as robotic pill technology takes shape
Two efforts to transform injectables into robotic pills — a colossal market designed to enhance treatment compliance, diminish the need for physician-led therapeutic administration and placate needle-phobic patients — got off the ground last year. Now, one of these initiatives, led by an inventor who played an influential role in pioneering the first FDA-approved automatic implantable cardioverter defibrillator (ICD) has taken another key step in its quest with a successful early-stage efficacy and safety study.
California-based Rani Therapeutics — under chief Mir Imran who started his first company while in college and currently holds more than 400 issued patents — on Thursday said its technology, christened the RaniPill, had performed as expected in a trial with 58 healthy adult volunteers.
The technology is deceptively simple. The capsule has an enteric coating that protects it from the acidic ambiance of the stomach, and once it moves into the intestine and pH levels rise, the coating dissolves and a chemical reaction takes place which inflates a balloon. Pressure in the balloon pushes a dissolvable microneedle filled with a drug — in this case, the compound octreotide, an off-patent biologic that treats the hormonal disorder acromegaly — into the intestinal wall. Intestines don’t have pain receptors, and the intestinal substrate — which is designed to absorb nutrients — is highly vascularized, making it the ideal location for the drug-engorged injection to deploy.
In the trial, 52 subjects were treated with the RaniPill version of octreotide, while the remaining 6 participants were given an intravenous injection of an identical dose of octreotide.
“This was the first time we were delivering needles from the intestinal wall,” Imran noted in an interview with Endpoints News. “And our hypothesis from the beginning was that you wouldn’t feel anything. And of course, that was borne out. And then the second endpoint was bioavailability, which turned out to be greater than 70%. Which is what exactly we had seen in our preclinical testing.”
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 Imran expects the product to be available, assuming all goes well clinically, is 2022.
This octreotide trial will be the litmus test for its drug-delivery platform, opening the door to a plethora of injectable treatments, from insulin to Humira, and across a wide range of diseases. But there’s a long road ahead. Each drug loaded into the capsule will require a separate study before Rani can petition the FDA for approval.
The company has a number of such drugs in its pipeline, and expects to kick off Phase I studies later in 2020. Founded in 2012, Rani Therapeutics has raised $142 million in funding from a slate of investors including GV (the investment arm of Alphabet), and counts Novartis and Shire (now owned by Takeda) as its partners.
As it ramps up its clinical development, funding is imperative. “The funding never stops. We’re constantly doing that,” Imran said, adding that an IPO is a “distinct possibility” roughly a year from now. The company also expects to announce a new licensing partner by the end of the year or 2021, he said.
Transforming injectables into pills is hardly a novel idea, but a string of pharmaceutical/chemical efforts to evade the enzymes that break down the oral drug before it can be absorbed have largely hit a wall. Apart from the RaniPill, last year an animal study — led by MIT scientists — captured the spotlight for the potential of its blueberry sized robotic pill designed to deliver an insulin shot inside the stomach.
Rat and pig data on the other robotic pill — created by a team of researchers at MIT (including the prolific drug delivery maestro Robert Langer) and Novo Nordisk — has an alternative mechanism of action.
The device, called Soma, encapsulates a needle inside a pill made of compressed freeze-dried insulin that is designed to orient itself when it comes in contact with the stomach lining — inspired by a leopard tortoise, which brandishes a shell that allows the African reptile to right itself if it rolls onto its back.
Upon contact with the wet inner lining of the stomach (which is also devoid of pain receptors), a sugar disk holding the needle in place is dissolved, making way for the needle to release its contents. The product is then engineered to disintegrate and travel harmlessly through the digestive system and eventually be eliminated, the researchers wrote in their report in Science.
“There’s so many patent landmines that we have placed. So we’re not really concerned about MIT or anyone else,” Imran said.