indica News Bureau-
A efforts to transform injectable drugs into pills seems to turn into reality as a therapeutic company has come very close to the breakthrough by its new invention called Rani Pill.
According to a report in Endpoint News, a California-based Rani Therapeutics on January 30 said that it’s technology, aka, Rani Pill, had succeed in a trial performed on 52 healthy adult volunteers. The company is led by Mir Iman.
The Rani Pill works on the body’s natural mechanism that helps absorb the nutrients form food in the intestine.
Once swallowed, the pill has an enteric coating that protects it from the acidic environment 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 micro-needle 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.
The break-though will come as a blessing for the people who are scared of needles and try to avoid it at all costs.
“It’s completely pain-free,” says Mir Imran, the head of Rani Therapeutics of San Jose, California. “Not a single subject felt anything.”
Imran says that one in 10 people have a fear of needles, and the Rani Pill- which is bigger in size than a normal pill- will provide hope for several diabetic patients who wish to have an alternative to painful insulin injections.
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.
In an interview with Endpoints News, Imran said, “This was the first time we were delivering needles from the intestinal wall. 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. According to Imran, the product is likely to be available by 2022, if all goes well.
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 website reported.
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.