Interview – Rani’s pill injector promises much, but is still preclinical

Rani Therapeutics claims that upwards of 90% of patients taking injected biologicals for chronic diseases would, given the choice, switch to pills. It further claims that its robotic pill technology will allow patients to make such a switch, and seems to have convinced investors, closing a sizeable venture round despite its technology having not yet entered human trials.

“We’ve raised $53m, and if we had wanted to raise more there was more money around the table,” Mir Imran, Rani’s chief executive, tells EP Vantage. Remarkably, considering the complexity of the technology, the company claims that it will cost the same or less than pen injectors, and that consequently payers will swiftly fall in line with patients’ wishes.

The device, called RaniPill, is a capsule that is resistant to stomach acid and digestive enzymes until it reaches the intestine. At that point its coating dissolves, triggering a chemical reaction that produces carbon dioxide, which inflates a small balloon. This in turn pushes tiny needles formed of complex sugar molecules into the intestinal wall. These needles contain the biological drug in solid form.

Rewards

This might sound like a Heath Robinson contraption, but all other attempts to deliver protein-based drugs orally have failed. The rewards for the first company to crack this are enormous, a detail neatly illustrated by the fact that Rani counts Novartis, Shire and Astrazeneca among its venture investors. It is also working closely with them on research.

“One strategy is to partner with them, and license the [RaniPill] platform once they are satisfied with the performance, so they will have the platform for a specific drug,” Mr Imran says.

No licences have yet been signed, Mr Imran explains. “We’re taking their drug, testing it in animal models, and giving them the data. Starting this year, we will sit down and negotiate a licence, and after that there will be the traditional agreements where you have a fee and milestones followed by royalties.”

This will be hugely advantageous to the pharma partner, Mr Imran claims: “Whoever has this platform will end up becoming the market leader.” It seems reasonable that RaniPill could confer a competitive advantage, though maybe not one that dramatic, and the implications for extending the life of a biological about to face biosimilar competition are obvious.

The mark of the Rani

The company’s other drug development strategy is to buy in several off-patent drugs and develop these with RaniPill internally. Mr Imran says this too is progressing well. Reading between the lines, the company appears to be working on, or at least considering, a formulation of Abbvie’s blockbuster antiarthritic Humira, which is due to come off patent in 2023.

The company has done a survey specifically for adalimumab – Humira’s generic ingredient – asking 500 patients whether they would switch from the current bimonthly injection to a daily pill; 90% said they would. 90% of the doctors Rani canvassed said they would be happy to prescribe the pill.

This is all fine, but there is no getting away from the fact that the technology has simply not been studied in humans. Mr Imran seems to think that clinical studies will be little more than a formality.

For drugs that are already approved, he says, the company will have to prove that the new form is safe for repeat dosing and has an equivalent pharmacokinetic profile to the current administration route. This might require careful calibration: the intestinal wall is highly vascularised, and Mr Imran says in animal trials of an unspecified drug the absorption was actually “10-15% better” than an injected comparator.

“Based on our preclinical work we’re pretty confident that we’ll be able to demonstrate safety and efficacy in human studies. And they shouldn’t be very large, we think, for approved drugs,” Mr Imran says. Human trials are due to start this year; he declines to give a possible date for the first product to reach the market.

Pricing

The latest tranche of funding ought to see Rani through to getting some of its internal drug molecules to market, Mr Imran says. Whether further venture investment will be necessary depends on whether the licences kick in as expected.

“We will be left with this question some time next year to see if we should do another round of equity,” he says.

As for the long-term future of the group, Mr Imran says the participation of pharma companies in Rani's funding is not a precursor to a buyout – because none of them can afford it.

RaniPill is applicable to such a broad array of drugs – as well as Humira he names basal insulin, parathyroid hormone and interferon beta, and adds that there are 15 or 20 more candidates – that “no one pharma company can adequately pay the value of Rani”.

Success on this kind of scale will require human trials and the health economic argument to work. Mr Imran says 30 RaniPills can be produced for the same price as a pen injector designed to deliver a month’s worth of injected drug. But here, as in the clinic, further proof is needed.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizVantage on Twitter