Robotic Pills That Replace Biologic Injections
If you have Internet access that allows you to read this article, then you’ve probably had an injection at some point in your life. According to the World Health Organization, there are 16 billion injections that take place every year in developing and transitional countries. Of those injections, 90% are therapeutic, 5% are given for immunization and 5% for contraceptive and other purposes. Unsafe injection practices result in patients acquiring nasty things like Hepatitis B/C or HIV. One study estimates that more than 500,000 people died from unsafe injections in the year 2000. Every international dollar invested in injection safety results in 14 dollars in savings. Saving money + saving lives = easy-to-digest value proposition.
They say that an entrepreneur ought to understand their business model well enough such that they can explain the value proposition to a nine-year-old. In the case of Rani Therapeutics, their value proposition is very easy to digest. Literally. Here it is.
Remember when you went to the doctor and he injected you with that needle and you cried, sweetie? Well, Rani Therapeutics is developing some robotic pills that let you take that medicine in the form of a pill instead of an injection. Isn’t that nice? Now run along and leave mommy alone so she can get back to writing this article.
Converting Biologic Injectables Into Pills
Founded in 2012, San Francisco startup Rani Therapeutics has taken in $142.5 million in funding from a whole slew of investors that include names like AstraZeneca, Shire, Novartis, and even Google. Rani wants to improve the lives of millions of patients suffering from chronic conditions by replacing painful injections with an easy and pain-free robotic pill that is designed to replace injections of large drug molecules including peptides, proteins, and antibodies. The pharma industry has been searching for decades to convert injectables into pills, and Rani has demonstrated in preclinical studies a delivery equivalent to subcutaneous injections with several molecules using robotic pills to inject drugs into the intestine.
In order to understand how the robotic pill works, we’ll let Rani Therapeutics explain:
The RaniPill capsule has a special enteric coating that protects itself in the acidic environment of the stomach. When the capsule moves into the intestine and pH levels rise, the enteric coating dissolves and a chemical reaction takes place which inflates a balloon. The pressure in the balloon pushes the dissolvable microneedle filled with the drug into the intestinal wall. The uptake of the drug is immediate due to the highly vascularized intestinal wall. Because there are no sharp pain receptors in the intestine, the injection is painless.
Here’s a look at the capsule in action.
The company goes on to say:
The RaniPill capsule uses no metal, springs or other elements that the body cannot easily absorb or pass quickly. The company’s more than 100 pre-clinical studies, including the testing of more than 1,000 capsules in animal models, and its recent human study, have shown that large animals and humans are able to pass the remnants of the RaniPill capsule within 1-4 days
This delivery mechanism promises to address a problem that the healthcare industry has been trying to solve for decades – the ability to convert injectables into pills. The company says it’s the “holy grail of drug delivery,” and whenever you hear a company talk about how they’re developing “the holy grail” of anything, it’s always useful to look at who is making that claim. It helps when the person who is developing the technology has a successful track record of bringing new technologies to market. It helps if your Chairman and CEO happens to be Mir Imran.
An Experienced Leader in Mir Imran
If you want to feel depressed about what you’ve managed to accomplish in life so far, you may want to stop reading now. That’s because the man behind Rani Therapeutics, Mir Imran, has a bio that makes you wonder how he was able to accomplish so much in the 62 years he’s spent on this planet. During that time, Mr. Imran founded more than 20 life sciences companies, 15 of which have seen liquidity events through IPOs or acquisitions. He holds more than 400 issued patents and is known for his pioneering contributions to the first FDA-approved automatic implantable cardioverter defibrillator. In short, this is the sort of person you believe when they start talking about how they plan to “transform the medical industry” with what they’re working on.
PharmExec.com published a great article last year by Mir Imran which gives us a peek into the mind of a man who has positively affected millions of patients. He imparts several pieces of advice: go after the big problems and understand the problem before you try to solve it. Many companies have tried to change the drugs being delivered such that they could be administered orally. Not having to change the drugs is key to Mr. Imran’s approach and is what makes it the potential impact so big. Mr. Imran also says take big risks and be willing to fail, offering up as evidence several failed companies in his past. As we’ve seen many times before, the best sounding ideas can result in some of the biggest blowups.
Robotics Pills in Human Trials
So, how are things progressing so far for Rani Therapeutics? As with any new medical device, you first need to demonstrate that it plays nicely and doesn’t harm humans. This past February, Rani Therapeutics announced their first successful trial in humans which focused on the effects of food on the robotic pills. “The study showed similar intestinal deployment times for both fasted and fed subjects, indicating that food does not impact the RaniPill capsule’s performance,” said the company which went on to say that “the next human study will be conducted later this year and will include a drug-filled resorbable needle.” As for initial applications of these robotic pills, the company lists the following.
It’s interesting to see basal injections for diabetics in the list. That’s a pain point we recently touched on in our article about how An Artificial Pancreas for Diabetics is Almost Here.
Solving big difficult problems are often referred to as “moonshots” in that the likelihood of success is very low. Factors that can maximize the likelihood of success include things like easy access to capital, an experienced leader at the helm who understands the commercial side and technical details equally well, and investments from large corporations who may act as initial customers or possibly help facilitate liquidity events. All these factors are what makes Rani Therapeutics such a promising company and reduces the likelihood that they’ll pull an Elizabeth Holmes and end up being punished by having their story told to millions of Americans on a Hulu miniseries.
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