Rani therapeutics announced that the company is expected to IPO within one year

Editor's note: the idea of transforming injection form into oral form is not new, but because biological macromolecules are usually hydrolyzed by enzymes in the gastrointestinal tract, and they are not easily absorbed by the human body through the gastrointestinal tract, the research progress in this field is slow In 2019, Professor Robert Langer of MIT drew lessons from the pill designed by leopard tortoise shell structure, which can successfully acupuncture insulin into the stomach wall, making oral insulin and other macromolecular biological agents possible Today, Rani therapeutics, a California based company, announced that it has outperformed expectations in 58 trials of ranipill, a delivery capsule for biological macromolecules Mr Mir Imran, the company's chief executive, said in an interview that with the acceleration of clinical development of ranipill, Rani needs financial support and is expected to have an IPO within one year Ranipill is the "robot" pill It helps the absorption of biomacromolecules by designing a "micro syringe" in a capsule to inject drugs into gastrointestinal tissues, which is very similar to Professor Langer's strategy Ranipill has an enteric coating on its surface, which ensures that the capsule will not be dissolved by gastric acid when it passes through the stomach When the capsule enters the intestine, the enteric coating is dissolved due to the change of pH value, and a chemical reaction is triggered to make a small balloon in the capsule expand And the inflation of the balloon will produce enough pressure to inject the microneedles made of drugs into the intestinal wall tissue to help the absorption of drugs This capsule does not contain any metals, springs or other ingredients that cannot be absorbed or excreted by the human body When the balloons finish the mission of shooting microneedles, they will automatically deflate and discharge from the body And because there is no receptor for acute pain in the gut, patients will not feel pain Rani has successfully delivered more than 10 biomacromolecules, including antibodies, peptides and proteins, in pig and dog animal models for up to 5 years At the end of February last year, ranipill showed good safety and tolerance in its first human trial Moreover, the experimental results showed that whether the patients were full or empty when taking the capsule, the time for the capsule to play a role in the intestinal tract was similar This means that the food does not affect the function of the capsule Ranipill moves from the stomach to the gut (image source: reference [2]) In a recently announced trial, 52 subjects received ranipill version of octreotide, a drug for acromegaly, while the other six received the same dose of octreotide intravenously The results showed that the bioavailability of ranipill version of octreotide was over 70%, which was consistent with the results of preclinical test If clinical research goes well, the product is expected to be available as early as 2022 The company has a large number of such drugs under development and is expected to start the first phase of research later this year Founded in 2012, Rani has raised $142 million from a number of investors, including GV (formerly Google venture), and has entered into partnerships with Novartis and shire The trial opens the door to the development of oral dosage forms for the treatment of various diseases, including insulin, but each drug in the capsule needs to be studied separately, so there is still a long way to go We expect Rani to break through the oral bottleneck of biological drugs and improve the compliance of patients! reference material: