Rani gets financial backing to the tune of US$69m as it looks to bring injectable biologics the oral route
The syndicate included several active crossover investors and existing investors.
The latest investment is set to accelerate clinical development of Rani's internal pipeline drugs and allow it to scale up manufacturing.
The market potential of the RaniPill is enormous, said Mir Imran, Rani Therapeutics CEO and founder.
The company’s platform is completely agnostic to the type of biologic being delivered, he told us. “We have successfully demonstrated the delivery of Humira, GLP-1, Insulin, Octreotide, Teriparatide and several other biologics. In preclinical studies, bioavailability is similar to a subcutaneous injection.”
As large and complex molecules, biologics are extremely sensitive to the physical and chemical conditions of the gastrointestinal (GIT) environment, which is why they have been, in the main, restricted to delivery via injection so far.
Rani’s technology is designed, though, to get around many of the obstacles to oral delivery of biologics: “The biologic is protected within the RaniPill capsule until the moment of deployment, at which time it is injected – pain-free – into the wall of the intestines. The gastrointestinal environment is entirely inhospitable to biologics, and the Rani approach completely bypasses these barriers."
And how does the technology compare to that of competitors in this sphere?
“Rani Therapeutics has developed a robotic pill that injects biologics pain-free into the wall of the small intestines. The technology can deliver peptides, proteins and antibodies with bioavailability rivaling a subcutaneous injection. No one else, to our knowledge, can make such a claim. Rani pioneered the entire notion of a swallowable auto-injector capable of delivering a biologic across the GI tract, and we have the patents and clinical data to back it up.”
The CEO outlined how the company has successfully tested nine molecules in preclinical studies and demonstrated in several clinical studies that this novel route of administration would be viable in delivering a monoclonal antibody (Adalimumab), a metabolic drug (GLP-1) and a peptide (Octreotide).
Other company attempts to deliver peptides orally, said Imran, typically rely on chemistry-based approaches to attempt to prevent the GI tract from breaking down the drug and/or permeation enhancers to improve absorption. These approaches achieve bioavailability that is orders of magnitude less than a subcutaneous injection, often <1%, he claims. To overcome this limitation, companies behind such efforts have to dramatically increase the dose, relative to an SC injection, he said.
“This increases the costs, and when coupled with the low bioavailability, increases the dose to dose variability."
In addition to building its own pipeline of drugs, Rani has a partnership with Novartis and is also collaborating with Takeda, whereby it is working on an oral form of Factor VIII.
As regards the timeline for further clinical trials and scale up of manufacturing of the RaniPill, the CEO said following completion of its first successful Phase I study at the end of 2019, additional clinical studies are planned for 2021.
“The current manufacturing scale is sufficient to support our ongoing clinical trial needs, and we expect to have commercial-scale manufacturing in place well before commercialization of the first product.”