Our pipeline includes five core product candidate programs. Additionally, we envision complementing these core programs with robust partnering activities to maximize the value inherent in the RaniPill capsule. Below is a summary of our product candidate pipeline.
RT-101 is the original RaniPill capsule containing octreotide for the treatment of acromegaly and/or neuroendocrine tumors, or NETs. In 2019, we evaluated RT-101 in a Phase 1 clinical trial in healthy volunteers. RT-101 was shown to be safe and tolerable with no serious adverse events. Bioavailability was found to be on par with the subcutaneous control.
RT-102 is the original RaniPill capsule containing the parathyroid hormone analog PTH(1-34) for the treatment of osteoporosis. There are several medications available for the prevention or treatment of osteoporosis; PTH has been shown to be an effective anabolic treatment. Currently, Patients who are prescribed PTH must administer injections daily.
We initiated a Phase 1 clinical trial of RT-102 in Q1 2022. A topline readout is expected in 2H 2022.
RT-105 is the original RaniPill capsule containing a TNF-α inhibitor antibody for the treatment of psoriatic arthritis. Several TNF-alpha antibodies, such as adalimumab, have been approved by the FDA and EMA to treat a range of autoimmune conditions, including psoriasis, rheumatoid arthritis and Crohn’s disease. Patients who use adalimumab administer the drug through a painful subcutaneous injection once every two weeks. We plan to initiate a Phase 1 clinical trial of RT-105 in healthy volunteers in 2023 and develop it for the treatment of psoriatic arthritis.
RT-109 is the original RaniPill capsule containing human growth hormone (hGH) for the treatment of growth hormone deficiency. HGH is approved by the FDA for the treatment of growth hormone deficiency. Current treatment with hGH involves daily painful subcutaneous injections. We have entered into an Evaluation and First Right of Refusal Agreement with Changchun High & New Technology Industries, or CCHN, which includes limited rights to negotiate commercialization rights for RT-109 in China.
RT-110 is the original RaniPill capsule containing parathyroid hormone for the treatment of hypoparathyroidism. Hypoparathyroidism is a rare condition of low levels of serum PTH, resulting in low calcium levels in the blood. This condition requires lifelong daily injections but has suboptimal efficacy.
Glucagon-like peptide-1 agonists or GLP-1 mimetics are a class of drugs used in the treatment of Type II diabetes and obesity. Available GLP-1 agonists include exenatide, liraglutide and lixisenatide. Currently, patients must administer a daily or weekly injection. The Rani platform could transform this therapy with daily pills.
Basal insulin or “background insulin” is used in diabetes management as a way to regulate glucose levels in between meals. The RaniPill™ could change the lives of millions of diabetes patients by radically reducing the amount and frequency of injections.
“Millions must take injections to slow the progression of their condition. With pills, compliance is much higher than with injections which helps slow down chronic diseases.”
“I am passionate about changing healthcare and coming up with new solutions that will impact the lives of millions of patients.”
“Given the market demand and potential, it’s no wonder that there have been countless attempts and dollars spent by companies to try to convert painful injections into painless pills.”