The capsule contains a formulation of human parathyroid hormone (1-34) analog (PTH).
While there are several medicines available for the prevention of treatment of osteoporosis, PTH has been shown to be an effective anabolic treatment, said Rani. Patients who are currently prescribed PTH must administer injections daily though.
Part 2 is a continuation of Rani’s single-center, open-label Phase 1 trial of RT-102 conducted in Australia. The study evaluated the safety and tolerability of once-daily administration of RT-102 containing 20mcg of PTH given repeatedly for seven consecutive days in 10 healthy female volunteers, five of whom were post-menopausal.
Complete pharmacokinetic profiles of PTH were obtained for each subject on day 7.
The readout showed RT-102 delivered PTH to subjects with a 91% success rate and demonstrated high bioavailability, reported the San Jose, California headquartered developer.
The study achieved all its endpoints, with repeat doses of RT-102 being generally well tolerated, added the company.
“The data are highly encouraging and reinforce the tolerability and high bioavailability of RT-102 that was observed in Part 1 of the study,” said Mir Hashim, CSO of Rani. “The RaniPill GO capsule continues to deliver drug payloads to subjects at success rates exceeding 90%. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase 1 study support the initiation of a Phase 2 trial of RT-102 in osteoporosis, which we anticipate beginning in the second half of 2023.”
A deeper dive into the data
None of the participants withdrew from the repeat-dose study due to any adverse event related to the RaniPill capsule or due to difficulty swallowing it. Two subjects had transient, mild-to-moderate adverse events which resolved without any intervention, while device remnants were excreted without sequelae in all subjects, said the company.
In all 10 participants who completed seven days of daily, consecutive dosing, the RaniPill capsule demonstrated an overall drug delivery success rate of 91% over the seven days - drug sampling was done at three, six and nine hours after capsule swallowing on days 1-6, as per the findings.
On day 7, with more frequent, serial drug sampling after capsule swallowing on that day, the drug delivery success rate was 100%. On days 1 through 6, participants ate food three hours after administration of the capsule. The number of successful deployments was comparable before and after food was consumed, said the US innovator.
RT-102 delivered 20mcg of PTH with high bioavailability, and the data indicate that PTH delivered via RT-102 may be efficacious at doses lower than 20mcg, noted Rani.
‘Comparable to or better than subcutaneous injection’
With these data, in total, 185 RaniPill GO capsules have now been administered to more than 90 participants in clinical studies, in addition to over 1,700 RaniPill capsules administered to animals in preclinical studies, said the company. In the clinical studies, the RaniPill capsule has been well tolerated and delivered its drug payload with high reliability and with bioavailability comparable to or better than subcutaneous injection, it added.
“The repeat-dose data contribute to our growing body of preclinical and clinical data that we believe support the viability of the RaniPill platform to orally deliver biologics and drugs to treat chronic diseases,” said Talat Imran, CEO of Rani. “These data give us confidence to move forward with multiple programs in parallel, including our ustekinumab biosimilar and adalimumab biosimilar programs, and to expand manufacturing scale-up. We can see a future where millions of patients no longer carry the burden of regular injections.”