- Transenteric delivery of incretin triagonist of GLP-1, GIP, glucagon receptors elicits rapid weight loss in animal study –
- Preclinical data support the potential for the RaniPill platform to enable oral delivery of multiple obesity treatments -
“The preclinical data announced today are highly encouraging, as the data highlights that transenteric delivery mimicking the RaniPill’s route of drug administration results in pharmacodynamics comparable to subcutaneous injection for an incretin triagonist,” said
Data Highlights
The recent preclinical study evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of an incretin triagonist (GLP-1, GIP, glucagon receptors) when delivered via an endoscope-guided transenteric administration to mimic the RaniPill route of administration, versus the traditional administration route of subcutaneous (SC) injection. The study was conducted in canines separated into two groups. In Group 1 (N=5), 0.12 mg/kg of drug was administered via transenteric delivery by endoscope. In Group 2 (N=5), 0.12 mg/kg of drug was administered by subcutaneous injection. Blood samples were collected over 2 weeks for analysis of serum drug concentrations and various PD and safety biomarkers.
A single dose of drug delivered via either transenteric or SC routes elicited rapid decreases in body weight and serum lipids. Weight loss is believed to be due to early satiety leading to reduced caloric intake. The drug was well tolerated in both groups with no serious adverse events (SAEs) observed or changes in safety markers examined.
Near-Term Milestone Expectations:
- Initiation of Phase 2 clinical trial of RT-102, a RaniPill GO containing teriparatide for osteoporosis, expected in 2024.
- Topline results of Phase 1 clinical trial of RT-111, a RaniPill GO containing ustekinumab biosimilar CT-P43, expected in the first quarter of 2024.
- Development of RaniPill HC to be ready for potential Phase 1 clinical trials in the second half of 2024.
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the expected initiation of a Phase 2 clinical trial of RT-102 in 2024, the potential opportunity for the RaniPill platform to support oral delivery of multiple obesity drug products, the expected timing of topline results from the RT-111 Phase 1 clinical trial in the first quarter of 2024, the expected readiness of the RaniPill HC for clinical development in the second half of 2024, the potential for the transenteric delivery via endoscope of an incretin triagonist to mimic the RaniPill route of delivery, the likelihood that weight loss in the preclinical study of the incretin triagonist was caused by early satiety leading to reduced caloric intake, the belief that the preclinical data are reflective of the potential contributions the RaniPill capsule can make to the GLP-1 receptor agonist space and the broader obesity market, and the potential for Rani to use the RaniPill platform to create oral alternatives for single and multiagonist drugs with differentiated dosing flexibility. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “potential,” “expected,” “believed” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rani’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rani’s business in general and the other risks described in Rani’s filings with the
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Investor Contact:
investors@ranitherapeutics.com
Media Contact:
media@ranitherapeutics.com
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Peak Decreases in Body Weights
All data are means ± SE
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