BioDexa "eRapa" version of Rapamycin enters phase II Trial

#1

Interesting alt formulation of rapamycin called “eRapa”, entering phase II trial for treatment of Familial Adenomatous Polyposis. So - maybe the fact that rapamycin is off patent doesn’t rule out the profit motive after all?

“eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035,”

Press release:

https://www.globenewswire.com/news-release/2024/04/30/2872564/0/en/Biodexa-s-Licensor-Emtora-to-Announce-Phase-2-Clinical-Trial-Results-of-eRapa-in-Familial-Adenomatous-Polyposis-to-be-Presented-at-Prestigious-2024-Digestive-Disease-Week-Annual-Me.html

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#2

Other uses

About the drug

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#3

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biotechnology company developing a pipeline of treatments aimed at diseases with high unmet clinical need. The company’s lead development programme, eRapa™, is being readied for a phase 3 registration study in familial adenomatous polyposis (FAP), a rare and serious condition where the only successful treatment option is bowel resection. Without effective treatment virtually all FAP patients progress to develop colorectal cancer. The company is also working on treatments for type 1 diabetes and primary and metastatic cancers of the brain.

eRapa™ is a proprietary oral tablet formulation of rapamycin (sirolimus). Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR is known to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis. Rapamycin is approved in the US for organ rejection in renal transplantation. It is very poorly water soluble and current formulations exhibit significant variability in systemic plasma levels. Through the use of nanotechnology and pH sensitive polymers, eRapa™ is designed to improve bioavailability and achieve more consistent pharmacokinetics than existing products.

Biodexa believes eRapa could be the first therapeutic option to treat this precancerous condition, and its data so far backs up that assessment. Results of a 12-month phase 2 clinical trial of eRapa demonstrated an overall 17% median decrease in overall polyp burden and an overall non-progression rate of 75%. Even more compelling, of patients in Cohort 2 (treated daily, alternate weeks), 89% of patients were deemed non-progressors at 12 months, with a median reduction in polyp burden of 29%. That could be gaming-changing for FAP patients if it means fewer surgeries with much improved quality of life. The 12-month data demonstrate a longevity of effect of eRapa.

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#4

Feb 12th, 2025

The Food and Drug Administration (FDA) has granted Fast Track designation to eRapa, an encapsulated form of rapamycin, for the treatment of familial adenomatous polyposis (FAP).

There are currently no FDA-approved treatments for FAP, a condition characterized by the proliferation of polyps in the colon and/or rectum. Encapsulated rapamycin is expected to prevent disease progression by inhibiting mTOR (mammalian Target Of Rapamycin), a protein kinase that has been shown to be overexpressed in FAP polyps.

The Fast Track designation is supported by data from a phase 2 trial (ClinicalTrials.gov Identifier: NCT04230499) that evaluated eRapa in 30 adult patients with FAP. Study participants were assigned to 1 of 3 dosing cohorts (10 patients each). The primary endpoints of the trial were safety and tolerability, as well as the change from baseline in polyp burden at 6 months. Patients received treatment and monitoring for 12 months.

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#5

Phase 3 trial getting ready

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