The Science
A multi-target intervention
against the oxidative cascade driving
diabetic peripheral neuropathy.
EP-001 engages eight upstream targets in the neuropathy cascade — validated first in silico, then confirmed in vitro on human neurons under hyperglycemic stress.
Where existing drugs stop
Diabetic neuropathy sits downstream of six interacting pathways at least. Every first-line drug treats one of them.
The biology needs a set of validated interventions delivered together, hitting the same cell at the same time. Difficult to build inside a single synthetic molecule. What a standardised botanical matrix delivers by construction.
In silico · Multi-target coverage
EP-001 was validated computationally against eight upstream targets across the neuropathy cascade.
Citations link to open-domain literature establishing each target’s role. Earthpharm’s binding profile and per-target mechanistic detail are reserved for partner conversations under NDA.
In vitro · Signal
Tested on human neurons under hyperglycemic oxidative stress — the actual disease event.
Neuronal survival
Mitochondrial restoration
Apoptosis
Complete dataset available under scientific NDA.
Delivery
Delivered orally through a proprietary sub-100nm nanocarrier system.
Sub-100nm particles cross membrane barriers that stop conventional oral formulations. Encapsulation shields the actives from first-pass metabolism. Peripheral nerve tissue gets the delivered dose, not what’s left of it.
The nanocarrier is proprietary and part of the Earthpharm IP estate under counsel.
Where the programme is now
Preclinical. In-vivo model entering setup this quarter. IND-enabling toxicology follows.
Regulatory strategy runs on two parallel tracks — CDSCO Phytopharmaceutical for India, FDA 505(b)(2) for out-licensing. The datasets do double duty across both.