Science
A large amount of newly discovered (roughly 90%) and approved (roughly 40%) small molecule drugs suffer from poor solubility, which limits their effectiveness when delivered orally due to poor absorption from the gastrointestinal (GI) tract. While new drugs are prone to delays (roughly 80%) or even discontinuation (roughly 30%), approved drugs fail to live up to their therapeutic potential due to inferior efficacy, severe side effects, or both. Considering the low success rate (< 10%) of clinical validation across the pharmaceutical industry, improvements must be made to maximize the therapeutic potential of these precious, life-saving therapeutics.
The Problem
Current solubility-enhancing oral drug delivery technologies are compatible with a limited range of drug physicochemical properties (see the chart below). By contrast, VeraMorph's DPOD platform is a nearly universally compatible oral drug delivery system that simplifies the process of formulation optimization and achieves solubility enhancement independent of scale.
The Impact
The limited compatibility of current oral drug delivery technologies hinders critical elements of early stage product development that produce significant financial and clinical risk in late stage clinical validation. (1) It restricts medicinal chemists to compounds that do not maximize potency and specificity for a given disease target, leading to sub-optimal efficacy and safety, respectively.
It requires formulation scientists to develop multiple "fit for purpose" dosages, testing a multitude of formulations and production techniques that can alter clinical outcomes and cause significant delays to clinical translation and market entry. In contrast, the DPOD platform enables broad exploration of medicinal chemistries and simplifies oral dosage design to facilitate rapid optimization of a commercially viable oral solid dosage early in pre-clinical development. This minimizes time to proof of concept (PoC) and first in human (FIH) data, and corresponding financial and clinical risk, while improving the success rate of clinical translation and outcomes.
Formulation Optimization
VeraMorph leverages its innovative oral drug delivery platform technology to rapidly design effective oral dosages of a given drug substance to generate pre-clinical proof of concept data.
Rapid Clinical Trial Supply
VeraMorph has transferred the manufacturing know-how on the platform technology to strategic CMO partners' with GMP production capacity to enable rapid scale-up and clinical translation of new oral dosage formulations. We recommend engaging VeraMorph as early as possible in the product lifecycle to maximize the benefits of the DPOD platform to improve and accelerate clinical translation.
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