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VECAM: A combination of any PPI together with a chemical acid pump activator that
targets robust, meal-independent, 24h and night time gastric acid suppression with
bed-time administration.
To identify meal substitution agents (acid pump activators) that are capable of maximizing
PPI activity,
VECTA screened and selected several small molecule, indogenous chemical entities (SMEs) that have shown
proton pump activation capacity in humans. Among the tested molecules, VECTA selected
VB101 that, upon oral administration in humans, exhibits activity similar
to pentagastrin (s.c.), a benchmark for proton pump activation.
We found that VB101, in conjunction with any PPI, enhanced acid suppression activity of the PPI in vivo.
Based on this discovery, VECTA has begun to develop the proprietary drug VECAM
a combination of any PPI with VB101. VECAM reduces gastric acid
secretion quickly in a
meal-independent manner, targeting numerous acid-related disorders, e.g. nocturnal GERD, other GERD symptoms, Erosive Esophagitis and peptic ulceration.
VB101 is approved by the FDA as a pharmaceutical excipient. The Maximum Recommended Therapeutic Dose of VB101, reported by the FDA, is 100 mg/kg-bw/day. VB101 salt (i.v. formulation) was previously approved
by the FDA as a generic drug. VB101 is designated by the FDA as GRAS
(generally recognized as safe) and is used in several nutraceutical formulations.
The doses of PPI and VB101 in VECAM formulation do not exceed
the doses already approved by the FDA.
VECAM provides a simple solution to unmet medical needs in the use of PPI,
allowing meal independent administration bedtime administration for the treatment of nocturnal GERD symptoms, healing of ersosive esophagitis (EE) and maintanance of gastric pH>4 for 24h.
VECAM Drug Product Highlights:
- Unique nighttime control of GERD symptoms
- PPI effect optimized by eliminating a dependency on meals
- Enables optimal bedtime administration
- Fast relief of acid reflux from the first administration
- Early steady state
- Excellent patient compliance (meal independent administration)
- A solid oral dosage form containing any PPI and VB101
Regulatory Approach
Following the successful completion of POC clinical trials, VECTA has received encouragement from the US FDA in a Pre-IND Meeting to advance the product rapidly to Phase III trials under 505(b)(2) regulations. VECTA is targeting the unmet clinical need for the control of nocturnal heartburn symptoms as well as treating 24 hour GERD symptoms and controlling Erosive Esophagitis. VECTA has filed an IND application and began a series of pharmacodynamic (ClinicalTrials.gov Identifier:NCT00818870) and Phase IIb clinical trials (ClinicalTrials.gov Identifier:NCT01059383)for VECAM pivotal studies.
Market Opportunity
VECAM represents a unique and significant partnership opportunity for any pharmaceutical company with an existing or strategic interest in the GI marketplace. The opportunity may be particularly attractive to those companies, which are, or would like to participate in the market segments dominated by PPI’s. Generic competition within the PPI class, the unique label and positioning of VECAM , with demonstrable advantages in the GERD population, is expected to generate significant dollar revenues in the Rx as well as OTC market.
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