At the end of January, Aequus Pharmaceuticals (TSX-V: AQS) (OTCQB: AQSZF), in collaboration with Camargo Pharmaceutical Services, began preparing for a pre-Investigational New Drug application meeting with the U.S. Food and Drug Administration regarding its AQS1303, a transdermal patch for pregnancy-related anti-nausea. The prep work followed positive data on the patch in a small proof-of-concept study.
It’s estimated that up to 70% of women experience nausea and vomiting during pregnancy.
On Tuesday, Aequus said it has moved a step closer towards clinical research on AQS1303 by completing a payment to Camargo for its work on the pre-IND application. The submission has been made, with the company expecting a response from the FDA by the end of the month. For its efforts, Aequus issued Camargo 120,11 shares of its AQS common stock.
Aequus anticipates utilizing the FDA’s 505(b)(2) pathway for the clinical development of AQS1303. 505(b)(2) is an regulatory strategy that allows a drug developer to leverage previous clinical data on the active moiety of new drug candidate to shorten clinical studies. Aequus is seeking a meeting with the FDA to better define what the regulator wants to see in order for Aequus to get its blessing to go the 505(b)(2) route.
The Vancouver-based specialty pharma’s patch contains the combination of pyridoxine hydrochloride and doxylamine succinate, the active ingredients in branded morning sickness drugs, including Diclegis, which generated sales of $120 million in 2015.
Because it is the same active ingredient as already FDA-approved drug, Aequus hopes it won’t have to conduct typical research to prove the safety and efficacy profile to the FDA now that the P-o-C study provided information on bioavailability of the active ingredients. In the study, AQS1303 was well tolerated with no serious adverse events reported.
Sustained delivery via the patch is beleived to be a far more convenient drug delivery method than the FDA-approved oral versions that requires dosing up to four times daily. Transdermal delivery also addresses issues of potential loss of therapeutic benefit due to vomiting reducing the uptake of the active ingredient.
Investors are taking the payment news in stride today, with Toronto-listed shares of Aequus trading flat at 26 cents in early Tuesday action.
