Analyst Outlook
Pyridorin’s (pyridoxamine; NephroGenex) trial program has been put on hold due to company finances
and lack of investor/partner interest, so could well be suspended. Datamonitor Healthcare includes the
drug here for completeness, since development has not yet been technically terminated. Pyridorin has
had several issues during its development. On the positive side, unlike other advanced competitors, its
Phase II trial showed evidence for a benefit of a change in creatinine, which is more directly related to
the Phase III endpoint than urinary albumin-to-creatinine ratio (UACR). However, there was no
difference on the measure in the overall trial, only in subgroup analyses. In addition, the initial pivotal
trial was testing patients with relatively high albuminuria levels, potentially greatly limiting its market
size. There is also a commercial issue that supplements with the same active ingredient are currently
available. Finally, NephroGenex would potentially be facing three major competitors with a great deal
of marketing experience.
Drug Overview
Pyridorin is a metabolic isomer of vitamin B6. It inhibits the formation of advanced glycosylation end
products (AGEs) (AGE formation is considered as a part of the normal aging process) via the following
mechanisms:
– Inactivating toxic carbonyl compounds and reactive oxygen species.
– Inhibiting the conversion of post-Amadori intermediates to AGEs by interfering with the redox metal
ions catalyzing the reaction.
AGEs are thought to be involved in the pathogenesis of diabetic nephropathy (DN) (Biomedtracker,
2016; Medtrack, 2016; NephroGenex, 2015, 2016).
Pyridorin is currently in Phase III development in the US and EU for the treatment of DN
(ClinicalTrials.gov identifier: NCT02065791).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Pyridorin : Diabetic nephropathy
LIST OF FIGURES
10 Figure 1: Pyridorin for diabetic nephropathy – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary for Pyridorin in diabetic
nephropathy
12 Figure 3: Datamonitor Healthcare’s drug assessment summary for Pyridorin in diabetic
nephropathy
LIST OF TABLES
4 Table 1: Pyridorin drug profile
7 Table 2: Pyridorin Phase III trials in diabetic nephropathy
9 Table 3: Pyridorin Phase IIb results in diabetic nephropathy