Clinical Research


After 5 years of preclinical development in rats and dogs, including studies of toxicology, drug safety, pharmacokinetics and genotoxicity, Algenis has an “Investigational New Drug” (IND) active in the USA (FDA) since 2015 for its leader product NAVX-010 (Gonyautoxin), which first indication is the treatment of anal fissure.

This means that they have the permission of the North American organization Food and Drug Administration (FDA) to administer an experimental drug in humans.

Study
Title
Type
N° of patients
Status
SAD (Chile)
Safety study of GTX2 / 3 intramuscularly in healthy volunteers.
SAFETY
20
COMPLETED

SAD (Chile)

The objective of the study was to determine the safety profile of GTX2 / 3 after a single administration in 20 volunteers.

SAD (USA)
NAVX-010 A Phase I, double blind, placebo-controlled, single-dose, safety, tolerability and pharmacokinetic study in healthy male subjects.
SAFETY
30
COMPLETED

SAD (USA)

The main purpose was to establish the safety of a single injection in healthy subjects. The secondary objective was to determine the pharmacokinetics (which studies the course of a drug since it enters the body) of GTX 2 and 3 after an injection.  30 male subjects participated, which were divided into five groups.

MAD (USA)
NAVX-010 A Phase I, double blind, aleatory, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of NAVX-010 intra-anal injections in subjects with chronic anal fissure.
SAFETY
40
ONGOING

MAD (USA)

This clinical trial seeks to determine the safety of the drug in multiple injections in subjects with chronic anal fissure. The secondary objectives are to determine the pharmacokinetics of GTX 2 and 3 after multiple intra-anal injections are applied. The study consists of 40 patients divided into four groups.

EFFICACY (CHILE)
NAVX-010 – A safety and efficacy study of GTX2/3 in the treatment of anal fissure in adult patients. Randomized, double blind placebo-controlled study. Study CLN 13-025.
SAFETY AND EFFICACY
80
ONGOING

EFFICACY (CHILE)

The main objective is to determine the efficacy of NAVX-010 after multiple intra-anal injections in patients with chronic anal fissure. The secondary objective is to determine the tolerance of the drug.

After 5 years of preclinical development in rats and dogs, including studies of toxicology, drug safety, pharmacokinetics and genotoxicity, Algenis has an “Investigational New Drug” (IND) active in the USA (FDA) since 2015 for its leader product NAVX-010 (Gonyautoxin), which first indication is the treatment of anal fissure.

This means that they have the permission of the North American organization Food and Drug Administration (FDA) to administer an experimental drug in humans.

Study
Title
SAD (Chile)
Safety study of GTX2 / 3 intramuscularly in healthy volunteers.

SAD (Chile)

The objective of the study was to determine the safety profile of GTX2 / 3 after a single administration in 20 volunteers.

Type

SAFETY

N° of patients:

20

Status

COMPLETED

SAD (USA)
NAVX-010 A Phase I, double blind, placebo-controlled, single-dose, safety, tolerability and pharmacokinetic study in healthy male subjects.

SAD (USA)

The main purpose was to establish the safety of a single injection in healthy subjects. The secondary objective was to determine the pharmacokinetics (which studies the course of a drug since it enters the body) of GTX 2 and 3 after an injection.  30 male subjects participated, which were divided into five groups.

Type

SAFETY

N° of patients:

30

Status

COMPLETED

MAD (USA)
NAVX-010 A Phase I, double blind, aleatory, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of NAVX-010 intra-anal injections in subjects with chronic anal fissure.

MAD (USA)

This clinical trial seeks to determine the safety of the drug in multiple injections in subjects with chronic anal fissure. The secondary objectives are to determine the pharmacokinetics of GTX 2 and 3 after multiple intra-anal injections are applied. The study consists of 40 patients divided into four groups.

Type

SAFETY

N° of patients:

40

Status

ONGOING

EFFICACY (CHILE)
NAVX-010 – A safety and efficacy study of GTX2/3 in the treatment of anal fissure in adult patients. Randomized, double blind placebo-controlled study. Study CLN 13-025.

EFFICACY (CHILE)

The main objective is to determine the efficacy of NAVX-010 after multiple intra-anal injections in patients with chronic anal fissure. The secondary objective is to determine the tolerance of the drug.

Type

SAFETY AND EFFICACY

N° of patients:

80

Status

ONGOING