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 aim was to investigate the safety of intramuscular administration in healthy volunteers. The secondary outcome was to investigate the pharmacokinetic (study of the active ingredient route since it enters the body) of GTX 2&3 after the intramuscular administration. This study was made in 30 healthy volunteers, divided into 5 groups of dosing.

MAD (USA)
NAVX-010 A Phase I, double blind, randomized, 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 30 patients divided into four groups.

EFFICACY (CHILE)
NAVX-010 – Proof of Concept Clinical study (Safety and Efficacy) of the administration of GTX 2&3 to manage pain in Acute Low Back Pain in adults, Double Blind, Randomized, Placebo Controlled Study
SAFETY AND EFFICACY
30
COMPLETED

EFFICACY (CHILE)

Proof of Concept, randomized, double-blind, placebo-controlled study. Carried out with 30 volunteers (15 Active, 15 Placebo), at Hospital San José, Santiago Chile (NCT04799041). The study determined the effect of intramuscular administration of GTX2 / 3 on pain reduction and functional improvement in patients with Acute Lumbago (adults between 18 and 75 years of age), during the first 7 days after treatment. This study had the financial support of the Chilean Development Agency.

EFFICACY (GERMANY)
Cosmetic exploratory study to investigate the effect of the Serum in the reduction of wrinkles.
EFFICACY
12 VOLUNTEERS
COMPLETED

EFFICACY (GERMANY)

Proof of Concept Study in 12 volunteers (43 to 67 years old) to investigate the effect on muscular relaxation and wrinkle reduction when the topical serum is applied in the front head during a period of 28 days.

Proof of Concept Oncoclínicas – Algenis (BRAZIL)
Proof of Concept study evaluating the effects of a NEURO SERUM containing Gonyautoxins, Paralytic Shellfish Poison (PSPs), on objective and subjective symptoms of Chemotherapy Induced Peripheral Neuropathy (CIPN)
SAFETY AND EFFICACY
Part 1: 38 patients + Part 2: 60 patients
ONGOING

Proof of Concept Oncoclínicas – Algenis (BRAZIL)

Proof-of-concept study to evaluate the effect of a NEURO SERUM containing gonyautoxin on safety and tactile sensitivity in patients with chemotherapy-induced peripheral neuropathy (CIPN). This is an exploratory multicenter proof-of-concept study in patients affected by CIPN due to solid tumors. The study will be divided into two parts: Part 1: will evaluate the activity and tolerance of NEURO SERUM and part 2: will compare the activity of NEURO SERUM against Placebo in a randomized cohort. The study is being carried out by the Oncoclinicas S.A. group, one of the largest networks of specialized cancer clinics in Brazil.

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 aim was to investigate the safety of intramuscular administration in healthy volunteers. The secondary outcome was to investigate the pharmacokinetic (study of the active ingredient route since it enters the body) of GTX 2&3 after the intramuscular administration. This study was made in 30 healthy volunteers, divided into 5 groups of dosing.

Type

SAFETY

N° of patients:

30

Status

COMPLETED

MAD (USA)
NAVX-010 A Phase I, double blind, randomized, 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 30 patients divided into four groups.

Type

SAFETY

N° of patients:

40

Status

ONGOING

EFFICACY (CHILE)
NAVX-010 – Proof of Concept Clinical study (Safety and Efficacy) of the administration of GTX 2&3 to manage pain in Acute Low Back Pain in adults, Double Blind, Randomized, Placebo Controlled Study

EFFICACY (CHILE)

Proof of Concept, randomized, double-blind, placebo-controlled study. Carried out with 30 volunteers (15 Active, 15 Placebo), at Hospital San José, Santiago Chile (NCT04799041). The study determined the effect of intramuscular administration of GTX2 / 3 on pain reduction and functional improvement in patients with Acute Lumbago (adults between 18 and 75 years of age), during the first 7 days after treatment. This study had the financial support of the Chilean Development Agency.

Type

SAFETY AND EFFICACY

N° of patients:

30

Status

COMPLETED

EFFICACY (GERMANY)
Cosmetic exploratory study to investigate the effect of the Serum in the reduction of wrinkles.

EFFICACY (GERMANY)

Proof of Concept Study in 12 volunteers (43 to 67 years old) to investigate the effect on muscular relaxation and wrinkle reduction when the topical serum is applied in the front head during a period of 28 days.

Type

EFFICACY

N° of patients:

12 VOLUNTEERS

Status

COMPLETED

Proof of Concept Oncoclínicas – Algenis (BRAZIL)
Proof of Concept study evaluating the effects of a NEURO SERUM containing Gonyautoxins, Paralytic Shellfish Poison (PSPs), on objective and subjective symptoms of Chemotherapy Induced Peripheral Neuropathy (CIPN)

Proof of Concept Oncoclínicas – Algenis (BRAZIL)

Proof-of-concept study to evaluate the effect of a NEURO SERUM containing gonyautoxin on safety and tactile sensitivity in patients with chemotherapy-induced peripheral neuropathy (CIPN). This is an exploratory multicenter proof-of-concept study in patients affected by CIPN due to solid tumors. The study will be divided into two parts: Part 1: will evaluate the activity and tolerance of NEURO SERUM and part 2: will compare the activity of NEURO SERUM against Placebo in a randomized cohort. The study is being carried out by the Oncoclinicas S.A. group, one of the largest networks of specialized cancer clinics in Brazil.

Type

SAFETY AND EFFICACY

N° of patients:

Part 1: 38 patients + Part 2: 60 patients

Status

ONGOING