Delving into the Latest Updates on STR-324 with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Target

CD10

Action

inhibitors

Mechanism

enkephalinase inhibitors(Neprilysin inhibitors)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication-

Inactive Indication

Acute PainPainPain, Postoperative

Originator Organization

Chinese Academy of Sciences

Active Organization-

Inactive Organization

Stragen France SAS.

Chinese Academy of Sciences

Stragen Pharma SA

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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This study aims to evaluate the analgesic effect and the safety of 4 doses of STR-324 administered as an infusion, with or without initial bolus, to patients suffering from post-operative pain.
The sensitivity of the pain model used in the trial will be evaluated with a standard group treated with morphine under the usual care conditions.

Start Date01 Dec 2020

Sponsor / Collaborator

Alaxia SAS

NL-OMON46459

/ CompletedNot Applicable

A First-in-Human, randomized, double-blind, placebo-controlled ascending dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects. - First-In-Human PainCart study for STR-324

Start Date20 Feb 2018

Sponsor / Collaborator

Stragen France SAS.

NCT03430232

/ CompletedPhase 1

A First-in-Human, Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STR-324 in Healthy Subjects

This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.

Start Date20 Feb 2018

Sponsor / Collaborator

Stragen France SAS.

100 Clinical Results associated with STR-324

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100 Translational Medicine associated with STR-324

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100 Patents (Medical) associated with STR-324

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7

Literatures (Medical) associated with STR-324

01 Mar 2024·Anesthesiology

Influence of STR-324, a Dual Enkephalinase Inhibitor, on Postoperative Pain Scores: A Proof-of-Concept Trial in Patients after Laparoscopic Surgery

Article

Author: van der Wal, Imeen ; van Velzen, Monique ; Juarez-Perez, Victor ; van Dasselaar, Tom ; Sitbon, Philippe ; Dahan, Albert

This article describes the STR-324, dual enkephalinase inhibitor, on postoperative pain scores and it proof-of concept trial in patients after laparoscopic surgery.STR-324, a chem. stable analog of opiorphin, is a dual enkephalinase inhibitor that enhances the activity of endogenous enkephalins by inhibiting their degradationUnlike traditional opioids, STR-324 targets the δ-opioid receptor, offering potential advantages such as reduced dependency and absence of respiratory depression.To evaluate the efficacy and safety of STR-324 in managing postoperative pain in patients undergoing laparoscopic abdominal or pelvic surgery.In this double-blind, randomized exploratory trial, 81 patients received escalating doses of STR-324 via a 20-min infusion, while 26 patients received morphine as a comparator.The primary endpoint was the proportion of responders, defined as patients achieving a reduction in pain intensity by ≥2 points on an 11-point Numerical Rating Scale (NRS) or reaching an NRS score of ≤3 during the infusion period.Secondary endpoints included maximum decrease in pain intensity and safety evaluation.The maximum NRS reduction was 0.9 ± 1.3 for STR-324 and 1.0 ± 1.2 for morphine (P = 0.65). No safety concerns or adverse effects were observed in either group.The time to switch to standard pain management was similar between groups.STR-324 demonstrated promising analgesic effects in postoperative pain management, with no safety concerns.By enhancing endogenous opioid activity, STR-324 offers a novel, potentially safer alternative for treating moderate to severe pain.Further studies are warranted to confirm its efficacy and explore optimal dosing strategies.

01 Jan 2024·Current Topics in Medicinal Chemistry

Enhancing Opiorphin’s Metabolic Stability and Preserving its Potent Analgesic Effect: A Systematic Review

Review

Author: Ibrahim, Mohammed Nurudeen ; Cowan, Logan Thomas ; Tome, Joana

Background:Opiorphin has been reported to show a stronger analgesic effect than morphine without causing side effects brought about by morphine-like drugs. Functional opiorp-hin analogs have been created to enhance its metabolic stability and preserve its potent analgesic effect.Objective:We conducted a systematic review to summarize all opiorphin analogs and identify those with the strongest metabolic stability and antinociceptive effect.Methods:From a total of 122 articles, 11 made it to the quantitative synthesis phase. The included articles were categorized into the type of modifications used to improve the metabolic stability of the peptide, metabolism and toxicity profile, drug absorption and in vitro cytotoxicity, anti-nociceptive effect, the opiorphin analogs’ administration in animals or humans, and the type of the test used to test the antinociceptive effect.Results:The substitution of natural amino acid with a non-natural amino acid, side-chain modifications, or D-aminoacid substitution were the most used type of peptide modification to create opiorphin analogs. STR-324 and PEGylated liposomes loaded with opiorphin showed the best metabolism and toxicity performance. [C]-[(CH2)6]-QRF-[S-O-(CH2)8]-R showed high stability in human plasma and stronger inhibitory potency. YQRFSR and PEGylated liposomes loaded with opiorphin showed a stronger antinociceptive effect than the parent opiorphin or morphine, with an analgesic effect of PEGylated liposomes lasting more than 50%. Intravenous administration was the preferred method of opiorphin analog administration, and different tests were used to test the antinociceptive effect.Conclusion:This paper presents the first systematic review discussing opiorphin and opiorphin analogs and identifies the most promising candidates for future research.

01 Jan 2022·British Journal of Clinical PharmacologyQ2 · MEDICINE

First‐in‐human trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR‐324, a dual enkephalinase inhibitor for pain management

Q2 · MEDICINE

Article

Author: Juarez‐Perez, Victor ; Moss, Laurence M. ; Kamerling, Ingrid M. C. ; Groeneveld, Geert Jan ; Bergmann, Kirsten ; van Brummelen, Emilie M. J. ; Klaassen, Erica S. ; Benichou, Annie‐Claude ; Berends, Cecile L. ; Ville, Vanessa

AimDual enkephalinase inhibitors (DENKIs) are involved in the regulation of nociception via opioid receptors. The novel compound STR‐324 belongs to the DENKI pharmacological class. This first‐in‐human study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of STR‐324 in healthy male participants.MethodsThis was a randomised, double‐blind, placebo‐controlled ascending dosing study in two parts: in part 1, 30 participants received 0.004‐11.475 mg h−1 of STR‐324 or placebo (ratio 4:1) by 4 h intravenous infusion in a two‐group, partial crossover design with four treatment periods separated by 1 month wash‐out, and in part 2, 48 participants divided into three groups received either the active drug (1.25‐11.25 mg h−1) or placebo (ratio 3:1) by 48 h intravenous infusion. Safety and tolerability parameters, pharmacokinetics and pharmacodynamic effects on neurocognitive and neurophysiological tasks and on a nociceptive test battery were evaluated.ResultsNo clinically relevant changes in safety parameters were observed. All treatment‐emergent adverse events were mild and transient. The pharmacokinetics of STR‐324 could not be determined due to most concentrations being below quantifiable limits. STR‐324 metabolite concentrations were measurable, showing dose proportionality of Cmax and AUCinf with an estimated t1/2 of 0.2‐0.5 h. Significant changes in pharmacodynamic parameters were observed, but these were not consistent or dose‐dependent.ConclusionSTR‐324 displayed favourable safety and tolerability profiles at all doses up to 11.475 mg h−1. Although pharmacokinetic characterisation of STR‐324 was limited, dose proportionality could be assumed based on major metabolite data assayed as proxy. No clear effects on nociceptive thresholds or other pharmacodynamic measures were observed.Trial registry: EudraCT (2014‐002402‐21) and toetsingonline.nl (63085).

100 Deals associated with STR-324

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 2	Netherlands	Stragen France SAS.	01 Dec 2020
Pain, Postoperative	Phase 2	Netherlands	Stragen Pharma SA	08 Nov 2020
Pain	Phase 2	-	Stragen Pharma SA	-
Pain	Phase 2	-	Chinese Academy of Sciences	-

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