A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed With Osteoarthritis of the Knee

The primary objective of this study is to evaluate the efficacy of a 14-day dosing regimen of ATB-346 at doses of 150 mg, 200 mg and 250 mg compared to placebo in reducing osteoarthritis knee pain as measured by changes in the post-treatment WOMAC subscale pain score relative to each patient's pretreatment baseline WOMAC assessment.Safety will be assessed via measurements of vital signs and clinical laboratory tests at baseline and at various time points during the study, patient monitoring, and by the documentation of adverse events.

Start Date29 Mar 2019

Sponsor / Collaborator

Antibe Therapeutics, Inc.

[+1]

NCT03291418 / CompletedPhase 1/2

A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects

Start Date08 Sep 2017

Sponsor / Collaborator

Antibe Therapeutics, Inc.

NCT03220633 / CompletedPhase 1

A Double-Blind, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability And Pharmacokinetics Of Single/Multiple Ascending Doses Of ATB-346 Orally Administrated In Healthy Male And Female Subjects

A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.

Start Date01 Jun 2014

Sponsor / Collaborator

Antibe Therapeutics, Inc.

[+1]

100 Clinical Results associated with ATB-346

100 Translational Medicine associated with ATB-346

100 Patents (Medical) associated with ATB-346

Literatures (Medical) associated with ATB-346

01 Apr 2021·Global spine journalQ3 · MEDICINE

Nonsteroidal Anti-Inflammatory Drugs and Their Neuroprotective Role After an Acute Spinal Cord Injury: A Systematic Review of Animal Models

Q3 · MEDICINE

ArticleOA

Author: Lambrechts, Mark J. ; Cook, James L.

Study Design::

Systematic review.

Objective::

Spinal cord injuries (SCIs) resulting in motor deficits can be devastating injuries resulting in millions of health care dollars spent per incident. Nonsteroidal anti-inflammatory drugs (NSAIDs) are a potential class of drugs that could improve motor function after an SCI. This systematic review utilizes PRISMA guidelines to evaluate the effectiveness of NSAIDs for SCI.

Methods::

PubMed/MEDLINE, CINAHL, PsycINFO, Embase, and Scopus were reviewed linking the keywords of “ibuprofen,” “meloxicam,” “naproxen,” “ketorolac,” “indomethacin,” “celecoxib,” “ATB-346,” “NSAID,” and “nonsteroidal anti-inflammatory drug” with “spinal.” Results were reviewed for relevance and included if they met inclusion criteria. The SYRCLE checklist was used to assess sources of bias.

Results::

A total of 2960 studies were identified in the PubMed/MEDLINE database using the above-mentioned search criteria. A total of 461 abstracts were reviewed in Scopus, 340 in CINAHL, 179 in PsycINFO, and 7632 in Embase. A total of 15 articles met the inclusion criteria.

Conclusions::

NSAIDs’ effectiveness after SCI is largely determined by its ability to inhibit Rho-A. NSAIDs are a promising therapeutic option in acute SCI patients because they appear to decrease cord edema and inflammation, increase axonal sprouting, and improve motor function with minimal side effects. Studies are limited by heterogeneity, small sample size, and the use of animal models, which might not replicate the therapeutic effects in humans. There are no published human studies evaluating the safety and efficacy of these drugs after a traumatic cord injury. There is a need for well-designed prospective studies evaluating ibuprofen or indomethacin after adult spinal cord injuries.

01 Feb 2020·British Journal of Pharmacology

A proof‐of‐concept, Phase 2 clinical trial of the gastrointestinal safety of a hydrogen sulfide‐releasing anti‐inflammatory drug

Article

Author: Buret, Andre G. ; Ditrói, Tamás ; de Nucci, Gilberto ; Wallace, John L. ; Vaughan, David J. ; Muscara, Marcelo N. ; Allain, Thibault ; Feener, Troy D. ; Nagy, Peter

Background and Purpose:

ATB‐346 is a hydrogen sulfide (H2S)‐releasing anti‐inflammatory and analgesic drug. Animal studies demonstrated negligible gastrointestinal (GI) damage despite marked inhibition of COX activity and significant analgesic and anti‐inflammatory effects. In humans, ATB‐346 (250 mg once daily) was found to inhibit COX to the same extent as naproxen (550 mg twice daily).

Experimental Approach:

Two hundred forty‐four healthy volunteers completed a 2‐week, double‐blind study, taking either ATB‐346 (250 mg once daily) or naproxen (550 mg twice daily), with upper GI ulceration being examined endoscopically.

Key Results:

Forty‐two per cent of the subjects taking naproxen developed at least one ulcer (≥3‐mm diameter), while only 3% of the subjects taking ATB‐346 developed at least one ulcer. The two drugs produced comparable and substantial (>94%) suppression of COX activity. Subjects in the naproxen group developed more ulcers per subject than ATB‐346‐treated subjects and a greater incidence of larger ulcers (≥5‐mm diameter). The incidence of dyspepsia, abdominal pain, gastro‐oesophageal reflux, and nausea was lower with ATB‐346 than with naproxen. Subjects treated with ATB‐346 had significantly higher plasma levels of H2S than those treated with naproxen.

Conclusions and Implications:

This Phase 2B study provides unequivocal evidence for a marked reduction of GI toxicity of the H2S‐releasing analgesic/anti‐inflammatory drug, ATB‐346, as compared to the conventional dose of naproxen that produced equivalent suppression of COX.

Linked Articles:

This article is part of a themed section on Hydrogen Sulfide in Biology & Medicine. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v177.4/issuetoc

01 Oct 2017·Journal of physiology and pharmacology : an official journal of the Polish Physiological Society

The effect of hydrogen sulfide-releasing naproxen (ATB-346) versus naproxen on formation of stress-induced gastric lesions, the regulation of systemic inflammation, hypoxia and alterations in gastric microcirculation.

Article

Author: Hubalewska-Mazgaj, M ; Kwiecien, S ; Magierowska, K ; Brzozowski, T ; Surmiak, M ; Magierowski, M ; Wallace, J L

Clinical use of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen is limited due to the gastrotoxicity evoked by these compounds. Endogenous hydrogen sulfide (H₂s) and delivered via an H₂s donor have been shown to play important role in the maintenance of gastric mucosal integrity. This study aimed to compare the effects of naproxen and an H₂s-releasing naproxen derivative (ATB-346) on gastric lesion induction by water immersion and restraint stress (WRS), the alterations in gastric blood flow (GBF) and the influence of these drugs on systemic inflammation. Wistar rats were pretreated i.g. with vehicle, naproxen (20 mg/kg) or ATB-346 (equimolar dose) or NaHS (5 mg/kg), the H₂s donor, combined with naproxen and exposed to 3.5 hours of WRS. The gastric lesion number and GBF were assessed by planimetry and laser Doppler flowmetry, respectively. Plasma concentrations of interleukins: IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α) and GM-CSF were determined by Luminex system and gastric mucosal protein expression of cystathionine-γ-lyase (CSE), cystathionine-β-synthase (CBS), 3-mercaptopyruvate sulfurtransferase (3-MST), nuclear factor (erythroid-derived 2)-like 2 (Nrf-2), hypoxia inducible factor-1α (HIF-1α), heme oxygenase-1 (HO-1) and cyclooxygenase (COX-2) were analyzed by Western blot. Pretreatment with naproxen increased the number of WRS stress-induced gastric lesions and significantly decreased GBF as compared with vehicle (p < 0.05). In contrast, pretreatment with ATB-346 or naproxen combined with NaHS significantly reduced WRS-lesions number and elevated GBF as compared with naproxen (p < 0.05). Naproxen significantly increased gastric mucosal protein expression of CSE, Nrf-2 and HIF-1α as compared with vehicle (p < 0.05), but failed to affect CBS, 3-MST and HO-1. ATB-346 significantly increased Nrf-2 and HO-1 protein expression as compared with vehicle (P < 0.05) but did not affect the protein expression of CSE, CBS, 3-MST or HIF-1α. ATB-346 but not naproxen decreased COX-2 protein expression in gastric mucosa compromised by WRS (p < 0.05). Exposure to WRS increased plasma concentration of all investigated cytokines (p < 0.05). ATB-346 but not naproxen decreased plasma content of IL-1α, IL-4, IL-5, IL-6, IL-10, IL-12, TNF-α and IFN-γ in rats exposed to WRS (p < 0.05). We conclude that H₂s through its vasoactive properties attenuates the gastrotoxic effects of naproxen, which increased stress-induced hypoxia in gastric mucosa. In contrast to naproxen, ATB-346 decreased stress-induced systemic inflammation and pro-inflammatory COX-2 expression in the gastric mucosa. The decreased gastrotoxicity of ATB-346 could be due to upregulation of Nrf-2/HO-1 pathway mediated by the release of H₂s.

News (Medical) associated with ATB-346

19 Apr 2024

·www.biospace.com

Antibe Provides Update on CCAA Proceedings

TORONTO--(BUSINESS WIRE)-- Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE) announced that the Company sought an extension of its previously announced stay of proceedings (“Stay”) under the Companies’ Creditors Arrangement Act (the “CCAA”) at a hearing before the Ontario Superior Court of Justice (Commercial List) (the “Court”) on April 18, 2024. The Court has reserved its decision and extended the Stay pending release of the decision. The Company is requesting to extend the Stay until May 24, 2024 in order to be able to continue engaging with the U.S. Food and Drug Administration with respect to the previously announced hold on the Company’s planned Phase II trial and to determine appropriate next steps. About Antibe Therapeutics Inc. Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is intended as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com. Forward Looking Statements This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the extension of the Stay, payment of amounts due to Nuance under the arbitral award, anticipated engagement with the U.S. Food and Drug Administration concerning the clinical hold on otenaproxesul. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the decision of the Court with respect to the extension of the Stay and any subsequent determinations made by the Court, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

Phase 2

16 Apr 2024

·www.biospace.com

Antibe Announces TSX Delisting Review

TORONTO--(BUSINESS WIRE)-- Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE) announced that the Toronto Stock Exchange (“TSX”) is reviewing the eligibility for continued listing on the TSX of the securities of the Company. The TSX has identified the Company’s financial condition as a criterion for delisting applicable to the Company. Antibe has been invited to make submissions to TSX and a hearing has been scheduled for the afternoon of April 23, 2024. Further updates will be provided as appropriate. The Company also confirms that it is no longer quoted on the OTCQX. About Antibe Therapeutics Inc. Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is intended as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com. Forward Looking Statements This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the TSX delisting review. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the decision of the TSX with respect to the delisting , the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law. View source version on businesswire.com: Contacts Antibe Therapeutics Inc. Christina Cameron VP Investor Relations +1 416-577-1443 christina@antibethera.com Source: Antibe Therapeutics Inc. View this news release online at:

09 Apr 2024

·www.biospace.com

Antibe to File an Application for an Initial Order Under Companies' Creditors Arrangement Act

TORONTO--(BUSINESS WIRE)-- Antibe Therapeutics Inc. (“Antibe” or the “Company”) (TSX: ATE, OTCQX: ATBPF) announced that it intends to application today with the Ontario Superior Court of Justice (Commercial List) (the "Court") for an Initial Order under the Companies' Creditors Arrangement Act (the "CCAA"). The application seeks an order that would, amongst other things, stay any action by Nuance Pharma to enforce the previously announced confidential ruling from the Singapore International Arbitration Centre requiring Antibe to pay approximately US$24 million to Nuance and would also enable the Company to continue engaging with the U.S. Food and Drug Administration with respect to the previously announced hold on the Company’s planned Phase II trial. In addition, the Company announced that Amal Khouri and Jennifer McNealey have resigned from its Board of Directors effective April 8, 2024. The Company thanks both Ms. Khouri and Ms. McNealey for their valuable contributions and wishes them well in their future endeavors. Additional Information Further updates will be provided as appropriate. About Antibe Therapeutics Inc. Antibe is a clinical-stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation therapies to target pain and inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs (“NSAIDs”). Antibe’s lead drug, otenaproxesul, is intended as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s next target is inflammatory bowel disease (“IBD”), a condition long in need of safer, more effective therapies. Learn more at antibethera.com. Forward Looking Statements This news release includes certain forward-looking statements under applicable securities laws, which may include, but are not limited to, statements concerning the application to the Court and the proposed terms of the Initial Order, payment of amounts due to Nuance under the arbitral award, anticipated engagement with the U.S. Food and Drug Administration concerning the clinical hold on otenaproxesul. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “will”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “propose” and similar wording. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the decision of the Court with respect to the Initial Order and any subsequent determinations made by the Court, the Company’s inability to timely execute on its business strategy and timely and successfully complete its clinical trials and studies, the Company’s inability to obtain the necessary regulatory approvals related to its activities, risks associated with drug development generally and those risk factors set forth in the Company’s public filings made in Canada and available on sedarplus.com. The Company assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

Phase 2Executive Change

100 Deals associated with ATB-346

External Link

KEGG	Wiki	ATC	Drug Bank
-	ATB-346	-	DB15377

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 2	CA	Antibe Therapeutics, Inc.	29 Mar 2019
Stomach Ulcer	Phase 2	CA	Antibe Therapeutics, Inc.	08 Sep 2017
Musculoskeletal Pain	Phase 2	CA	Antibe Therapeutics, Inc.	09 Mar 2016
Chronic Pain	Phase 1	CA	Antibe Therapeutics, Inc.	01 Jun 2014
Intestinal Neoplasms	Preclinical	CA	-	-
Melanoma	Preclinical	IT	University of the Philippines	-
Periodontal Diseases	Preclinical	CA	Antibe Therapeutics, Inc.	-

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