A Phase IIa, Multicenter, Randomized, Controlled, Open Label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity Induced by Cisplatin in Adult Subjects With a Neoplastic Disease

This study is intended to evaluate the ability of SENS-401 to prevent the ototoxicity induced by cisplatin in subjects with a neoplastic disease. It is a multicenter, randomized, controlled, two-arm, open-label efficacy and safety study in adults with neoplastic disease requiring treatment with cisplatin as part of the chemotherapy protocol plan.

Start Date30 Dec 2022

Sponsor / Collaborator

Sensorion SA

NCT05258773 / CompletedPhase 2

A Phase IIa, Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Presence of SENS-401 in the Perilymph After 7 Days of Repeated Oral Administration in Adult Participants Scheduled for Cochlear Implantation

The aim of this study is to detect the presence of SENS-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of SENS-401.

Start Date10 Aug 2022

Sponsor / Collaborator

Sensorion SA

100 Clinical Results associated with Azasetron besylate

100 Translational Medicine associated with Azasetron besylate

100 Patents (Medical) associated with Azasetron besylate

Literatures (Medical) associated with Azasetron besylate

26 Jun 2021·International Journal of Analytical ChemistryQ4 · CHEMISTRY

A Fast and Validated HPLC Method for the Simultaneous Analysis of Five 5-HT3 Receptor Antagonists via the Quantitative Analysis of Multicomponents by a Single Marker

Q4 · CHEMISTRY

ArticleOA

Author: Li, Peng ; Wang, Sicen ; Fang, Baoxia ; Chen, Fuchao

In this study, a new strategy for the simultaneous quantization of five serotonin 5-hydroxytryptamine receptor antagonists—ondansetron, azasetron, ramosetron, granisetron, and tropisetron—either in infusion samples or in injection dosage form was first established based on high-performance liquid chromatography combined with a quantitative analysis of multiple components by a single marker. The quantitative analysis of multicomponents by a single marker method was conducted with ondansetron as an internal reference substance and performed using relative retention time and ultraviolet spectral similarity as the double indicator. The quantitative analysis of the 5-HT3 receptor antagonists was calculated and investigated based on the relative correction factors. Chromatographic separation was achieved using a C18 column (150 mm × 4.6 mm, 5.0 μm), and the mobile phase was composed of acetonitrile-0.05 mol·L−1 potassium dihydrogen phosphate (pH 4.0) (25 : 75) at a flow rate of 1.0 mL·min−1 and detection wavelengths of 307 nm (ondansetron, azasetron, ramosetron), 302 nm (granisetron), and 285 nm (tropisetron). In addition, the accuracy of the quantitative analysis of multicomponents by a single marker method was compared with an external standard method, and no significant difference was observed between the two methods. The established method is rapid, is easy, and does not require many reference substances, and it can been successfully applied as part of the quality control of the five 5-HT3 receptor antagonists in their injection dosage form and infusion sample drugs in hospitals.

01 Aug 2019·Journal of Pharmaceutical SciencesQ3 · MEDICINE

Rat Kidney Slices for Evaluation of Apical Membrane Transporters in Proximal Tubular Cells

Q3 · MEDICINE

Article

Author: Nedachi, Shiho ; Nakanishi, Takeo ; Arakawa, Hiroshi ; Staub, Angelina Yukiko ; Tamai, Ikumi ; Kubo, Hikaru ; Ishiguro, Naoki ; Washio, Ikumi

Kidney slice has been often used as a tool reflecting basolateral transport in renal tubular epithelial cells. Recently, we reported that several important apical reabsorptive transporters such as Octn1/2, Sglt1/2, and Pept1/2 were functional in mouse kidney slices as well as transporter activities in basolateral side, which have been well accepted. Because rats are often used for preclinical pharmacodynamic and pharmacokinetic studies as well as mice, it is important to confirm applicability of rat kidney slices for evaluation of apically expressed transporters. The present study investigates usefulness of kidney slices from rats for evaluation of apical membrane transporters for efflux (multidrug resistance 1a, mdr1a) as well as influx (Octn1/2, Sglt1/2, Pept1/2). Na⁺-dependent uptake of ergothioneine (Octn1), carnitine (Octn2), and methyl-α-D-glucopyranoside (Sglt1/2) by rat kidney slices was observed, and the uptake was decreased by selective inhibitors. In addition, uptake of glycyl-sarcosine (Pept1/2) showed H⁺-dependence and was decreased by selective inhibitor. Furthermore, accumulation of mdr1a substrate azasetron was increased in the presence of zosuquidar, an mdr1a inhibitor, while strain differences existed. In conclusion, rat kidney slices should be useful for evaluation of renal drug disposition regulated by transporters in apical as well as basolateral membranes of rat renal proximal tubule cells.

01 Feb 2019·Otology & NeurotologyQ2 · MEDICINE

SENS-401 Effectively Reduces Severe Acoustic Trauma-Induced Hearing Loss in Male Rats With Twice Daily Administration Delayed up to 96 hours

Q2 · MEDICINE

Article

Author: Dyhrfjeld-Johnsen, Jonas ; Broussy, Audrey ; Poli, Sonia ; Van Ba, Christophe Tran ; Romanet, Charlotte ; Petremann, Mathieu

Hypothesis:SENS-401 (R-azasetron besylate) is effective against severe acoustic trauma-induced hearing loss.Background:SENS-401 has calcineurin inhibiting properties and attenuates cisplatin-induced hearing loss in a rat model. Cisplatin-induced and acoustic trauma-induced hearing loss share common apoptotic pathways.Methods:The dose–response relationship of SENS-401 (6.6 mg/kg BID, 13.2 mg/kg BID, 26.4 mg/kg QD) and treatment time-window (13.2 mg/kg BID starting 24, 72, and 96 h posttrauma) versus placebo for 28 days were evaluated in a male rat model of severe acoustic trauma-induced hearing loss (120 dB SPL, 2 h) using auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAE) measures followed by cochlear outer hair cell (OHC) counting with myosin-VIIa immunolabeling.Results:All SENS-401 doses improved ABR threshold shift and recovery, reaching statistical significance (p < 0.05) for ABR threshold recoveries after 28-days treatment. DPOAE amplitude loss and recovery improved markedly for 13.2 mg/kg BID SENS-401, reaching significance after 14 days (p < 0.05). Significant improvements in ABR threshold shifts/recovery and DPOAE amplitude loss occurred with up to 96-hours delay in initiating SENS-401 (p < 0.05), and in DPOAE amplitude recovery with up to 72-hours delay (p < 0.05). Significantly more surviving OHCs were present after SENS-401 treatment compared with placebo after 24 to 96-hours delay posttrauma, with up to 5.3-fold more cells in the basal cochlea turn.Conclusions:In vivo data support the otoprotective potential of twice daily oral SENS-401. Improvements in hearing loss recovery make SENS-401 a promising clinical candidate for acoustic trauma-induced hearing loss, including when treatment is not initiated immediately.

News (Medical) associated with Azasetron besylate

06 Nov 2024

·www.businesswire.com

Sensorion Announces Its Participation in Upcoming Investor Conferences to be Held in November 2024

MONTPELLIER, France--( BUSINESS WIRE )--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announced its participation in upcoming investor conferences to take place in November 2024. Sensorion will participate in the Stifel Healthcare Conference , which will be held in New York, USA, on November 18-19, 2024. Sensorion's management team will be present for one-to-one meetings on November 18, 2024. Sensorion will also participate in the LifeSci Capital and Sofinnova Partners Growth & Innovation Summit, to take place in London, UK, on November 18, 2024. Sensorion's management team will be present for one-to-one meetings throughout the conference. Sensorion will also be attending the Jefferies London Healthcare Conference, in London, UK, on November 19-21, 2024. Sensorion's management team will be present for one-to-one meetings throughout the conference. If you would like to meet Sensorion's management team, please contact us by email: ir.contact@sensorion-pharma.com About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, has completed in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. www.sensorion.com Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

Phase 2

26 Sep 2024

·www.businesswire.com

Sensorion Announces Webconference for Retail Shareholders on October 10, 2024

MONTPELLIER, France--( BUSINESS WIRE )--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces it is hosting a webconference for its retail shareholders on October 10, 2024. The webconference will be held in French. Sensorion’s Chief Executive Officer, Nawal Ouzren, and management team, will host a webconference dedicated to its retail shareholders, in French, on October 10, 2024, at 6pm CET (12pm ET), to comment on the Company’s latest announcements and outlook. Click here to join the meeting Meeting ID: 312 282 544 045 Secret Code: bfjH3J You will also be able to join the webconference from Sensorion’s website . About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT, in preclinical stage, targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, has completed in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. www.sensorion.com Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

Phase 2Gene Therapy

23 Sep 2024

·endpts.com

Context makes a T cell engager deal; Ginkgo Bioworks backers have a new SPAC

Plus, news about Longevity Biomedical, Sensorion, Teva and Bristol Myers Squibb: Context Therapeutics buys a T cell engager: The biotech will pay $15 million upfront and up to $118.5 million in biobucks for BioAtla’s Nectin-4 x CD3 T cell engager for solid tumors. Companies developing T cell engagers, or TCEs, have received more interest in recent months , particularly as they have started to test out the therapies in autoimmune diseases . — Kyle LaHucik Ginkgo Bioworks creators are back with another SPAC: The executives behind the blank check company that took Ginkgo Bioworks public have returned with plans for a new $250 million SPAC called Bold Eagle Acquisition. Ginkgo $DNA was valued at about $15 billion when it went public in September 2021. It’s now valued at $445 million. Bold Eagle’s leaders are serial SPAC creators and have been involved in several blank check combinations outside of biopharma including with Lionsgate Studios, Skillz, DraftKings and Target Hospitality. — Kyle LaHucik Longevity Biomedical also inks SPAC deal: The therapeutics and digital health company plans to combine with FutureTech II Acquisition and trade on the Nasdaq as $LBIO . Longevity’s pipeline includes a device for ischemic stroke, tissue biomaterial for soft-tissue reconstruction and other programs. — Kyle LaHucik Sensorion touts data from hearing loss pipeline: The French biotech said the first child given its gene therapy, SENS-501, in a Phase 1/2 trial tolerated the treatment well and had no adverse events. Meanwhile, data from a Phase 2 test of its small molecule drug, SENS-401, after seven weeks of treatment showed that 40% of patients had complete hearing preservation. — Ayisha Sharma Teva unveils Phase 3 schizophrenia results: The Tel Aviv-based company’s long-acting injectable, olanzapine, achieved “significant improvements” in the primary endpoint of the Positive and Negative Syndrome Scale (PANSS) total score at eight weeks. Teva is testing a subcutaneous form of its intramuscular injection. The safety profile was also consistent with oral formulations of olanzapine. — Ayisha Sharma Bristol Myers Squibb to lay off 79 workers in New Jersey: According to a Worker Adjustment and Retraining Notification notice , BMS plans to let go 79 employees in Lawrenceville, NJ, between December and January. BMS did not respond to a request for comment. The drugmaker has conducted several rounds of layoffs this year, including previous layoffs in Lawrenceville and letting go of 252 employees from a Mirati Therapeutics site in San Diego in March. — Katherine Lewin

Phase 2AcquisitionPhase 3Clinical ResultGene Therapy

100 Deals associated with Azasetron besylate

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hearing Loss, Sudden	Preclinical	GB	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	TR	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	SK	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	RS	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	DE	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	FR	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	BG	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	IL	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	CA	Sensorion SA	15 Feb 2019
Hearing Loss, Sudden	Preclinical	CZ	Sensorion SA	15 Feb 2019

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05628233 (BusinessWire) Manual	Phase 2	Ototoxicity	-	SENS-401	(gkcgjsycyp) = A good safety profile of SENS-401 is confirmed in the long term, with the drug being administered for the first time for an average duration of up to 23 weeks. wevsviiubd (fcmbzltglu )	Positive	20 Sep 2024
NCT05258773 (Corporate Publications) Manual	Phase 2	Hearing Loss	24	SENS-401 (Arazasetron)	(ewhejfdpxr) = zehmopkrzj vollsgzwyh (izznxhqnca )	Positive	15 Jul 2024
				Control group	(ewhejfdpxr) = ffsodddiyy vollsgzwyh (izznxhqnca )
NCT05258773 (Biospace) Manual	Phase 2	Hearing Loss	28	SENS-401	(urccgwfnok) = Presence of SENS-401 in the perilymph is confirmed in 100% of the patients sampled following cochlear implantation at levels compatible with potential therapeutic efficacy urdhsuqaor (xifrzlarov ) Met	Positive	11 Mar 2024
				non-treated arm
NCT03603314 (AUDIBLE-S, CTgov)	Phase 2/3	Hearing Loss, Sudden	115	SENS-401 (29 mg Dose Group)	buhodcszrf(yvwsehtlcw) = vwqonepjbe clhdqrvyqd (duzhlxgrnt, zbfmvhvozs - rufeelpgsr) View more	-	01 Mar 2023
				SENS-401 (43.5 mg Dose Group)	buhodcszrf(yvwsehtlcw) = gxqzfyzlmf clhdqrvyqd (duzhlxgrnt, sdloaqifhf - vdybnravnw) View more

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