Cochlea

Sensorion Announces the Completion of Patient Inclusion in Phase 2a Clinical Trial of SENS-401 for Residual Hearing Preservation After Cochlear Implantation

Retrieved on: 
Thursday, February 1, 2024

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 the recruitment of the last patient in its Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation.

Key Points: 
  • 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 the recruitment of the last patient in its Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation.
  • Patients start treatment with SENS-401 7 days before implantation and continue to receive SENS-401 for a further 42 days.
  • The study has been developed with Sensorion’s partner, Cochlear Limited, the global leader in implantable hearing devices.
  • The first preliminary efficacy data from this clinical trial were very promising and reinforce our confidence in the potential of SENS-401 in hearing loss prevention."

Sensorion Announces Approval to Initiate Lead Gene Therapy Candidate SENS-501 (OTOF-GT) into a Phase 1/2 Clinical Trial in some European Countries

Retrieved on: 
Friday, January 19, 2024

Audiogene will also assess the clinical safety, performance, and usability of the administration device system under development in partnership with EVEON.

Key Points: 
  • Audiogene will also assess the clinical safety, performance, and usability of the administration device system under development in partnership with EVEON.
  • The design of the study will consist of two cohorts of 2 doses followed by an expansion cohort at the selected dose.
  • The CTA approval follows extensive preclinical studies assessing the safety and efficacy of SENS-501 and successful manufacturing of the gene therapy Drug Product for the clinical trial.
  • Sensorion presented preclinical data that indicated the potential for safe and efficient clinical translation of gene therapy for otoferlin delivered by a dual AAV vector.

Acousia Therapeutics attracts new investor on its path to make hearing loss a treatable disease

Retrieved on: 
Tuesday, January 9, 2024

The infusion of fresh capital is set to boost the progress of Acousia's Kv7.4 activator programs, with a focus on advancing the ongoing clinical development of ACOU085.

Key Points: 
  • The infusion of fresh capital is set to boost the progress of Acousia's Kv7.4 activator programs, with a focus on advancing the ongoing clinical development of ACOU085.
  • ACOU085 is a proprietary, small-molecule, etiology-agnostic otoprotective drug candidate, which recently entered Phase 2 clinical testing for the prevention of chemotherapy-induced hearing loss and sensory hair cell death in cancer patients.
  • The significant otoprotective potential of ACOU085 is broadly supported by results from a number of preclinical studies in relevant models.
  • Our lead candidate ACOU085, currently in Clinical Phase 2, aims to set a new standard for treating acute and subacute forms of hearing loss."

Acousia Therapeutics attracts new investor on its path to make hearing loss a treatable disease

Retrieved on: 
Tuesday, January 9, 2024

The infusion of fresh capital is set to boost the progress of Acousia's Kv7.4 activator programs, with a focus on advancing the ongoing clinical development of ACOU085.

Key Points: 
  • The infusion of fresh capital is set to boost the progress of Acousia's Kv7.4 activator programs, with a focus on advancing the ongoing clinical development of ACOU085.
  • ACOU085 is a proprietary, small-molecule, etiology-agnostic otoprotective drug candidate, which recently entered Phase 2 clinical testing for the prevention of chemotherapy-induced hearing loss and sensory hair cell death in cancer patients.
  • The significant otoprotective potential of ACOU085 is broadly supported by results from a number of preclinical studies in relevant models.
  • Our lead candidate ACOU085, currently in Clinical Phase 2, aims to set a new standard for treating acute and subacute forms of hearing loss."

Merck Manuals Details Different Types of Ear Infections

Retrieved on: 
Tuesday, October 3, 2023

RAHWAY, N.J., Oct. 3, 2023 /PRNewswire/ -- Most of us can remember the intense pain and bubble gum-flavored medicine that accompanied ear infections as kids. But not all ear infections are the same, and understanding the differences can be key to effective diagnosis and treatment.

Key Points: 
  • In a new editorial from MerckManuals.com, Bradley W. Kesser, MD, University of Virginia School of Medicine, details the different parts of the ear and how infections in each area differ.
  • The ear is made up of three parts – the external ( outer ear ), middle ear , and internal ( inner ear ).
  • Infections in the canal portion of the outer ear are often referred to as swimmer's ear .
  • For outer ear infections, a thorough cleaning of the ear along with a topical antibiotic applied directly to the outer ear is typically recommended.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Retrieved on: 
Wednesday, September 27, 2023

STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Key Points: 
  • STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.
  • Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023.
  • "We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products," said CEO Renée Aguiar-Lucander.
  • Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Retrieved on: 
Wednesday, September 27, 2023

STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Key Points: 
  • STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.
  • Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023.
  • "We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products," said CEO Renée Aguiar-Lucander.
  • Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen.

Sensorion Reports 2023 First Half Results

Retrieved on: 
Wednesday, September 20, 2023

In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.

Key Points: 
  • In the first half of 2023, Sensorion achieved a major development milestone by completing the preclinical package, and successfully producing the GMP dual AAV OTOF-GT batches at 200L clinical scale.
  • In April 2023, Sensorion announced the candidate selection for GJB2-GT during its R&D Day focusing on gene therapy.
  • The first patient was enrolled in December 2022 and Sensorion anticipates the publication of the preliminary results in H2 2023.
  • The annual accounts on June 30, 2023, drawn up according to IFRS standards and approved by the Board of Directors on September 18, 2023.

Hearing loss company Acousia Therapeutics to present key learnings and data from lead development programs at US and European meetings in August and September

Retrieved on: 
Wednesday, August 23, 2023

From August 29–31, Acousia Therapeutics has been invited to contribute two presentations at the 3rd Annual Inner Ear Disorders Therapeutics Summit in Boston (MA).

Key Points: 
  • From August 29–31, Acousia Therapeutics has been invited to contribute two presentations at the 3rd Annual Inner Ear Disorders Therapeutics Summit in Boston (MA).
  • Dr. Jonas Dyhrfjeld-Johnsen, Chief Development Officer of Acousia Therapeutics, will also participate in the panel discussion "Understanding how the Differences in Chosen Animal Model and Human Hearing Development Impacts Preclinical Efficacy and Translational Success".
  • It recently completed a successful first-in-man clinical Phase 1b study using the standard transtympanic administration of a slow-release gel formulation.
  • It has the potential to both acutely enhance natural hearing and preserve hearing capacity for people with chronic, progressive disorders like e.g.

Hearing loss company Acousia Therapeutics to present key learnings and data from lead development programs at US and European meetings in August and September

Retrieved on: 
Wednesday, August 23, 2023

From August 29–31, Acousia Therapeutics has been invited to contribute two presentations at the 3rd Annual Inner Ear Disorders Therapeutics Summit in Boston (MA).

Key Points: 
  • From August 29–31, Acousia Therapeutics has been invited to contribute two presentations at the 3rd Annual Inner Ear Disorders Therapeutics Summit in Boston (MA).
  • Dr. Jonas Dyhrfjeld-Johnsen, Chief Development Officer of Acousia Therapeutics, will also participate in the panel discussion "Understanding how the Differences in Chosen Animal Model and Human Hearing Development Impacts Preclinical Efficacy and Translational Success".
  • It recently completed a successful first-in-man clinical Phase 1b study using the standard transtympanic administration of a slow-release gel formulation.
  • It has the potential to both acutely enhance natural hearing and preserve hearing capacity for people with chronic, progressive disorders like e.g.