MONTPELLIER, FRANCE — Sensorion, a biotechnology company dedicated to improving the lives of people with hearing disorders, has recently released its first-half results for 2023, and the reports the outlook for the remainder of the year looks promising.
- Major Milestones Achieved: Sensorion made significant progress in its mission to develop therapies for hearing loss disorders. One of the highlights is the submission of Clinical Trial Applications (CTAs) in the UK and Europe for the SENS-501 (OTOF-GT) program. This gene therapy program aims to restore hearing in patients with OTOF gene mutations, a common cause of congenital hearing loss.
- Positive Clinical Trial Results: Sensorion also reported positive preliminary results from a Phase 2a clinical trial of SENS-401. This drug is designed to prevent residual hearing loss in individuals who have received cochlear implants, a common treatment for hearing loss.
- Financial Boost: The company successfully completed a private placement, raising €35 million, led by Redmile Group, a US-based healthcare investor. This funding, along with continued support from existing shareholders, will extend Sensorion’s financial runway until the end of September 2024.
Nawal Ouzren, CEO of Sensorion, expressed optimism about the company’s progress. She emphasized their commitment to developing solutions for patients with hearing disorders, acknowledging the challenges faced in the market and the importance of securing international investments with expertise in gene therapy. Ouzren also thanked shareholders for their support and loyalty.
“Over the past few months, Sensorion has achieved several decisive milestones on its roadmap to develop solutions that will potentially improve the quality of life of patients suffering from hearing disorders. In August, in a difficult market environment, we succeeded in closing a major round of financing from international investors with unique gene therapy expertise. This deal strengthens our financial visibility and our stable, committed, and ambitious shareholder base. At the same time, we have made significant regulatory and operational progress with our most innovative programs, in particular SENS-501. We are positioned to bring our first gene therapy drug candidate into the clinic by mid-2024 and to reaffirm our ambition to rank among the leaders in a field which holds immense promise for patients suffering from genetic hearing loss, and which is attracting growing interest from the pharmaceutical industry. In parallel, building on the very promising clinical results unveiled in July, we are confidently pursuing the clinical development of SENS-401, with the support of our Australian partner Cochlear Limited. As we enter an extremely exciting period for Sensorion, I would like to thank all our shareholders, both individual and institutional, for their support and loyalty.”
Sensorion continued to advance its gene therapy programs, particularly SENS-501 (OTOF-GT), which aims to restore hearing in patients with OTOF gene mutations. This program has received Orphan Drug Designation from regulatory agencies in the US and Europe, supporting its development.
The company is also working on SENS-401, a drug designed to protect inner ear tissue. Preliminary results from a Phase 2a clinical trial showed promising outcomes, with patients who received SENS-401 experiencing significantly less hearing loss following cochlear implantation compared to a control group.
Sensorion outlined several upcoming milestones, including the expected approval of the first Clinical Trial Application for SENS-501 (OTOF-GT) by the end of 2023 and the inclusion of the first patient in H1 2024. They also anticipate final data from the SENS-401 clinical trial in H1 2024.
The company’s financial position as of June 30, 2023, showed Cash & Cash Equivalents of €14.4 million. Research and Development expenses increased slightly due to the focus on gene therapy programs. General and Administrative expenses decreased compared to the previous year. The net loss for H1 2023 remained consistent with H1 2022.
Based on their financial forecasts and the recent private placement, Sensorion expects to fund its operations until the end of Q3 2024.
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. OTOF-GT 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, 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.