MONTPELLIER, FRANCE – Sensorion, a pioneering clinical stage and gene therapy biotech company specializing in the development of novel therapies to treat, prevent and restore within the field of hearing loss disorders, announced its interim annual results as of June 30, 2020 alongside its outlook for 2020.
“Sensorion’s landmark gene therapy agreement with Institut Pasteur was a major inflection point in the company’s development. The positive preliminary preclinical data from the program targeting the OTOF gene reinforces the potential of this partnership, which expands our pipeline and supports our goal to become a leader in the field of hearing loss. The Phase 2 trial of SENS-401 in sudden sensorineural hearing loss is progressing and we expect results in mid-2021. We were delighted to successfully close an oversubscribed private placement in September, which raised €31 million. As part of this financing, we were pleased to see renewed support from existing shareholders such as Invus and Sofinnova Partners and to welcome new high-quality US and European investors. Following this financing, we estimate the cash in hand will carry us through to H2 2022”
–Nawal Ouzren, CEO of Sensorion
Key developments: Science and R&D
Collaboration with Institut Pasteur on gene therapy programs
In the second half of 2019, Sensorion launched two preclinical gene therapy programs targeting Usher Syndrome type 1 and Otoferlin deficiency, two monogenic forms of hereditary deafness. Under the framework agreement signed with Institut Pasteur in May 2019, other projects could also emerge in the area of genetic disorders of the inner ear. During the five years partnership agreement, Sensorion has preferred rights to the genetic disorders of the inner ear research pipeline of Institut Pasteur and the ability to implement collaborations leading to a license. These programs are conducted under the sponsorship of Professor Christine Petit, Director of the French Hearing Institute and Chair of our Scientific Advisory Board.
On June 9, 2020, Sensorion announced positive preliminary preclinical data from its gene therapy program targeting Otoferlin deficiency. In vivo experiments conducted in non-human primates (NHPs) show good safety and promising preliminary data on inner ear tissue tropism and the achievement of a high transduction rate efficiency.
Drug candidate SENS-401
The SENS-401 Phase 2 clinical trial in the treatment of sudden sensorineural hearing loss (SSNHL) in adults is a randomized, double-blind and placebo-controlled study, aiming to recruit ~260 patients. It is being conducted in 11 countries at approximately 30 sites in Europe and Canada.
On February 17, 2020, Sensorion received Ethics Committee approval to include new military sites in the SENS 401 Phase 2 study. The new centers will recruit volunteer military personnel exposed to extreme noise during their professional activities and suffering from hearing loss.
On March 13, 2020, Sensorion provided an update on the SENS-401 SSNHL Phase 2 AUDIBLE-S trial enrollment. Patient recruitment rates from this trial now indicate the data will be available by mid-year 2021, which is later than previously announced. An important factor resulting in delayed recruitment in the trial was the reallocation of emergency room resources due to the COVID-19 situation.
The independent Data Safety Monitoring Board (DSMB) undertook a review of the safety data for the patients included in the Phase 2 clinical trial on June 5, 2020. It confirmed the absence of any concern on the safety of SENS-401 and recommended continuing the trial as scheduled.
Following the agreement signed in December 2017, Sensorion and Cochlear (world leader in cochlear implants) have continued their collaboration. Thanks to its otoprotective properties demonstrated in several preclinical models, SENS-401 could potentially preserve residual hearing in patients with cochlear implants. Since 2018, we have successfully conducted additional safety studies to assess the feasibility of long-term treatment with SENS-401 that may be required in cochlear implant indications. Preclinical data from these studies are expected by the end of 2020.
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 modalities for drug candidates in the field of small molecules and gene therapy. This platform makes it possible to carry out a panel of investigations ranging from histology and cell culture (in vitro) to behavioral and electrophysiological tests (in vivo). The Company is also working on the identification of biomarkers to improve diagnosis and treatment of these illnesses with a high unmet medical need.
On January 30, 2020, Sensorion presented new SENS-401 preclinical data at the ARO (Association for Research in Otolaryngology) Mid-Winter Meeting 2020. A poster and oral presentation highlighted the potential to significantly reduce hearing loss from chronic noise exposure in a rat model. A second poster featured the age related hearing loss with significant early decline in functional auditory measures in Wistar rats.
Financial Position Strengthened by Capital Raise
Sensorion’s financial position strengthened further at the end of September 2020 following a €31M (~$36.5M USD) capital increase. The capital raise was achieved at a share price which was a 3.5% discount over the weighted average share price on the day preceding the date on which the issuance price was set (the “Reserved Offering”).
The completion of this capital increase was, amongst others, supported by existing shareholders, Invus Public Equities LP, Sofinnova Partners and WuXi AppTec.
The company intends to use the net proceeds from the Reserved Offering to develop its current gene therapy programs (OTOF and USHER), potentially broaden its gene therapy pipeline, support its pharmacology and clinical studies for the clinical development of SENS-401 and for general corporate purposes.
For additional details, view the company’s full report here.