Two Swiss biotech companies report results of Phase II clinical trials

EsoCap AG, the Swiss biotech company dedicated to improving the lives of patients with serious diseases of the upper gastrointestinal tract, announced today that the complete results of the ACESO Phase II study evaluating ESO-101 for the treatment of eosinophilic esophagitis have been published in Alimentary Pharmacology & Therapeutics. The data demonstrate that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in adults with active eosinophilic esophagitis (EoE). EoE is a chronic, local, immune-mediated esophageal disease characterized clinically by symptoms associated with esophageal dysfunction, including dysphagia (i.e., swallowing difficulties), food impaction, heartburn and vomiting, and histologically by eosinophil-dominated inflammation.

The ACESO trial met its primary endpoint with a statistically significant reduction of the peak eosinophil count from baseline in histology samples. Patients treated with ESO-101 had a significant response in the eosinophilic esophagitis endoscopic reference score (EREFS) scores, indicating promising potential for remodeling effects despite the short treatment duration.

A significant improvement of dysphagia symptoms was observed after a 4-week period with a high placebo response: a benefit of ESO-101 in relieving EoE dysphagia and odynophagia symptoms is expected to be seen in future clinical trials with a longer treatment period.

Importantly, ESO-101 also demonstrated a highly favorable safety and tolerability profile with a notable absence of oral and oropharyngeal aswell as esophageal candidiasis, which is commonly observed with topical corticosteroid treatment. Compliance was high, with 100% in the ESO-101 and 93% in the placebo groups. The high level of patient satisfaction with the handling of the study medication underlines the user-friendliness of the ESO-101 drug-delivery system.

The EsoCap system is a unique drug delivery system for the upper gastrointestinal tract, consisting of a capsule holder containing a hard gelatin capsule, with a rolled, thin mucoadhesive film, a sinker, and a soluble retainer. The capsule holder is screwed onto the lid of a drinking cup to facilitate swallowing while drinking from the cup. Upon swallowing, the film unrolls and sticks to the esophageal mucosa, where it dissolves, with a contact time of 15 minutes, significantly longer than the mucosal contact time of pharmaceutical dosage forms, such as orodispersible tablets (less than one minute).

NovaGo reports about results for NG101 in acute spinal cord injury patients

NovaGo Therapeutics AG, a clinical stage biotech company focused on advancing therapeutics for patients with spinal cord injury or diabetic retinopathy, announced recently that its academic collaboration partners the Nogo-A Inhibition in Spinal Cord Injury Study Group (NISCI) published the results for the investigation of NG101 in acute spinal cord injury patients in Lancet Neurology.

The NISCI phase 2 study evaluated the efficacy and safety of an anti-Nogo-A antibody in 129 acute spinal cord injury patients in a multicenter and multi country placebo controlled clinical trial (NCT03935321).

According to the publication in Lancet Neurology the primary and most secondary endpoints were not met in the overall cohort. Although the primary outcome of upper extremity motor score (UEMS) did not show a significant difference overall, the trial provided evidence of improvement in a secondary outcome, Spinal Cord Independence Measure (SCIM) of self-care, in the NG101-treated group. 

A post-hoc analysis in a group of patients with motor-incomplete spinal cord injury suggested better UEMS recovery in motor-incomplete patients with cervical spinal cord injury treated with NG101 than in those who received placebo. This UEMS improvement in NG101-treated participants with motor-incomplete spinal cord injury might have contributed to increased functional independence, resulting in higher gains in activities of daily living (SCIM self-care), a key goal for patients with cervical spinal cord injury and their caregivers.

Treatment proved feasible and was well tolerated in this vulnerable and complex patient population.

“We are excited to see early signs of disease modifying effects for the treatment of acute spinal cord injuries and applaud the team for their remarkable achievements.” said Stefan Moese, CEO of Novago. “The NISCI Phase 2a study is the first of its kind designed to demonstrate that anti-Nogo-A treatment can enhance the quality of life for patients with acute spinal cord injuries. We extend our heartfelt gratitude to the NISCI team, the clinical investigators, and the study participants for their invaluable contributions and unwavering commitment to this program,” said Prof. Martin Schwab, CSO of Novago and initiator of the NISCI consortium.

Novago started the clinical development of a new and improved anti-Nogo-A antibody NG004, more details will follow soon.