Development milestones for startups with Corona solutions

Solutions to curb the Corona virus come in different variations: for instance, Ender Diagnostic is developing rapid and reliable COVID-19 tests while Molecular Partners and Metriopharm are working on new therapies. Receiving the FDA clearance and progressing on clinical trials are the latest accomplishments made by the three startups.

Ender Diagnostics is based in Bern with a US subsidiary with offices in New Jersey and Miami. The startup is developing molecular diagnostic test kits for the rapid and reliable detection of SARS-CoV-2. Its testing kits, ender LAB and ender MASS, are in-vitro diagnostic test kits based on a rapid molecular isothermal nucleic acid amplification technology.

Ender LAB delivers results within 30 minutes after the extraction of the viral RNA, which makes it significantly faster than typically used PCR tests. It has a sensitivity of 97.7% and a specificity of 100%. ender LAB is the appropriate solution for a clinical set-up. The ender MASS does not require a conventional RNA extraction, saving hours of lab time and decreasing the use of consumables. It detects the SARS-CoV-2 virus within 30 minutes after sample preparation, making it the optimal laboratory-based solution for mass-testing in a public health set-up.

The two ender COVID-19 tests received the FDA notification, marking the entry of the Swiss company into the US market. With the continued surge of COVID-19 cases in the US, the American subsidiary of ender diagnostics, ENDER DIAGNOSTICS NORTH AMERICA, is ready to deliver rapid and reliable COVID-19 testing kits to diagnostic laboratories wishing to increase their testing capacities.

Molecular Partners doses the first patients
The clinical-stage biotech company is specialising in a new class of custom-built protein drugs known as DARPin therapeutics. As part of its anti-COVID-19 program, the company is developing MP0420 (ensovibep), a DARPin therapeutic candidate for the potential treatment and prevention of COVID-19. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. Pre-clinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy.

The company has dosed the first cohort of eight healthy volunteers in the first-in-human study of MP0420. Conducted in the United Kingdom, the study aims to evaluate the safety, tolerability, and pharmacokinetics of intravenously administered MP0420 in up to 24 healthy volunteers divided into three dose cohorts, with each cohort stratified 3:1 in favour of MP0420.

MetrioPharm prepares for Phase 2 clinical trials
Based in Zurich with research facilities in Berlin, MetrioPharm is a pharmaceutical company developing drugs for chronic inflammatory diseases such as psoriasis, arthritis, and multiple sclerosis. The company is preparing a Phase II clinical trial for its lead compound MP1032, battling COVID-19. Following positive data from pre-clinical studies, the company believes that MP1032 has the potential to both, slow down the spread of the virus in the body, and alleviate COVID-19 symptoms. MP1032 has also been clinically tested in a chronic inflammatory indication, and no adverse drug reactions were observed, when administered twice daily, for three months. This outcome underlines the excellent safety profile of MP1032. By conducting the Phase II clinical trial, MetrioPharm aims to demonstrate the efficacy of MP1032 in patients with COVID-19.