According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase 1 clinical trial of its ETH47 inhaled mRNA in healthy participants before the end of the year. The company is developing ETH47 as for the prevention and treatment and of viral respiratory infections, with delivery to the lung by either oral inhalation or nasal inhalation.
The announcement says that, “ETH47’s versatile, virus- and mutation-independent mode of action has the potential to broadly address seasonal and emerging respiratory virus infections including virus-driven exacerbation of chronic respiratory diseases such as asthma.” Ethris’s pipeline also includes inhaled therapies for the treatment of primary ciliary dyskinesia (PCD) and pulmonary alveolar proteinosis (PAP). At the end of 2022, Cipla announced that it was making a €15 million equity investment in Ethris.
Ethris CEO Carsten Rudolph commented, “Receiving regulatory clearance from UK’s MHRA for our inhaled mRNA-based drug candidate ETH47 and its imminent entry into the clinic marks a significant milestone for Ethris. The trial start will be our first program to enter the clinic and we look forward to this phase of ETH47’s development that brings us a step closer to providing innovative solutions that address the unmet need of respiratory viral infections, especially for the vulnerable population or patients with an underlying respiratory disease e.g., asthma or COPD.”
Read the Ethris press release.
