Shanghai, September 11, 2024 — SIMR Biotech is pleased to announce that the first patient has been successfully enrolled in its multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating SR1375 in hospitalized pneumonia patients on oxygen therapy. This trial marks a significant milestone in the development of SR1375 and underscores SIMR’s commitment to addressing the unmet medical needs in pneumonia treatment.

The Phase 2 study will evaluate the efficacy and safety of multiple doses of SR1375 in patients with moderate-to-severe pneumonia, a condition associated with high mortality rates, particularly among aging populations, patients with multimorbidity status, and those with compromised immune systems. The trial will focus on clinical outcomes such as improvements in clinical status, pulmonary function, imaging results, and mortality rates, as well as the drug's safety profile.

About SR1375

SR1375 is a first-in-class, oral small molecule drug designed to alleviate the progression of acute and chronic inflammation-related diseases. The leading indication is for hospitalized pneumonia patients on oxygen therapy. Two phase 1 studies of SR1375 have been successfully completed in healthy volunteers in China and Australia, demonstrating good safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics.

In 2023, an investigator-initiated Phase 1b clinical trial was completed in hospitalized pneumonia patients, demonstrating the safety and preliminary efficacy of SR1375. These promising results further support the continued clinical exploration of SR1375 as a potential complementary therapy in the treatment of pneumonia.

SIMR Biotech was the first to discover and validate the function of SR1375 in pneumonia. Preclinical data showed that SR1375 has multiple mechanisms of action, including anti-inflammatory, vascular-protective, and improvements in lung tissue pathology, which are critical in managing pneumonia and reducing disease progression.

Patents for SR1375 have been filed in over 20 countries, including the United States, Europe, Japan, Australia, and key emerging pharmaceutical markets such as Brazil and India.

Pneumonia: A Growing Unmet Medical Need

Pneumonia remains a significant health challenge worldwide, with rising mortality rates, especially among the elderly with multimorbidity status. Current treatments often fall short, highlighting the urgent need for new therapies. SR1375 is expected to fill this gap by providing a novel therapeutic option for pneumonia patients requiring oxygen therapy.

Next Steps

Following the successful dosing of the first patient, SIMR Biotech is focused on advancing SR1375 through the clinical development pathway. The company aims to complete trial enrollment and reach further regulatory milestones, potentially bringing SR1375 to market as a breakthrough therapy for pneumonia patients globally.