Petrovax: Longidase (bovgialuronidase azoximer)

The main articles are:

• Coronavirus COVID-19
• Postcoid syndrome

2024: Results of the "Long-CoV-III-21" study

Petrovax announced positive results from the Long-CoV-III-21 study, a randomized, double-blind, placebo-controlled study of the efficacy and safety of azoximer bovgialuronidase in adult patients with postcovid pulmonary sequelae. Bovgialuronidase azoximer, available under the trade name Longidase, is a conjugated polymer hyaluronidase with an increased half-life. Study drug and placebo were administered for 71 days and the follow-up period lasted up to 180 days. The company announced this on December 18, 2024.

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Petrovax

Longidase demonstrated a statistically significant reduction of 62% in the proportion of patients with load desaturation (OR=0.35, p=0.0051) and 27% in the proportion of patients with load dyspnea (OR=0.62, p=0.043) on Day 71 compared with placebo. Marked improvement was also observed with respect to breathlessness at rest and during the six-minute walking test. The effect of drug administration on exercise tolerance was maintained for more than 100 days after the last dose.

Longidase did not affect lung function in the general population. However, subgroup analyses showed that the drug was associated with a significantly greater change in predicted forced vital capacity (FVC) from baseline in patients with concomitant cardiovascular disease (difference=3.31%, p=0.042) and in those infected with earlier SARS-CoV-2 variants (difference=4.17%, p=0.021) compared with placebo.

Long-CoV-III-21 is one of the first randomized double-blind trials to show a significant effect of the new therapy in patients with pulmonary sequelae of COVID. The long-term effect of Longidase gives hope for improving the quality of life for patients suffering from shortness of breath, fatigue and reduced physical performance, - said Sergey Avdeev, Doctor of Medical Sciences, Head of the Department of Pulmonology, Sechenov University and Head of the Study. - Despite the fact that the drug did not significantly affect the restoration of pulmonary function in the entire population, the results in subgroups strongly suggest the need to continue studies of hyaluronidase-based drugs - not only for the treatment of postcoid pulmonary consequences, but also for other fibrotic conditions.

In parallel with the study of the use of the drug after a previous coronavirus infection, Petrovax is developing an inhalation form of Longidase for the treatment of interstitial lung diseases. The safety of this mode of delivery was demonstrated in a recent Phase 1 study. A Phase 2 study of the inhaled form of Longidase in patients with idiopathic pulmonary fibrosis is planned for 2025.