Trevena Inc. (NASDAQ:TRVN) has announced that its Chinese partner in the advancement of oliceridine has received approval from the National Medical Products Administration of China to commence IV oliceridine clinical trials.
Jiangsu Nhwa receives approval for oliceridine development and commercialization
Oliceridine is the lead investigational drug for Trevena that is meant to manage moderate to severe acute pain. The company’s Chinese partner, Jiangsu Nhwa, has a special license agreement for developing as well as commercializing oliceridine in the country.
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Carrie Bourdow, the CEO and president of Trevena, indicated that he was delighted to have reached such a significant regulatory breakthrough for oliceridine. He added that the company is now working towards its August 7 PDUFA timeline for possible US approval. Bourdow affirmed that Trevena was committed to supporting its ex-US collaborations as part of its goal of delivering proprietary treatment alternatives to moderate to severe acute pain patients. Trevena is expected to receive milestone payments in the future and around 10% royalty in oliceridine net sales in China.
Travene partners with Imperial College London on COVID-19 treatment
The company has also announced that it has signed a collaboration agreement with Imperial College London for the evaluation of TRV027 in the treatment of severe lung injury that results in ARDS in SARS-CoV-2 virus patients. Acute respiratory distress syndrome is considered one of the main complications that lead to COVID-19 related deaths. The study sponsors will be Imperial College London, with more support coming from the British Heath Foundation Centers for Research Excellence Award.
The company’s CEO indicated that this is a great opportunity to collaborate with Imperial College London in efforts to deliver a COVID-19 treatment to patients in need. Bourdow further indicated that their proprietary AT1 selective receptor agonist will offer a novel and innovative way of treating acute lung injury, which is a threat to COVID-19 patients.
TRV027, an investigational drug, studied in 691 patients, showed potency, selectivity, and efficacy in nonclinical studies. Equally, it has a well-categorized pharmacokinetic profile.