Virpax Pharmaceuticals is planning to run three clinical trials of its drug candidates next year, with two studies set to start by mid-2024, said CEO Anthony Mack in an interview with Pharmaceutical Technology.

Berwyn, Pennsylvania-headquartered Virpax’s assets are built on two different drug delivery platforms. While a bupivacaine candidate uses Virpax’s liposomal encapsulation technology, the cannabidiol and enkephalin formulations are both based on the molecular envelope technology.

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Virpax is preparing for the start of a Phase II safety and efficacy trial of an injectable long-acting form of liposomal bupivacaine for post-operative pain management toward the end of H1 2024, said Mack. The company is developing the drug under the name Probudur and it is based on the company’s liposomal encapsulation delivery platform.

Since the company is pursuing an accelerated 505 (b) (2) new drug application for the drug, bupivacaine can be studied directly in the Phase II setting in patients after preclinical studies, explains Mack.

The Phase II trial will study the duration of bupivacaine effect as part of one of the endpoints, alongside its impact on the rate of morphine use, said Mack. The company hopes that bupivacaine will demonstrate little to no morphine use in the first 72 hours of the trial, he added.

The company is developing this bupivacaine formulation with the US Army, which is studying the drug’s use in battlefield wound injury, said Mack. According to him, this would eventually establish the drug’s use in two indications; with Virpax studying its use in post-operative pain management and the Army pursuing it for traumatic injuries. Virpax had entered into a cooperative research and development agreement with the US Army Institute of Surgical Research to study this bupivacaine formulation in May 2022.

Anthony Mack, CEO of Virpax Pharma

Virpax is also planning to start a Phase I safety trial of an enkephalin intranasal spray around mid-2024, said Mack.

Enkephalin is a peptide that targets delta receptor agonists within the brain that control severe pain, per the company’s website. The company is developing this intranasal formulation for severe cancer-related and non-cancer related pain under the name Envelta. Virpax expects to recruit between 20 and 30 subjects, noted Mack, adding that the total number would not be more than 50.

The company is also aiming to start a Phase I safety trial of its intranasal pharmaceutical-grade cannabidiol in H2 2024, said Mack. The company is developing the drug under the name NobrXiol as part of its intranasal molecular envelope technology.

In June 2023, Virpax entered into a cooperative research and development agreement with the National Institute of Neurological Disorders and Stroke (NINDS) for the further development of cannabidiol, per an announcement.