BERWYN, Pa. - Virpax Pharmaceuticals Inc. (NASDAQ: VRPX) has announced favorable outcomes from a Maximum Tolerated Dose (MTD) study for its drug Probudur, a non-addictive pain management product.
The study, conducted on Sprague-Dawley rats, aimed to evaluate the safety and efficacy of the injectable liposomal bupivacaine formulation designed to offer both immediate and sustained post-surgical pain relief.
Probudur is at the core of Virpax's efforts to minimize the necessity for opioids after surgery. The preclinical trials indicated that the drug could control pain for a period extending up to 96 hours, with further in vitro studies showing a slow release of the active ingredient lasting up to six days. The MTD study's results suggest that the drug is well-tolerated, with no significant effects on body weight, clinical chemistry, hematology, or coagulation observed.
The histopathological examination of the injection sites revealed minimal to moderate changes, which were slightly more pronounced at higher doses of Probudur. However, the in vivo MTD studies in rats demonstrated a better therapeutic window for Probudur compared to free bupivacaine.
According to Virpax CEO Gerald Bruce, these findings reinforce the company's confidence in the drug's potential to provide both immediate and extended pain relief after a single injection. Bruce also noted that the proprietary formulation of Probudur eliminates the need for simultaneous administration of free bupivacaine.
Virpax is advancing towards completing the required preclinical studies and plans to file an Investigational New Drug Application (IND) for Probudur by the end of the year. The company is also developing other non-addictive pain management products, including Envelta for acute and chronic pain and NobrXiol for rare pediatric epilepsy.
This announcement is based on a press release statement by Virpax Pharmaceuticals and contains forward-looking statements regarding the drug's potential and the company's plans for regulatory approval.
InvestingPro Insights
As Virpax Pharmaceuticals (NASDAQ: VRPX) continues to make headway with its innovative pain management solutions, the financial landscape presents a mixed picture. The company holds more cash than debt, which can be an indicator of financial stability and may provide some cushion as it navigates the path towards regulatory approval for Probudur. This is a crucial aspect for investors to consider, given the company's stage in the drug development process.
However, it's important to note that Virpax's stock has faced significant pressure recently, with a 12.34% drop in the last week and a 34.99% decrease over the past month. These figures underscore the volatility inherent in the biotech sector, especially for companies in the drug development stage without revenue-generating products.
The market cap of Virpax is currently at 3.24M USD, reflecting the market's assessment of the company's value based on its current and potential future performance. With a negative P/E ratio (adjusted) of -0.25 for the last twelve months as of Q4 2023, Virpax is not yet profitable, which is not uncommon for biotech firms at this stage of development. The company's focus now is likely on advancing its clinical programs to achieve regulatory milestones that could potentially enhance its financial metrics.
For investors seeking comprehensive analysis and additional insights on Virpax Pharmaceuticals, InvestingPro offers a full suite of tips and metrics. There are currently 7 additional InvestingPro Tips available, which can help investors make more informed decisions. To explore these tips and to take advantage of an exclusive offer, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at https://www.investing.com/pro/VRPX.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.