CRANBURY, N.J. - Palatin Technologies (NYSE:PTN), Inc. (NYSE American: PTN), a biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 clinical study of bremelanotide, in combination with tirzepatide, for obesity treatment. The trial is set to commence mid-2024, aiming to enroll up to 60 patients across approximately five U.S. sites.
The study will evaluate the safety and efficacy of the co-administration of bremelanotide, a melanocortin receptor 4 agonist (MCR4), with tirzepatide, currently a standard of care for obesity.
The primary goal is to demonstrate enhanced effectiveness and safety in weight reduction. Participants will initially receive tirzepatide alone for four weeks before being randomized into one of four treatment regimens, with topline data anticipated by the end of 2024.
Palatin's President and CEO, Carl Spana, Ph.D., highlighted the potential benefits of combining an MCR4 agonist with incretin therapeutics for obesity treatment, citing the possibility of synergistic effects that could lead to greater weight loss at lower, more tolerable doses. The company has a history of obesity research and holds a portfolio of novel selective MCR4 agonists.
The announcement also mentions a virtual Key Opinion Leader (KOL) event scheduled for May 8, 2024, to discuss the company's metabolic program and the role of novel MCR4 agonists in treating obesity and maintaining weight loss. Jesse Richards, DO, from the Oklahoma State University College of Osteopathic Medicine, will present at the event.
Palatin's approach aims to improve treatment adherence and long-term weight management by addressing issues like side effects and a plateau in weight loss, which often lead to high discontinuation rates among patients using current treatments. By leveraging combination therapy, the company anticipates better outcomes for patients' health and quality of life.
The company has previously demonstrated the efficacy of bremelanotide in reducing food intake and weight in obese patients through clinical studies. These findings support the ongoing research into MCR4 agonists as a potential treatment for obesity, a condition that poses significant health risks and economic burdens globally.
The information for this article is based on a press release statement from Palatin Technologies, Inc.
InvestingPro Insights
As Palatin Technologies (NYSE American: PTN) embarks on its Phase 2 clinical study for obesity treatment, investors may find it useful to consider the company's financial health and market performance. According to recent data from InvestingPro, Palatin Technologies has a notable revenue growth of 146.2% over the last twelve months as of Q2 2024, indicating a substantial increase in sales. This growth is further emphasized by a quarterly revenue surge of 98.18% in Q2 2024. Despite these impressive growth figures, it's important to note that the company is not currently profitable, with a gross profit margin of -225.96% over the same period, reflecting significant costs relative to sales.
InvestingPro Tips highlight that while Palatin Technologies has more cash than debt on its balance sheet, which could provide some financial flexibility, the company is rapidly burning through cash. This is a critical factor for investors to monitor, especially as Palatin invests in its clinical trials. Furthermore, the company has experienced a significant return over the last week, with a price total return of 8.72%. However, the price has fallen significantly over the last three months, with a total return of -50.53%.
For investors seeking more in-depth analysis, there are additional tips available on InvestingPro, which could provide further insights into Palatin Technologies' financial health and market outlook. Interested readers can find these tips by visiting InvestingPro. And for those considering a subscription, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. This offer gives access to a wealth of financial data and expert analysis to inform your investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.