Palatin Provides Corporate Update and Highlights Strategic Priorities for Calendar Year 2024
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The recent updates by Palatin Technologies regarding their clinical pipeline are indicative of significant strides in the development of treatments for various conditions. The completion of patient enrollment for the Phase 3 MELODY-1 study in Dry Eye Disease (DED) and the upcoming data readouts for both DED and Ulcerative Colitis (UC) treatments are critical milestones. These developments could potentially lead to new treatment options for patients, addressing unmet medical needs. Moreover, the advancement of treatments for obesity and male sexual dysfunction underscores the company's commitment to addressing complex health issues through targeted receptor modulation.
From an investment perspective, the successful progression of these clinical trials could result in increased investor confidence and potential partnerships or licensing deals. The obesity treatment market, in particular, is of high interest due to the growing prevalence of the condition globally. The combination of a Melanocortin Receptor 4 (MCR4) agonist with Glucagon Like Peptide-1 (GLP-1) could offer a novel approach to weight management, potentially distinguishing Palatin's product from existing therapies. The divestiture of Vyleesi, with the upfront payment and sales-based milestones, provides Palatin with immediate capital infusion and a future revenue stream contingent on product performance, which could bolster the company's financial position and support ongoing research and development activities.
Palatin Technologies' strategic decision to divest Vyleesi and focus on its core development pipeline is a move that could streamline the company's operations and concentrate resources on areas with higher growth potential. The transaction could enhance the company's cash flow, providing up to $171 million, which is substantial for a company of Palatin's size. This financial boost is likely to be closely watched by investors, as it may affect the company's burn rate and extend its runway for further development of its pipeline products.
Furthermore, the expected data readouts in 2024 are significant events that could influence the company's stock volatility. Positive results could lead to stock appreciation, while any setbacks might have a negative impact. The market's reaction to these events will depend on the outcomes relative to the expectations set by the company and the medical community. The potential regulatory milestones from Fosun and Kwangdong licenses also add layers of financial incentive and market expansion opportunities, which could have a favorable impact on the company's valuation.
The biotech sector is driven by innovation and the successful progression of clinical trials. Palatin's focus on melanocortin receptor modulation positions the company within a niche but promising segment of the market. The receptor system's role in various physiological processes, including inflammation, metabolism and sexual function, presents multiple therapeutic avenues for exploration. The upcoming Phase 3 and Phase 2 clinical trial readouts for DED and UC, respectively, are crucial for establishing efficacy and safety profiles of the company's lead compounds. Positive outcomes could not only validate Palatin's technological approach but also attract attention from larger pharmaceutical entities for potential acquisitions or collaborations.
Moreover, the initiation of clinical studies for obesity and male sexual dysfunction represents a strategic move to tap into lucrative markets with high patient populations. The obesity market, in particular, is rapidly expanding and the combination therapy approach being pursued by Palatin could offer competitive advantages over existing treatments. The company's ability to execute on these clinical programs and deliver compelling data will be a key determinant of its future success and positioning within the biotech landscape.
- Dry Eye Disease (DED): PL9643 MELODY-1 Phase 3 Study
- Data Base Lock 2H January 2024
- Topline Data Readout Expected Early 1Q Calendar Year 2024
- Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients
- Interim Analysis Data Readout on Track for 1Q Calendar Year 2024
- Topline Results Expected in 2Q Calendar Year 2024
- Obesity: Melanocortin Receptor 4 (MCR4) Agonist + Glucagon Like Peptide-1 (GLP-1)
- Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024
- Topline Results Expected in 2H Calendar Year 2024
- Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients that do not Respond to PDE5i Monotherapy
- Phase 2 Clinical Study Targeted to Start 1Q Calendar Year 2024
- Topline Results Expected in 2H Calendar Year 2024
- Vyleesi®
- Completed Asset Sale to Cosette Pharmaceuticals for up to
$171 Million $12 Million $159 Million
- Completed Asset Sale to Cosette Pharmaceuticals for up to
"We made significant operational progress during calendar year 2023 and we believe we are well-positioned for making calendar year 2024 a pivotal and transformative year for Palatin," said Carl Spana, Ph.D., President and CEO of Palatin. "Our internal research and development efforts are focused in areas where we believe we have a high probability of success, product differentiation and the opportunity for a substantial return on our investment. Topline data readout for our Phase 3 PL9643 clinical study for DED is expected early in the first quarter of calendar year 2024. Our Phase 2 study of oral PL8177 in patients with UC is expected to have an interim analysis data readout in the first quarter and topline trial results in the second quarter of calendar year 2024."
Dr. Spana further commented, "We are excited by the significant opportunity of melanocortin-based therapeutics for obesity treatment and believe we are well positioned to deliver selective and efficacious MCR4 long-acting peptides and orally active small molecules. We expect to commence a Phase 2 clinical study of a MCR4 agonist plus a GLP-1 in obese patients in the first quarter of calendar year 2024. In addition, following on our significant expertise in product development to treat sexual dysfunction, we expect to commence a Phase 2 clinical study evaluating bremelanotide co-formulated with a PDE5i for the treatment of ED in patients that do not respond to PDE5i monotherapy in the first quarter of calendar year 2024."
The recently announced divestiture of Vyleesi is consistent with Palatin's strategic decision to concentrate on its robust development and clinical pipeline. Palatin is now focused on developing novel therapeutics that modulate the melanocortin receptor system.
Program Updates and Expected Milestones for 2024
- Anti-Inflammatory / Autoimmune Programs
- PL9643 melanocortin agonist Phase 3 study for the treatment of DED:
- Patient enrollment completed (n=570) in Phase 3 MELODY-1 study
- Data base lock second half of January 2024
- Topline data readout expected early first quarter of calendar year 2024
- Phase 3 safety and efficacy study MELODY-2 and the open label MELODY-3 study are anticipated to commence patient enrollment in the second half of calendar year 2024
- PL8177 oral melanocortin agonist Phase 2 study for the treatment of UC:
- Interim assessment targeted for the first quarter of calendar year 2024
- Topline data readout is expected in the second quarter of calendar year 2024
- Bremelanotide BREAKOUT Phase 2 study in patients with diabetic kidney disease:
- Topline data readout is expected in the second quarter of calendar year 2024
- Metabolic Program (Obesity)
- Presented positive data with bremelanotide, a melanocortin receptor 4 (MCR4) agonist, plus glucagon like peptide-1 (GLP-1) showing increased weight loss and greater glucose control above monotherapy:
- Phase 2 clinical study targeted to start in the first quarter of calendar year 2024
- Topline data readout is expected in the second half of calendar year 2024
- Initiation of investigational new drug (IND) enabling activities for a novel MCR4 selective long-acting agonist expected in the second half of calendar year 2024
- Sexual Health Program (Male Sexual Dysfunction)
- Initiated a clinical development program evaluating bremelanotide co-formulated with a PDE5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy:
- Phase 2 clinical study in PDE5i non-responder ED patients is expected to commence in the first quarter of calendar year 2024
- Topline data readout is expected in the second half of calendar year 2024
- Vyleesi® (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD)
- Completed asset sale to Cosette Pharmaceuticals for up to
$171 million
- Completed asset sale to Cosette Pharmaceuticals for up to
$12 million $159 million $15 million $200 million - Eligible to receive regulatory approval milestones of
$10.5 million $7.5M China ) and Kwangdong ($3.0M - Palatin retained rights and use of bremelanotide for obesity and male erectile dysfunction indications
About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on www.Palatin.com and follow us on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release.
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
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SOURCE Palatin Technologies, Inc.
FAQ
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What is the expected timeline for the topline data readout for the PL9643 MELODY-1 Phase 3 Study?
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What are the anticipated milestones for the PL8177 oral melanocortin agonist Phase 2 study for the treatment of UC in 2024?
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