NEW HAVEN, Conn., Nov. 13, 2017 (GLOBE NEWSWIRE) — Melinta Therapeutics, Inc. (NASDAQ:MLNT) a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, announced today that the company’s partner has initiated a Phase 2 clinical study of topical radezolid for the treatment of mild-to-moderate acne vulgaris.
The Phase 2 study will enroll approximately 48 individuals with moderate-to-severe facial acne vulgaris who will be randomized in a double-blind fashion to receive a topical formulation of radezolid or placebo that they will apply twice daily for 12-weeks. Primary endpoints will include the Investigator’s Global Assessment (score of “clear” or “almost clear”) and the absolute change from baseline of acne lesion count(s) in each treatment group. The study is expected to complete enrollment in the second half of 2018.
“Radezolid for acne vulgaris has progressed extremely well though preclinical and clinical development to date” commented Sue Cammarata, Melinta’s chief medical officer. “With resistance to currently available topical antibiotics rising, we believe that radezolid could be an important treatment option for physicians and patients affected by acne vulgaris and are very pleased it is moving into Phase 2 development.”
In January 2015, Melinta structured an agreement with a third party for topical indications of radezolid. The deal structure provides Melinta with a potential long-term financial return and affords Melinta the opportunity to participate in radezolid’s future development and commercialization.
Radezolid is a second-generation oxazolidinone antibiotic discovered by Melinta scientists using proprietary, structure-based design, to achieve higher ribosomal binding affinity, minimal off-target activity, and a broader spectrum of antimicrobial activity than is currently available in the class. For more information, please visit the company website.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to saving lives threatened by the global public health crisis of bacterial infections, through the development and commercialization of novel antibiotics that provide new and better therapeutic solutions. Melinta’s lead product is Baxdela, an antibiotic approved by the US FDA for use in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Melinta also has an extensive pipeline of preclinical and clinical stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this pipeline provides Melinta with the unique ability to provide doctors and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit www.melinta.com for more information.
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Certain statements in this communication constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for the company include, but are not limited to: liquidity and trading market for shares following the consummation of the merger; risks related to the costs, timing and regulatory review of the company’s studies and clinical trials, including its ability to address the issues identified by the FDA in the complete response letter relating to the company’s new drug applications for solithromycin for community acquired bacterial pneumonia; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; inability or the delay in obtaining required regulatory approvals for product candidates, which may result in unexpected cost expenditures; failure to realize any value of certain product candidates developed and being developed, in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; inability to commercialize and launch any product candidate that receives regulatory approval, including Baxdela; the company’s anticipated capital expenditures, its estimates regarding its capital requirements and its need for future capital; uncertainties of cash flows and inability to meet working capital needs; cost reductions that may not result in anticipated level of cost savings or cost reductions; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the company’s products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; loss of or diminished demand from one or more key customers or distributors; unexpected cost increases and pricing pressures; the possibility of economic recession and its negative impact on customers, vendors or suppliers; and risks associated with the possible failure to realize certain benefits of the merger, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond the company’s ability to control or predict.
Other risks and uncertainties are more fully described in the company’s Annual Report on Form 10-K for the year ended December 31, 2016, as amended by Form 10-K/A filed with the SEC on April 13, 2017, and in other filings that the company has made and that the company will make with the SEC, including the proxy statement described below under “Important Information and Where to Find It.” Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release or presentation speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.
Important Information and Where to Find It
Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by the company with the SEC at the SEC’s website (http://www.sec.gov), at the company’s website (http://ir.melinta.com/), or by writing to the Secretary, Melinta Therapeutics, Inc., at firstname.lastname@example.org.
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