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Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

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Vanda Pharmaceuticals Inc. (VNDA) has received FDA approval for the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis, a common fungal infection of nails. VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor, and the new treatment is a significant milestone in developing potential therapies for this disorder. The current therapies for onychomycosis include topical agents JUBLIA® (efinaconzole), KERYDIN® (tavaborole), and PENLAC® (ciclopirox). This is the first FDA approval for a new onychomycosis treatment since 2014.
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The FDA's approval of the IND application for VTR-297 marks a significant advancement in the treatment landscape for onychomycosis, a condition with a notable prevalence in the U.S. population. The development of VTR-297, a histone deacetylase (HDAC) inhibitor, is particularly noteworthy given the stagnation in new treatments since 2014. HDAC inhibitors have a mechanism of action that regulates gene expression by altering the chromatin structure and have been studied extensively in cancer research. Their application in antifungal therapy suggests a novel approach that could potentially offer improved efficacy or safety profiles over existing treatments.

From a medical research perspective, the approval to proceed with clinical studies is a critical step towards addressing an unmet medical need. Given the indirect implications of onychomycosis on conditions such as diabetic foot ulcers, a new effective treatment could have far-reaching benefits beyond cosmetic improvement. It is essential to monitor the clinical trial outcomes for safety and efficacy data, which will be pivotal in determining the potential market impact of VTR-297.

The introduction of VTR-297 into clinical trials is likely to be received positively by the market, considering the lack of innovation in onychomycosis treatments over the past decade. The approval by the FDA signifies a level of confidence in the preliminary data surrounding the drug's safety and mechanism of action. From a market perspective, the success of VTR-297 could disrupt the current market, which is dominated by topical agents like JUBLIA®, KERYDIN® and PENLAC®. As Vanda Pharmaceuticals progresses through clinical trials, investor attention will be on the potential for VTR-297 to capture market share from these established treatments.

Furthermore, the economic impact of a new onychomycosis treatment could be substantial if VTR-297 demonstrates superior efficacy or a better safety profile. The drug's success could lead to significant revenue growth for Vanda Pharmaceuticals, making it an area of interest for investors monitoring the pharmaceutical sector. It is crucial to assess the ongoing clinical trial results and anticipate the competitive dynamics that VTR-297 might introduce upon successful development and commercialization.

The approval of the IND for VTR-297 is likely to have financial implications for Vanda Pharmaceuticals, particularly in terms of R&D expenditure and potential future revenues. Investors should consider the costs associated with the upcoming clinical trials and the impact on the company's financial health. The investment in the development of VTR-297 could strain the company's short-term finances but may be justified by the long-term potential of the drug.

Given the high prevalence of onychomycosis and the absence of new treatments since 2014, there is a significant market opportunity for VTR-297. Should the clinical trials prove successful and the drug gains market approval, Vanda Pharmaceuticals could see a considerable increase in its market valuation. However, it is important to caution that drug development is inherently risky and many compounds fail to make it through the clinical trial phases. Investors should weigh the potential benefits against the risks associated with the drug's development stages.

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis.

Onychomycosis, or tinea unguium, is a fungal infection of the nail. Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the nail bed), and nail plate thickening. Onychomycosis accounts for one half of all nail disease with an estimated U.S. prevalence of up to 14%.1 In addition to cosmetic issues, onychomycosis infection may indirectly decrease peripheral circulation, thereby worsening conditions such as venous stasis and diabetic foot ulcers.2

"The initiation of clinical studies with VTR-297 in the treatment of onychomycosis is an important milestone in studying and developing potential new therapies for this common disorder," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board.

VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor with activity against dermatophytes and fungi, originally isolated from the yeast species Streptomyces hygroscopicus as an antifungal antibiotic, first described in 1976.3 Current therapies for onychomycosis include topical agents JUBLIA® (efinaconzole), KERYDIN® (tavaborole), and PENLAC® (ciclopirox). There have not been any new onychomycosis treatments approved by the FDA since 2014.4

References

  1. Centers for Disease Control and Prevention. Fungal Nail Infections. Updated September 13, 2022. Accessed January 30, 2024. Available online: https://www.cdc.gov/fungal/nail-infections.html
  2. Scher, R. Onychomycosis: a significant medical disorder. J Am Acad Dermatol. 35, S2–5 (1996). Available online: https://doi.org/10.1016/s0190-9622(96)90061-4
  3. Tsuji, N., Kobayashi, M., Nagashima, K., Wakisaka, Y., Koizumi, K. A New Antifungal Antibiotic, Trichostatin. J Antibiot (Tokyo). 1976 Jan;29(1):1-6. Available online: https://doi.org/10.7164/antibiotics.29.1
  4. Markham, A. Tavaborole: First Global Approval. Drugs 74, 1555–1558 (2014). Available online: https://doi.org/10.1007/s40265-014-0276-7

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this press release, including, but not limited to statements regarding the estimated prevalence of onychomycosis and the development of new antifungals, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the accuracy of the reporting and diagnosis of onychomycosis and onychomycosis cases and the ability to successfully complete the clinical development of, and obtain regulatory approval for, VTR-297 in the treatment of onychomycosis. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.  

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com

 

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SOURCE Vanda Pharmaceuticals Inc.

The FDA approval for VTR-297 is significant as it marks a milestone in developing potential therapies for onychomycosis, a common disorder affecting a large population.

VTR-297 is a small molecule histone deacetylase (HDAC) inhibitor with activity against dermatophytes and fungi. It was originally isolated from the yeast species Streptomyces hygroscopicus as an antifungal antibiotic.

The current therapies for onychomycosis include topical agents JUBLIA® (efinaconzole), KERYDIN® (tavaborole), and PENLAC® (ciclopirox).

The last new onychomycosis treatment approved by the FDA was in 2014.
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vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients.