BRIDGEWATER, N.J., July 19, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced the initiation of an investigator initiated trial (“IIT” or “study”) evaluating the safety and efficacy of AMZEEQ® (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne. The study is supported by VYNE and is being conducted by the Austin Institute for Clinical Research in Texas.
“Isotretinoin has been widely used for the management of severe or scarring acne since its introduction as Accutane® in the 1980s. However, its teratogenic properties means that patients must be monitored very carefully and its use as a chronic treatment is limited,” said Dr. Edward Lain, MD MBA FAAD, practicing dermatologist at Sanova Dermatology in Austin, Texas, and Principal Investigator for the study. “The combination of an oral isotretinoin and a topical minocycline presents a combined proposition of achieving control of severe disease coupled with long-term disease management possibilities,” he said. Dr. Lain also served as an investigator in the clinical trials for AMZEEQ and is a consultant to VYNE.
“AMZEEQ is a valuable topical treatment option for moderate to severe acne. As a single agent, it has demonstrated strong efficacy as well as a very favorable side effect profile. We are pleased that AMZEEQ is also receiving interest from the dermatology community to study AMZEEQ as part of a combination regimen with oral isotretinoin for both acute and chronic management of the disease,” said Dr. Iain Stuart, Chief Scientific Officer of VYNE.
IIT Study Description
The study is designed to assess the impact of AMZEEQ and oral isotretinoin concomitant use on the cutaneous adverse reactions often seen in the first few weeks of treatment with oral isotretinoin alone. These cutaneous adverse reactions are a leading contributory factor in premature treatment abandonment. Additionally, the study will evaluate the efficacy and safety of adding AMZEEQ to the indicated 20-week oral isotretinoin treatment course with a focus on whether AMZEEQ can impact the time to onset of efficacy and overall efficacy rates when compared to oral isotretinoin monotherapy. Finally, because prescribers often seek alternative treatments for patients once a course of oral isotretinoin has been completed, the study will evaluate the safety and efficacy of AMZEEQ subsequent to a course of oral isotretinoin for an additional 24 weeks of treatment.
The IIT is a randomized, multicenter, evaluator-blinded, study to evaluate the safety, tolerability, and efficacy over a 20-week treatment period of oral isotretinoin and AMZEEQ concomitant use compared to oral isotretinoin only in the treatment of patients with moderate to severe acne vulgaris. In addition, maintenance of clinical response by AMZEEQ only treatment will also be evaluated for a further 24 weeks after withdrawal of oral isotretinoin treatment. Patients with qualifying lesion counts (inflammatory and comedonal acne lesions) and Investigator’s Global Assessment (IGA) of acne severity scores will be randomized in a 1:1 ratio to one of two treatment groups:
Group A patients will receive 20 weeks of both oral isotretinoin and topical AMZEEQ® treatment concomitantly, followed by a further 24 weeks of AMZEEQ only treatment, Group B patients will receive 20 weeks of oral isotretinoin treatment only, followed by a further 24 weeks of topical AMZEEQ only treatment.
The efficacy endpoints are percent change from baseline in inflammatory and comedonal lesion counts at each visit, and IGA Treatment Success at each visit, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from Baseline. The safety assessments will include treatment emergent adverse events (TEAEs) (volunteered, observed, and elicited by general questioning in a non-suggestive manner), physical examinations, urinary pregnancy tests, clinical laboratory tests, vital signs, and local skin tolerability assessments (including itching, stinging/burning, dryness, edema, scaling, erythema, and hyperpigmentation). The planned enrollment is approximately 30 patients to be enrolled from two sites in the USA. For more information, refer to ClinicalTrials.gov Identifier: NCT04940767.
INDICATIONS AND USAGE
AMZEEQ (minocycline) topical foam, 4% is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.
Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.
IMPORTANT SAFETY INFORMATION
Contraindications: Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.
Warnings and Precautions
Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:
- Teratogenic effects, inhibition of bone growth & permanent tooth discoloration: Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth.
- Clostridium difficile associated diarrhea (CDAD): If CDAD occurs, discontinue AMZEEQ.
- Hepatotoxicity & metabolic effects: If renal impairment exists or if liver injury suspected, discontinue AMZEEQ.
- Central nervous system effects: Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operate heavy machinery.
- Intracranial hypertension: Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue AMZEEQ immediately if symptoms occur.
- Autoimmune syndromes: Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue AMZEEQ immediately if symptoms occur.
- Photosensitivity: Patients should minimize or avoid exposure to natural or artificial sunlight while using AMZEEQ. Advise patients to discontinue treatment with AMZEEQ at the first evidence of sunburn.
- Hypersensitivity reactions: Discontinue AMZEEQ immediately if symptoms of anaphylaxis, serious skin reactions, erythema multiforme, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome occur.
- Tissue hyperpigmentation: Discoloration of organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and heart valves.
- Superinfection: Overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue AMZEEQ and institute appropriate therapy.
Adverse Reactions: The most common adverse reaction reported during clinical trials of AMZEEQ was headache.
To report SUSPECTED ADVERSE REACTIONS, contact Foamix Pharmaceuticals Inc. at 1-844-375-3673 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see full Prescribing Information.
About VYNE Therapeutics Inc.
VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.
With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at AMZEEQ.com and ZILXI’s Full Prescribing Information at ZILXI.com.
For more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
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VYNE Therapeutics Inc.
Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates, including AMZEEQ, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the outcome of investigator initiated trials involving AMZEEQ, adverse events associated with the development and commercialization of our product candidates and approved products; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ prescription reimbursement; our ability to negotiate contracts with pharmacy benefit managers and other third-parties; the eligible patient base and commercial potential of AMZEEQ or any of VYNE’s other products or product candidates; risks of potential litigation by third-parties regarding infringement of third-party intellectual property; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; volatility in our stock price may result in rapid and substantial increases or decreases in our stock price that may or may not be related to our operating performance or prospects; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.