VYNE Therapeutics Announces Initiation of Investigator Initiated Trial Evaluating AMZEEQ® (Minocycline) with Oral Isotretinoin in Patients with Moderate to Severe Acne
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:
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 indicaed.
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:
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.
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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