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VYNE THERAPEUTICS INC.

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

07/19/2021 | 08:00am EDT

VYNE Therapeutics Inc. 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. 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.


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Financials (USD)
Sales 2021 18,2 M - -
Net income 2021 -70,2 M - -
Net Debt 2021 - - -
P/E ratio 2021 -1,17x
Yield 2021 -
Capitalization 80,9 M 80,9 M -
Capi. / Sales 2021 4,43x
Capi. / Sales 2022 11,3x
Nbr of Employees 106
Free-Float 87,1%
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Number of Analysts 6
Last Close Price 1,57 $
Average target price 6,67 $
Spread / Average Target 325%
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David Domzalski President, Chief Executive Officer & Director
Tyler Zeronda Chief Financial Officer & Treasurer
Iain A. Stuart Chief Scientific Officer
Sharon Barbari Independent Director
Steven L. Basta Independent Director
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