Enrollment is now in phase 2a of the VYNE Therapeutics Inc. trial. Encouraged by the Phase 1B efficacy data, as noted by the HC Wainwright & Co.
VYNE Therapeutics Inc. (VYNE: NASDAQ) Finished enrolling patients, on schedule, in the Phase 2A trial evaluating FMX114 in mild to moderate atopic dermatitis, and results are expected in late July and early August of this year, according to Joseph Pantgenis, an analyst at HC Wainwright & Co at Search June 17 Note.
It should also be noted that HC Wainwright’s target price on VYNE of $7 per share indicates a significant potential return for investors given the biopharmaceutical company’s current share price is approximately $0.50.
In a Phase 2A, double-blind study, 25 enrolled patients will receive FMX114 and vehicle treatment four times daily for four weeks, relaying Pantginis. The objective is to further evaluate the safety, pharmacokinetics, and efficacy of the company’s proprietary combination of tofacitinib and fingolimod.
Pantginis highlighted that the results for part 1b of stage 1b/2a are encouraging. Patients showed a significant reduction in the signs and symptoms of atopic dermatitis after 2 weeks of FMX114 treatment. The treatment is also proven to be safe.
In the report, Pantginis also provided updates on two immune-modified VYNE assets, VYN201 and VYN202. These are the BET inhibitors derived from the InhiBET platform.
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“BET proteins are key regulators of inflammation and tumorigenesis through transcriptional modulating mechanisms,” the analyst explained.
As for VYN201, a locally administered pan-bromodomain inhibitor, it “has shown strong preclinical efficacy on a number of indicators of inflammation,” Pantginis noted. Newly released data on VYN201 show that it safely provides immunosuppression.
VYNE intends to pursue VYN201 in the case of vitiligo first, due to market potential, “impressive raw data” and a significant unmet need, Pantginis wrote. “Current treatments for vitiligo are limited in their ability to generate a rapid response, are usually stressful for patients, and have limited durability.”
As such, the company is targeting H2/22 to launch a Phase 1a/b clinical trial for VYN201 vitiligo.
“This is an important step forward for VYNE and its InhiBET platform, and we look forward to updates in the coming months,” Pantgenis added.
For the later phase of VYNE, orally administered VYN202, biologics have not yet decided which systemic indication to follow first, but options include rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis/Crohn’s disease, and multiple sclerosis. VYNE is looking forward to beginning, later this year, a Phase 1 trial of VYN202 in the signal of your choice.
HC Wainwright & Co. acquired. A buy rating on VYNE.
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HCWainwright & Co. Disclosures , VYNE Therapeutics, Inc. June 17, 2022
HC Wainwright & Co, LLC (the “Company”) is a member of FINRA, SIPC, and a US registered broker-dealer.
I’m Joseph Pantgenis, Ph.D. and Emanuela Branchte, Ph.D. certify that 1) all opinions expressed in this report accurately reflect my personal opinions about any and all subject securities or issuers discussed; and 2) no part of my salary was, or would be, directly or indirectly related to the specific recommendation or opinions expressed in this research report; 3) Neither I nor any of my family members is an official, director, or member of the advisory board of these companies.
Neither the research analyst nor the research analyst family has a financial interest in the securities of VYNE Therapeutics, Inc. (including, without limitation, any option, right, security, future position, long or short). As of May 31, 2022, neither the Company nor its affiliates beneficially owns 1% or more of any class of common stock of VYNE Therapeutics, Inc.. Neither the Research Analyst nor the Company knows or has reason to know any other material conflict of interest in At the time of publication of this research report.
The research analyst primarily responsible for preparing the report does not receive compensation based on any specific investment banking services or transactions, but is compensated based on factors including total revenue and the company’s profitability, a large part of which is derived from investment banking services. The Company or its affiliates have received compensation from VYNE Therapeutics, Inc. For non-investment banking services in the past 12 months. Neither the Company nor its affiliates have received any compensation from VYNE Therapeutics, Inc. for investment banking within twelve months prior to that, but will seek compensation from the companies mentioned in this report for investment banking within three months after publication of the research report. The company does not create a marketplace in VYNE Therapeutics, Inc. As of the date of this research report.
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