Sol-Gel Announces Pipeline Update and Future Development Plans
Sol-Gelinvestigational SGT-510 was found to be more effective than roflumilast cream, 0.3%, in a human xenograft psoriasis animal model Sol-Gelis developing tapinarof cream, 1%, aiming to offer product formulation innovations and increased affordability for patients compared to the brand expected to be launched
- Our proof-of-concept study for SGT-210 (erlotinib gel) in palmoplantar keratoderma patients has been completed and indicated a possible modest improvement
Sol-Gelto host Conference Call today at 8:00 am U.S.EDT to discuss the data and provide a corporate update
The study was conducted at the
"Our model has been proven to predict efficacy for novel approaches in the treatment of psoriasis, providing very valuable information to the companies leveraging this assay,” commented Professor Gilhar.
All tested articles were applied for 14 days either once or twice daily:
- Nine (9) out of 10 animals fully recovered following a twice-daily application of dexamethasone (the positive control);
- None (0) out of 10 recovered following a once-daily application of vehicle cream (the negative control);
- Three (3) out of 10 animals recovered following a once-daily application of roflumilast cream, 0.3% that was formulated by
Sol-Gelaccording to conventional methods of cream formulation;
- Six (6) out of 10 animals fully recovered following once-daily application of SGT-510.
Based on these results,
Management to Host Conference Call Today
To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:
The live conference call and replay can also be accessed by audio webcast here and also on the Investor Relations section of the Company’s website, located at https://ir.sol-gel.com/investor-relations.
Roflumilast is a selective, long-acting inhibitor of Phosphodiesterase-4 (PDE4). It is the active ingredient in the
A roflumilast cream 0.3% formulation is under investigation as a once-daily treatment of plaque psoriasis and positive Phase 3 results were recently reported.
Tapinarof is a novel, first-in-class, small-molecule topical therapeutic aryl hydrocarbon receptor (AhR)–modulating agent. It is in clinical development for the treatment of psoriasis and atopic dermatitis. The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a ligand-dependent transcription factor, leading to the downregulation of proinflammatory cytokines, including interleukin 17, and regulation of skin barrier protein expression to promote skin barrier normalization.
Erlotinib is a tyrosine kinase receptor inhibitor which acts on the Epidermal Growth Factor Receptor (EGFR). It is the active pharmaceutical ingredient (API) in Tarceva® which is used to orally treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Currently, there are no topical products of erlotinib, and erlotinib is not approved for plaque psoriasis.
Wavelength is a customer-focused backward-integrated world-class developer and manufacturer of Active Pharmaceutical Ingredients (APIs). It is the independent company of choice for pharmaceutical industry leaders that require advanced API solutions and reliable supply to gain sustainable competitive advantage. The company is on the same wavelength as its customers – a partner in tune with the results required to best support their needs. Founded in
Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of TWYNEO® under investigation for the treatment of acne vulgaris with an NDA filed with the FDA and a PDUFA goal date set for
This press release contains “forward-looking statements” within the meaning Securities of the Private Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions, including statements regarding the timing for the initiation of a Phase I study for SGT-510, the intellectual property protection that would be provided by a patent for SGT-210, the anticipated status of patents at the time of an NDA submission for SGT-210, the timing of the launch of our tapinarof drug product and the timing of a test of erlotinib with a much higher concentrations in an animal model and a second POC study on PPK patients. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk of a delay in receipt of approval, if any, of the NDA for TWNYEO, the risk of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk of a delay in the initiation of a Phase I study for SGT-510, the risk that a patent for SGT-210 will not provide the anticipated intellectual property protection, the risk that all Orange Book-listed DALIRESP® patents will not have expired by the time of our NDA application for SGT-21 and that a consequent 30-month stay will required, the risk of a delay in the launch of our tapinarof drug product, the risk of a delay the timing of a test of erlotinib with a much higher concentrations in an animal model and the risk of a delay in a second POC study on PPK patients, risks relating to the effects of COVID-19 (coronavirus) as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 4, 2021 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.
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Chief Financial Officer
Source: Sol-Gel Technologies Ltd.