SAN DIEGO, Calif., July 17, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the results from the company's Phase 2 study of VK5211 in patients recovering from hip fracture have been selected for presentation as part of the oral plenary session of the American Society for Bone and Mineral Research (ASBMR) 2018 annual meeting. The presentation will highlight the efficacy, safety and tolerability data from the completed Phase 2 clinical trial. The ASBMR 2018 annual meeting is being held September 28 – October 1, 2018 in Montreal, Quebec, Canada.
Details of Viking's scheduled presentation are as follows:
As previously reported, the top-line data from this study showed that the trial successfully achieved its primary efficacy endpoint, demonstrating statistically significant, dose dependent increases in lean body mass, less head, among patients treated with VK5211, as compared to placebo. The study also achieved important secondary endpoints, demonstrating statistically significant improvements in appendicular lean body mass and total lean body mass compared to placebo. Patients receiving VK5211 also demonstrated numerical improvements in certain exploratory assessments of functional performance. VK5211 demonstrated encouraging safety and tolerability, with no drug-related serious adverse events reported in this study.
"We are excited to have the opportunity to present the results of our Phase 2 study at this important conference. The selection of these data for presentation at the ASBMR oral plenary session highlights the importance of novel muscle-targeting therapeutics in areas of high unmet need, such as the hip fracture recovery setting," stated Brian Lian, Ph.D., Viking's chief executive officer. "This challenging population, which includes many older, medically fragile patients, is in need of new treatments that can safely and effectively help improve recovery. We look forward to sharing the detailed results from our study at the conference."
About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo. The company's second clinical program is evaluating VK2809, a small molecule thyroid beta agonist in a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and hypercholesterolemia. The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Additional programs include novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia. Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
Forward-Looking StatementsViking cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "estimate," "think," "may," "could," "will," "would," "should," "continue," "potential," "likely," "opportunity" and similar expressions or variations of such words are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements. These statements are based on Viking's current beliefs and expectations. These forward-looking statements include statements regarding the amount and anticipated use of proceeds from the offering. The inclusion of forward-looking statements should not be regarded as a representation by Viking that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties associated with market conditions and other risks and uncertainties inherent in Viking's business, including those described in Viking's periodic filings with the SEC and the prospectus supplement and related prospectus for this offering filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. There may be events in the future that Viking is unable to predict, or over which it has no control, and Viking's business, financial condition, results of operations and prospects may change in the future. Viking assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made, except as required by applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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Details of Viking's scheduled presentation are as follows:
- Title: VK5211, a Novel Selective Androgen Receptor Modulator (SARM), Significantly Improves Lean Body Mass in Hip Fracture Patients: Results of a 12-Week Phase 2 Trial
- Presentation Number: 1072
- Presentation Type: Oral Presentation
- Session: Plenary Oral - Osteoporosis Treatment
- Session Date/Time: Sunday, September 30, 9:45 am - 11:00 am Eastern
- Presentation Time: 10:15 am - 10:30 am Eastern
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As previously reported, the top-line data from this study showed that the trial successfully achieved its primary efficacy endpoint, demonstrating statistically significant, dose dependent increases in lean body mass, less head, among patients treated with VK5211, as compared to placebo. The study also achieved important secondary endpoints, demonstrating statistically significant improvements in appendicular lean body mass and total lean body mass compared to placebo. Patients receiving VK5211 also demonstrated numerical improvements in certain exploratory assessments of functional performance. VK5211 demonstrated encouraging safety and tolerability, with no drug-related serious adverse events reported in this study.
"We are excited to have the opportunity to present the results of our Phase 2 study at this important conference. The selection of these data for presentation at the ASBMR oral plenary session highlights the importance of novel muscle-targeting therapeutics in areas of high unmet need, such as the hip fracture recovery setting," stated Brian Lian, Ph.D., Viking's chief executive officer. "This challenging population, which includes many older, medically fragile patients, is in need of new treatments that can safely and effectively help improve recovery. We look forward to sharing the detailed results from our study at the conference."
About Viking Therapeutics, Inc. Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo. The company's second clinical program is evaluating VK2809, a small molecule thyroid beta agonist in a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and hypercholesterolemia. The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Additional programs include novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia. Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
Forward-Looking StatementsViking cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "estimate," "think," "may," "could," "will," "would," "should," "continue," "potential," "likely," "opportunity" and similar expressions or variations of such words are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements. These statements are based on Viking's current beliefs and expectations. These forward-looking statements include statements regarding the amount and anticipated use of proceeds from the offering. The inclusion of forward-looking statements should not be regarded as a representation by Viking that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties associated with market conditions and other risks and uncertainties inherent in Viking's business, including those described in Viking's periodic filings with the SEC and the prospectus supplement and related prospectus for this offering filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. There may be events in the future that Viking is unable to predict, or over which it has no control, and Viking's business, financial condition, results of operations and prospects may change in the future. Viking assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made, except as required by applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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SOURCE Viking Therapeutics, Inc.
