NeuroBo Pharmaceuticals Acquires ANA Therapeutics for Late-Stage Oral Antiviral Development Program
"This is an exciting and transformative acquisition for NeuroBo that expands our pipeline with a late-stage clinical development program that addresses the urgent need for new treatments to address COVID-19, a highly-infectious and often deadly virus," stated Richard J. Kang, Ph.D., President and Chief Executive Officer of NeuroBo. "ANA-001 is advancing through the 505(b)(2) clinical pathway, which allows us to leverage earlier data on niclosamide and streamlines and accelerates the timelines to bring this potentially life-saving therapy to patients suffering with COVID-19. As a result, the development timeline supports a number of value-creating milestones over the coming 12 to 18 months, including the data readout of the Phase 2 portion of the trial, expected in the third quarter of 2021."
"While the introduction of vaccines is expected to play a significant role in stemming the tide of the COVID-19 pandemic, the ongoing complexities and mutation of the disease will require therapies to treat the infected population for the foreseeable future," commented
"We are delighted to join with the NeuroBo team in order to bring ANA-001 to the millions of patients infected with COVID-19. NeuroBo has the leadership and platform to support the accelerated development of this important compound as a potential treatment for this viral pandemic," said
About Niclosamide and ANA-001
ANA-001 is a proprietary oral niclosamide formulation in development as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators). Niclosamide is a potential oral antiviral and anti-inflammatory agent with a long history of use and a well-understood safety profile in humans. ANA-001 is currently being studied in a 60-subject Phase 2/3 clinical trial conducted at up to 20 clinical sites in the
Specifically, studies have shown that niclosamide prevents replication of SARS-CoV-2 at very low concentrations and that the compound appears to exhibit three distinct mechanisms of action: 1) acting as a potent antiviral to a broad homology of other viruses including influenza; 2) reducing inflammation without suppressing the immune system; and 3) providing bronchodilation, which is a useful pulmonary mechanism for at-risk patients with underlying cardiovascular and/or pulmonary conditions.
As a result, the company believes ANA-001 has the potential to reduce the viral load and inflammation associated with cytokine dysregulation, acute respiratory distress syndrome (ARDS), and coagulation abnormalities and thus improve time to clinical improvement as defined as hospital discharge recorded using the WHO Ordinal Scale for Clinical Improvement.
The company believes ANA-001 has distinct competitive advantages in this market, including (1) offering an effective treatment for moderate to severe COVID-19 (patients not requiring ventilators); (2) having 3+ year marketing exclusivity in the
Clinical Development Plans for ANA-001
The second phase of the trial is expected to enroll several hundred patients, with the primary endpoints of the study being median time to hospital discharge, safety and tolerability. Secondary objectives will evaluate clinical improvement and the need and duration for rescue therapy.
Under the terms of the acquisition agreement, ANA became a wholly-owned subsidiary of NeuroBo and ANA equity holders were issued an aggregate of approximately 3.24 million shares of Neurobo common stock, representing 19.7% of NeuroBo's outstanding shares. ANA shareholders will receive additional payments (in cash or NeuroBo common shares) upon the achievement of various development and net sales milestones for ANA-001 and will also receive royalties based on net sales of ANA-001.
Three key executives from ANA Therapeutics have joined the NeuroBo management team including,
For more information visit: https://www.neurobopharma.com.
Forward Looking Statements
Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the development timeline for niclosamide for the treatment of COVID-19, the market size for COVID-19-related therapeutics and the competitive advantages of ANA-001, the potential benefits of ANA-001 as a treatment for patients with moderate to severe COVID-19 (patients not requiring ventilators), and potential milestone payments and royalties that may become due to the former equity holders of ANA under the acquisition agreement. Forward-looking statements are usually identified by the use of words, such as "believes," "anticipates," "expects," "intends," "plans," "may," "potential," "will," "could" and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. These factors, risks and uncertainties include, but are not limited to: the failure to obtain all of the benefits or recognize all of the synergies anticipated from the ANA acquisition; the integration of ANA potentially diverting management resources from operational matters and other strategic opportunities; the effect of future milestone payments and royalties specified in the acquisition agreement on the results of operations and financial position of NeuroBo; the occurrence of health epidemics or contagious diseases, such as COVID-19, and potential effects on NeuroBo's business, clinical trial sites, supply chain and manufacturing facilities; NeuroBo's ability to continue as a going concern; the timing of completion of NeuroBo's planned clinical trials, including with respect to ANA-001; the timing of the availability of data from NeuroBo's clinical trials, including with respect to ANA-001; the clinical utility, potential benefits and market acceptance of NeuroBo's product candidates, including ANA-001; ; and NeuroBo's need for additional financing to fulfill its stated goals; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K and in our other filings with the