BOSTON–(BUSINESS WIRE)–NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on multimodal, disease-modifying therapies for neurodegenerative diseases, today reported that the previously announced merger between NeuroBo Pharmaceuticals, Inc., (“NeuroBo”) and Gemphire Therapeutics (Nasdaq: GEMP) closed on December 31, 2019. The new combined company, known as NeuroBo Pharmaceuticals began trading on the Nasdaq exchange under the ticker “NRBO” on December 31, 2019. NeuroBo will focus on advancing the company’s clinical-stage pipeline for neurodegenerative diseases.
“We believe that the closing of the merger signifies a transformative event that will provide NeuroBo with the opportunity to achieve its next level of corporate growth as we continue to advance our promising pipeline for neurodegenerative diseases,” said Richard J. Kang, Ph.D., president and chief executive officer of the combined company. “As we look ahead, we have some important milestones on the horizon. The first study in our Phase 3 program for our lead drug candidate, NB-01, for painful diabetic neuropathy (PDN), will begin screening patients soon in the U.S. and we are designing a first-in-human trial for NB-02, targeted at Alzheimer’s disease and diseases associated with the pathological dysfunction of tau proteins in the brain.”
The company’s novel lead program, NB-01, is an oral drug candidate for painful diabetic neuropathy (PDN). In a randomized, placebo-controlled Phase 2 clinical trial, NB-01 significantly improved pain scores from baseline as measured by the NRS, an 11-point numeric rating scale commonly used in pain studies, and showed an excellent safety profile when compared to retrospective safety data on existing therapies. In pre-clinical studies in animal models of diabetes, NB-01 reduced general inflammation and neuro-inflammation as measured by IL-6 and TNF-α, reduced advanced glycation end products (AGEs), which are implicated in diabetic neuropathy, and elevated levels of nerve growth factor (NGF) to normal physiological levels, which has been shown to promote nerve growth, survival and repair. This multi-component drug approach has the potential to address the underlying mechanisms of PDN, reduce neuropathic pain symptoms and slow disease progression. Initiation of enrollment in the first Phase 3 study with NB-01 is anticipated in the first half of 2020 and will enroll approximately 460 subjects with PDN across the U.S.
NeuroBo’s IND-ready second drug candidate, NB-02, is targeted for the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain. Preclinical animal disease model studies of NB-02 have provided evidence of efficacy and safety in neurodegeneration.
In addition, NeuroBo plans to continue the advancement of gemcabene, which has been in development by Gemphire for the treatment of dyslipidemia. Gemcabene has been studied in more than 1,100 human subjects in a total of 25 Phase 1 and Phase 2 trials with demonstrated efficacy and safety. The combined company expects to submit an application with results of a preclinical mouse safety study to the Food and Drug Administration (FDA) in early 2020 to address a partial clinical hold related to gemcabene’s activation of peroxisome proliferation-activated receptor (PPAR) and, if approved, would be poised to progress into Phase 3 human studies. The combined company will also continue to support the partnership with Beijing SL Pharmaceutical, Co., Ltd. (“Beijing SL”), for gemcabene rights in China.
Immediately after the closing of the merger, NeuroBo shareholders owned 96.24%, and current Gemphire stockholders owned 3.76% of NeuroBo’s common stock. As part of the merger, Gemphire stockholders received non-transferable contingent value rights (CVRs) entitling the holders to receive in aggregate, after the retention of $500,000 by the combined company and certain other permitted deductions, 80% of the net proceeds, if any, in the event the gemcabene assets are sold or licensed during the 10-year period following the closing of the merger or pursuant to the license agreement with Beijing SL.
The combined organization will operate under the leadership of NeuroBo’s new President and Chief Executive Officer, Richard J. Kang, Ph.D., and Chief Medical Officer, Mark Versavel, M.D., Ph.D., MBA. The board of directors of the combined organization is comprised of seven directors: two directors from the former NeuroBo board, one director from the former Gemphire board and four newly appointed members designated by NeuroBo prior to the merger. Ms. Na Yeon (Irene) Kim, M.S., MBA, was appointed as chairman of the board. The corporate headquarters of the combined organization is located in Boston, Massachusetts.
About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc., is focused on novel treatments for neurodegenerative diseases affecting millions of patients worldwide. The company’s multimodal approach has the potential to address the multiple underlying mechanisms of neurodegenerative diseases, alleviate symptoms and slow disease progression. The company’s lead drug candidate, NB-01, for the treatment of painful diabetic neuropathy (PDN) has been shown in a Phase 2 study to significantly reduce pain symptoms associated with PDN with a superior safety profile when compared to currently available treatments. Enrollment in the first study in the Phase 3 program for NB-01 in the U.S. is expected to begin in the first half of 2020, with a target enrollment of approximately 460 subjects with PDN. NeuroBo’s IND-ready second drug candidate, NB-02, is focused on the treatment of Alzheimer’s disease and neurodegenerative diseases associated with the pathological dysfunction of tau proteins in the brain.
NeuroBo Pharmaceuticals was jointly founded by Dr. Roy Freeman, professor of neurology at Harvard Medical School and renowned expert in neuropathic pain, and JK BioPharma Solutions, a biotechnology consulting company, to commercialize natural product-based research into ethical medicines. 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 therapeutic potential, timing and nature of human trials and potential regulatory approval of NeuroBo’s clinical programs and pipeline. 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: NeuroBo’s plans to develop and commercialize its product candidates; the timing of completion of NeuroBo’s planned clinical trials; the timing of the availability of data from NeuroBo’s clinical trials; NeuroBo’s plans to research, develop and commercialize its current and future product candidates; NeuroBo’s ability to successfully collaborate with existing collaborators or enter into new collaborations and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of NeuroBo’s product candidates; NeuroBo’s commercialization, marketing and manufacturing capabilities and strategy; the impact of government laws and regulations; NeuroBo’s ability to protect its intellectual property position; and NeuroBo’s need for additional financing to fulfill its stated goals; and other factors discussed in the “Risk Factors” section of SEC filings the combined company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent NeuroBo’s views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo’s views as of any date subsequent to the date hereof.