Boston biotech, NeuroBo Pharmaceuticals, has completed its merger with Gemphire Therapeutics, the Michigan-based clinical-stage biopharma.
The newly combined company, known as NeuroBo Pharmaceuticals, will focus on advancing the company’s clinical-stage pipeline for neurodegenerative diseases.
The closing has been hailed as a “transformative event” by Richard J Kang, President and CEO of the combined company, adding that it will provide the opportunity for NeuroBio to grow as it advances its “promising pipeline” for neurodegenerative diseases.
“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 US 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,” he said.
NB-01 is an oral drug candidate for painful diabetic neuropathy (PDN). In a randomised, 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 enrolment in the first Phase 3 study with NB-01 is anticipated in the first half of 2020 and will enrol approximately 460 subjects with PDN across the US.
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.