NeuroBo Pharmaceuticals, a Boston-based clinical-stage pharma company, has wrapped up its previously announced merger with Gemphire Therapeutics, a Michigan-based clinical-stage biopharma company focused on developing therapies for dyslipidemia and nonalcoholic fatty liver disease (NASH).
The new combined company will be called NeuroBo Pharmaceuticals, which will focus on advancing a clinical-stage pipeline targeting neurodegenerative diseases.
NeuroBo, Gemphire merger was announced in July 2019.
Richard J. Kang – president and CEO of the enlarged NeuroBo Pharmaceuticals, commenting on the NeuroBo, Gemphire merger, said: “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.”
NeuroBo Pharmaceuticals is set to screen patients in the US shortly for the first study in the phase 3 program for its lead drug candidate, NB-01, for painful diabetic neuropathy (PDN). The biopharma company will also be working on a first-in-human trial for NB-02, a compound targeted at Alzheimer’s disease and diseases associated with the pathological dysfunction of tau proteins present in the brain.
NB-01, during a randomized, placebo-controlled phase 2 clinical trial, achieved significant improvement in pain scores from baseline as measured by the NRS. It is also said to have presented an excellent safety profile in comparison to retrospective safety data on existing therapies.
NeuroBo Pharmaceuticals expects to launch enrollment in the first phase 3 study for NB-01 in the first half of this year. The Boston pharma company will enroll nearly 460 patients across the US who are having painful diabetic neuropathy.
NB-01 was licensed by NeuroBo Pharmaceuticals from Dong-A ST, a Korean pharmaceutical company.
On the other hand, NB-02, in preclinical animal disease model studies showed evidence of efficacy and safety in neurodegeneration.
NeuroBo Pharmaceuticals also intends to continue the advancement of gemcabene, which has been in development by Gemphire Therapeutics for dyslipidemia treatment.
Gemcabene has been studied in 1,100 plus human subjects in a total of 25 Phase 1 and Phase 2 trials, where it showed efficacy and safety.
NeuroBo Pharmaceuticals is looking to submit an application with results of a preclinical mouse safety study to the US Food and Drug Administration (FDA) in early 2020 to resolve a partial clinical hold pertaining to gemcabene’s activation of peroxisome proliferation-activated receptor (PPAR). If approved, the dyslipidemia drug candidate will be ready to advance into phase 3 human studies.
The combined biopharma company will also continue to support the partnership with Beijing SL Pharmaceutical for the rights of gemcabene in China.
Following the closing of the NeuroBo, Gemphire merger, shareholders of NeuroBo Pharmaceuticals own 96.24% in the combined entity, while Gemphire’s stockholders hold the remaining stake of 3.76%.