NeuroBo Pharmaceuticals Announces Exclusive License Agreement with MThera Pharma for NB-01

Rhea-AI Summary

NeuroBo Pharmaceuticals (Nasdaq: NRBO) has signed an exclusive license agreement with MThera Pharma for NB-01, a potential treatment for painful diabetic neuropathy. The agreement grants MThera rights to conduct research and clinical trials, including a possible Phase 3 trial in the US and South Korea. This move aligns with NeuroBo's strategy to out-license legacy assets and focus on developing DA-1726 and DA-1241.

MThera, with its expertise in natural medicines and botanical drugs, plans to utilize its SyMthomics platform to identify NB-01's mechanism of action and active ingredients. This approach aims to predict clinical efficacy and advance NB-01 into further clinical development, building on its positive Phase 2 results for diabetic neuropathy.

Positive

• Exclusive license agreement signed for NB-01, potentially advancing its development
• Alignment with NeuroBo's strategy to focus on core assets DA-1726 and DA-1241
• Positive Phase 2 efficacy results for NB-01 in diabetic neuropathy
• Potential for Phase 3 clinical trial in the US and South Korea

Negative

• Financial terms of the agreement not disclosed
• Out-licensing of NB-01 may reduce potential future revenue streams for NeuroBo

Insights

Biotechnology Analyst

This exclusive licensing agreement between NeuroBo Pharmaceuticals and MThera Pharma for NB-01 is a strategic move that could have significant implications for both companies and the treatment of painful diabetic neuropathy.

The deal allows NeuroBo to streamline its focus on its core assets, DA-1726 and DA-1241, while potentially benefiting from future development of NB-01. This aligns with the company's stated strategy of out-licensing legacy assets, which could improve its financial position and resource allocation.

For MThera, acquiring rights to NB-01 expands their pipeline with a promising Phase 2 asset in the lucrative diabetic neuropathy market. Their expertise in natural medicines and botanical drugs, coupled with their SyMthomics platform, could potentially accelerate NB-01's development and increase its chances of success in Phase 3 trials.

However, investors should note that financial terms were not disclosed, making it difficult to assess the immediate impact on NeuroBo's balance sheet. The long-term value of this deal will depend on NB-01's performance in future clinical trials and its eventual commercialization prospects.

Overall, this agreement represents a calculated risk for both parties. If successful, it could lead to a valuable treatment option for diabetic neuropathy patients and significant returns for both companies. However, as with any drug development process, there are substantial risks and uncertainties ahead.

Medical Research Analyst

The licensing of NB-01 to MThera Pharma marks an interesting development in the field of diabetic neuropathy treatment. The positive Phase 2 efficacy results mentioned in the article are encouraging, but it's important to remember that many drugs fail in Phase 3 trials despite promising earlier results.

MThera's SyMthomics platform technology could be a game-changer in this context. By identifying the mechanism of action and active ingredients of NB-01, they may be able to optimize the drug's formulation or better predict its efficacy in larger patient populations. This could potentially increase the chances of success in Phase 3 trials.

However, it's important to note that botanical drugs often face unique challenges in regulatory approval processes. The FDA typically requires more extensive characterization and standardization for these products compared to synthetic drugs. MThera's experience in this area could be important in navigating these regulatory hurdles.

From a medical perspective, a new treatment for painful diabetic neuropathy would be welcome. Current treatments often have efficacy or significant side effects. If NB-01 can demonstrate a superior efficacy or safety profile in Phase 3 trials, it could potentially capture a significant market share.

Investors should keep a close eye on any announcements regarding the initiation of Phase 3 trials and their design, as these will be critical in determining the future prospects of NB-01.

CAMBRIDGE, Mass., July 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the signing of an exclusive license agreement, providing MThera Pharma Co., Ltd. (MTHERA) with the rights to NB-01 for the treatment of painful diabetic neuropathy. The agreement allows MTHERA to conduct research and clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States and South Korea, for the future commercialization of NB-01. Financial terms of the agreement were not disclosed.

"Finalizing this agreement for NB-01 is an important milestone for NeuroBo, reflecting our stated commitment to out-license our legacy assets in order to focus on the continued clinical development of DA-1726 and DA-1241," stated Hyung Heon Kim, President and Chief Executive Officer of NeuroBo. "MTHERA has extensive experience in manufacturing, quality control and clinical development of natural medicines and botanical drugs, making the company an ideal partner to continue the development of NB-01."

"Based on the positive Phase 2 efficacy results for NB-01 for diabetic neuropathy, we intend to develop it as a potential treatment for peripheral diabetes," stated Dr. Mi Won Sohn, Chief Executive Officer of MTHERA. "Utilizing our SyMthomics platform technology, we can clearly identify the mechanism of action and active ingredients of NB-01 to assist in predicting its clinical efficacy as an innovative treatment, with the intent of advancing NB-01 into the next phase of clinical development. We are grateful to NeuroBo for the opportunity to further advance NB-01, and to potentially bring this promising therapy to patients in need."

About MThera Pharma
MThera Pharma Co., Ltd., headquartered in Seoul, South Korea, is a biopharmaceutical company developing first-in-class botanical drug products using novel, multi-component/multi-target-driven disease-modifying therapies to address diverse etiology and treat chronic incurable diseases such as Parkinson's disease, dementia and inflammatory bowel disease. MThera's platform technology, SyMthomics, consists of its MThera-CODA system (AI based in silico system), a cutting-edge multi-omics integration technology, as well as systems biology and bioinformatics. MThera's standardization technology and advanced CMC technology for raw materials, drug substances and drug products are designed to meet the U.S. Food and Drug Administration requirements for therapeutic consistency. For more information, please visit www.mtherapharma.com.

About NeuroBo Pharmaceuticals
NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control.

For more information, please visit www.neurobopharma.com.

Forward Looking Statements
Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; potential negative interactions between NeuroBo's product candidates and any other products with which they are combined for treatment; NeuroBo's ability to initiate and complete clinical trials on a timely basis; NeuroBo's ability to recruit subjects for its clinical trials; whether NeuroBo receives results from NeuroBo's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the Securities and Exchange Commission, including NeuroBo's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

NeuroBo Pharmaceuticals 
Marshall H. Woodworth 
Chief Financial Officer
+1-857-299-1033
marshall.woodworth@neurobopharma.com

Rx Communications Group 
Michael Miller 
+1 917-633-6086
mmiller@rxir.com 

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SOURCE NeuroBo Pharmaceuticals, Inc.

FAQ

What is the purpose of NeuroBo Pharmaceuticals' license agreement with MThera Pharma for NB-01?

The exclusive license agreement allows MThera Pharma to conduct research and clinical trials, including a potential Phase 3 trial, for NB-01 in the treatment of painful diabetic neuropathy, with the aim of future commercialization.

What were the results of NB-01's Phase 2 trial for diabetic neuropathy?

The press release mentions positive Phase 2 efficacy results for NB-01 in diabetic neuropathy, which has prompted MThera to pursue further development of the drug.

How does the NB-01 license agreement align with NeuroBo Pharmaceuticals' (NRBO) strategy?

The agreement aligns with NeuroBo's strategy to out-license legacy assets, allowing the company to focus on the clinical development of its core assets, DA-1726 and DA-1241.

What technology will MThera use to develop NB-01 further?

MThera plans to use its SyMthomics platform technology to identify NB-01's mechanism of action and active ingredients, aiming to predict its clinical efficacy and advance it to the next phase of clinical development.