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Dragon SPAC and Jaguar Napo EU subsidiary submit required notification to Italian government to support completion of merger

Results accepted for phase 2 HALT-D study initiated by third-party investigator evaluating crofelemer for the prevention and prophylaxis of diarrhea in breast cancer patients as poster for the December 2021 Symposium about San Antonio breast cancer

Jaguar Health, Inc. (NASDAQ: JAGX) today provided updates regarding ongoing research and development related to the company’s crofelemer product candidates, and also announced that Dragon SPAC SpA and Napo EU SpA, the Italian subsidiary of the company, have submitted the required notification in order to approve the impending merger of Dragon SPAC and Napo EU, as required by Italian law.

“We know that shareholders and other stakeholders have been eagerly awaiting the completion of the merger between Dragon SPAC and Napo EU. The requirement of this complex regulatory case with the Italian government is a new regulation enacted during COVID that applies to transactions involving pharmaceutical assets in Italy with foreign participation, ”said Lisa Conte, President and CEO of Jaguar and member of the board of directors of Napo EU. “We are delighted to have completed the submission of this notification and look forward to expanding the Napo EU team to the Italian region of Lombardy – the leading Italian region in the field of life sciences – in support of the ‘objective to develop and market crofelemer throughout Europe for patients in need. “

Napo EU & Dragon SPAC: Short bowel syndrome with intestinal insufficiency

Napo EU was formed with a mission to expand access to crofelemer in Europe to address the significant unmet gastrointestinal medical needs in the region. Napo EU’s initial goal is to continue the European Medicines Agency (EMA) conditional marketing authorization path for crofelemer in short bowel syndrome with intestinal insufficiency (SBS-IF) , an orphan disease. As announced on September 15, 2021, the EMA has confirmed receipt of the application for an orphan drug designation for crofelemer submitted by Napo EU. Crofelemer has previously received an orphan drug designation from the US Food and Drug Administration (FDA) for SBS.

“After the completion of the merger of Napo EU and Dragon SPAC, Napo EU will contribute to the combined entity its exclusive license agreement with Jaguar for the crofelemer / lechlemer pipeline, and Dragon SPAC will contribute to the financing,” said Conte.

Diarrhea related to cancer treatment

Investigators in the Phase 2 Cancer Treatment-Related Diarrhea (CTD) in Patients With Breast Cancer Study (the HALT-D study) have been told that the results poster for the study had been accepted for presentation at the San Antonio Breast Cancer Symposium. in December 2021. More specifically, the effects of crofelemer on diarrhea associated with targeted treatment regimens containing trastuzumab, pertuzumab, docetaxel or paclitaxel and / or carboplatin were evaluated in this study.

As previously announced, the HALT-D study was sponsored by Georgetown University and funded by Genentech, a member of the Roche group, and is completely independent from the ongoing pivotal phase 3 clinical trial on crofelemer for the Prophylaxis of diarrhea in adult cancer patients receiving targeted therapy initiated in October 2020 by Jaguar. Recruitment for the phase 3 trial on crofelemer is underway. As previously announced, the financing of this development program was provided by non-dilutive financing transactions involving the sale of royalty rights related to the company’s future Mytesi. (crofelemer) and lechlemer revenue streams.

Discussion with the FDA in September 2021 regarding the planned study of NP-300 (Lechlemer) for the symptomatic relief of diarrhea due to acute infections such as cholera

Members of Jaguar’s clinical development team corresponded with the U.S. Food and Drug Administration (FDA) on a Pre-Investigational Counseling Program (Pre-IND) last month. The written correspondence was satisfactory regarding the company’s plan to file an IND for NP-300 and initiate a Phase 1 trial in the second half of 2022 for the evaluation of NP-300 for symptomatic relief of pain. diarrhea caused by acute infections such as cholera. , and therefore a meeting in September was not necessary.

NP-300 is a standardized and proprietary botanical pharmaceutical product that is sustainably derived from the Lechleri ​​croton tree. This program is matched with funding from a promissory note tied to the potential future sale of a possible tropical disease priority review voucher. Priority Review Vouchers are granted by the FDA as an incentive to develop treatments for neglected diseases and rare diseases and are transferable.

Canaleviaâ„¢, Jaguar’s oral herbal prescription medicine for the treatment of chemotherapy-induced diarrhea in dogs

As announced on September 23, 2021, Jaguar was informed by the FDA’s Center for Veterinary Medicine that the Target Animal Safety technical section of Canalevia’s conditional approval application for chemotherapy-induced diarrhea (CID) under Minor Use and Minor Species (UMMS) The Animal Health Act was deemed “Completed”. With the completion of the TAS section – the last of the four major technical sections of the Jaguar app – Jaguar plans to launch Canalevia for CID in dogs in December 2021.