Jaguar Health Inc. (NASDAQ:JAGX) has announced that its wholly-owned subsidiary, Napo Pharmaceuticals Inc., has commenced a vital third phase crofelemer (Mytesi®) study, The trial is evaluating crofelemer in treating diarrhoea prophylaxis in adult cancer patients that are receiving targeted therapy.
Napo Pharmaceuticals commences Phase 3 study of Crofelemer
The phase 3 clinical study will be a 24-week study in two stages of 12 weeks. It will be a double-blind, placebo-controlled, randomized study evaluating the efficacy and safety of crofelemer in offering prophylaxis of diarrhoea in solid tumor cancer patients under targeted cancer therapy with treatment regimens. After completing the first stage of the treatment phase, the study participants can remain in their treatment arm or enter into stage two of the extension phase.
The efficacy and safety of oral crofelemer will be asses for prophylaxis of diarrhoea in adult cancer patients under targeted cancer therapy with or without chemotherapy regimens. The diarrhoea assessment frequency will be considered by the number of watery or/and loose stools for treatment in Stage I. Jaguar Health Chair Pravin Chaturvedi said the trial’s initiation is a huge milestone for crofelemer as a potential treatment for mitigating and/or preventing the severity and intensity of diarrhoea in cancer patients under targeted cancer therapy.
Jaguar enters agreement for the sale of crofelemer royalty rights
Recently Jaguar Health entered a deal with a secured lender for non-dilutive royalty financing transactions. According to the agreement, the company will sell royalty interests to the lender for an aggregate price of $5 million. The lender will be entitled to 2X the royalty purchase price on crofelemer sales royalties in the future and some upfront license fees and milestone payments from distributors and licensees. Upon mutual agreement, the parties may decide to consummate more royalty financings of around $5 million and $6 million in February and July 2021, respectively, for around $16 mm.
The company plans to use the proceeds from the financing to support regulatory activities related to its development pipeline. This includes funding of crofelemer (Mytesi) trials for cancer therapy-related diarrhoea, which will begin Q4 2020.
