"Rationale" “RATIONALE
The addition of the Product to the Company’s pipeline will further enrich our innovative pipeline, complete our layout in field of NASH and provide better treatment for NASH patients in China. NASH is an area of high unmet medical need with no approved treatments currently available and one of the fastest growing causes of liver cirrhosis and liver cancer globally. Currently there is no approved treatment in China, and therefore by 2025, the new incidence of NASH in China is expected to reach 2 million every year. The Product is a late stage asset currently in Phase III clinical trials in the US, thereby it is expected to be the first FDA approved oral NASH treatment with potentially best in class efficacy, to address a large clinical unmet need in the global NASH market.”
https://www.sinobiopharm.com/userfiles/files/E22092696-Sino%20Bio-PA.pdf
From qwerty’s post:
“Depending on multiple factors, including Chinese regulatory authority feedback, CTTQ will either join the ongoing NATiV3 Phase III clinical trial of lanifibranor in NASH or run an independent study. CTTQ will bear all costs associated with the trials conducted in Greater China.”
Again the condition is a growing unmet global issue both in terms of health and financial burden to the healthcare systems, this collaboration is financial but also the Chinese might add their resources to the trial(co-development) or ran their own study motivated by their “rational”.
Looking into the current regulations there were some initiatives to harmonize clinical trials such as Multi Regional Clinical Trials:
“MRCTs can facilitate simultaneous global development of a drug and reduce the number of clinical studies conducted separately in each region, thereby minimizing unnecessary duplication of studies. Although MRCTs require more coordination during the planning stage and possibly increase start-up time, their use may provide a pathway for earlier access to new drugs worldwide by facilitating earlier approval across regions, thereby avoiding significant lag in the availability of new drugs in some regions.”
E17EWG_Step4_2017_1116.pdf (ich.org)
Another interesting regulation is the use of Real World Evidence/Data typically used for post marketing trials but also INDs/NDAs both for clinical trials and observational studies which could be potentially relevant! For instance the current ongoing observational study “The Visceral Adiposity Measurement and Observation Study” could generate RWD among others the positive correlation between excessive visceral fat and coronary heart disease in PLWH and that data can potentially lead to IND/NDA and even an expanded label for a drug targeting/reducing ectopic fat(Tesamorelin).
“This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) that contain RWD/RWE intended to support a regulatory decision regarding product safety and/or effectiveness. RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated from RWD using many different study designs, including but not limited to, interventional studies (clinical trials) or non-interventional (observational) studies.”
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
As for recent posts (specifically for THTX which did not post anything related to cancer for a long time/the usual characteristic radio silence) including the below with this statement:
“Together we are committed to making a difference in lives of people affected by cancer”.
To me it is encouraging considering the timing of them and after a quiet period, wishful thinking or “rationale” assumption??
Theratechnologies Inc. on LinkedIn: #runforthecure #courselavie