Tetra Pharm Technologies advances CB1 antagonist, TPT0701, for appetite suppression into preclinical testing

The Danish biopharmaceutical company, Tetra Pharm Technologies, proudly announces a significant milestone in the realm of appetite suppression research having developed a cutting-edge compound leveraging their innovative platform technology.

COPENHAGEN, Denmark, Feb. 8, 2024 -- Following the successful filing of Intellectual Property (IP) for their applied platform technology targeting the endocannabinoid system (ECS), Tetra Pharm Technologies, is moving forward with its compound for appetite suppression, TPT0701.

Endocannabinoid system modulation has long been recognized as a promising avenue for appetite regulation. Through rigorous research and development efforts, Tetra Pharm Technologies has unlocked the potential of this biological system to address one of the most pressing health challenges of our time – excessive appetite and weight gain.

TPT0701 was originally designed in 2022 for obese patients suffering from schizophrenia but will now move into the development stage as appetite suppressing medication for general weight loss.

Dr. Morten Allesø, Chief Scientific Officer, Tetra Pharm Technologies, said: "With our new, proprietary platform technology as our secret weapon to unlock the endless possibilities of the endocannabinoid system, we are now ready to finalize TPT0701 for pre-clinical testing in 2024".

"Compounds, such as TPT0701, display physicochemical properties that render them difficult to formulate by means of conventional approaches. Our enabling platform technology, now with an IP application supporting it, can accommodate exactly these types of molecules and will help overcome otherwise hampering drug delivery challenges such as poor absorption and ultimately low bioavailability. Indeed, a drug is only as good as its delivery system, and with a check mark secured on both the formulation technology and the pharmacological mode of action established in early drug discovery, we are confident in the ongoing success of TPT0701 as it progresses through development," added Morten Allesø.

TPT0701 offers a novel approach to appetite suppression, aiming to provide individuals with a safe and effective means to manage their cravings and achieve their wellness goals. By specifically targeting the endocannabinoid system, Tetra Pharm Technologies' solution holds promise for combating obesity and related metabolic disorders, with far-reaching implications for public health.

"Obesity and its associated health risks have reached alarming levels worldwide, necessitating innovative approaches to address this pressing issue. Research and development are our top priority, and we will continue to invest in building our pipeline of new drug candidates targeting the endocannabinoid system and related disease indications", says Martin Rose, Chief Executive Officer, Tetra Pharm Technologies... Tetra Pharm Technologies' Press Release -

Scholar Rock Announces FDA Clearance of IND Application to Initiate Phase 2 Proof-of-Concept Trial with Apitegromab to Treat Obesity

• Randomized Phase 2 proof-of-concept trial with apitegromab in patients with obesity on GLP-1 therapies on track to initiate mid-2024
• Study aims to show the importance of selective myostatin inhibition in preservation of lean muscle mass as part of healthy, safe weight loss management
• Scholar Rock is also developing SRK-439, a novel investigational selective myostatin inhibitor, optimized for the treatment of obesity

CAMBRIDGE, Mass.--Jan. 23, 2024-- Scholar Rock (NASDAQ: SRRK) (the Company), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its Phase 2 proof-of-concept trial of apitegromab to treat obesity in patients taking a GLP-1 receptor agonist (GLP-1 RA).

The Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the effect of apitegromab, a highly selective myostatin inhibitor, to safely preserve lean muscle mass as an adjunctive therapy in overweight and obese adults who are taking a GLP-1 RA. Trial initiation is on track for mid-2024, and data from the apitegromab Phase 2 trial are expected in mid-2025. In parallel, Scholar Rock is developing SRK-439, a novel investigational selective myostatin inhibitor, optimized for the treatment of obesity. The Company plans to file an IND for SRK-439 in 2025.

“The FDA’s acceptance of our IND application to study apitegromab in obesity allows us to assess the effect of our highly selective myostatin inhibitor on preserving lean muscle mass, and safety and tolerability of our approach when combined with a GLP-1 RA. The IND builds on our encouraging apitegromab clinical and safety data to date and allows us to inform the development of our cardiometabolic program with SRK-439, a novel preclinical selective myostatin inhibitor optimized for development in cardiometabolic disorders,” said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock. “Maintaining lean mass during weight loss is important to overall metabolic health, and we look forward to initiating the Phase 2 proof-of-concept trial in apitegromab to validate our differentiated approach of selectively targeting only the pro- and latent forms of myostatin to retain muscle mass.”... Scholar Rock's Press Release -