RE:RE:RE:Article from Bloomberg of note
Wino115 wrote: Would make sense just to partner on rights for that indication and carve it out from others. Or use it to attract someone on the whold obesity + NASH potential. For not much, you could get a lot given the situation. They need to be creative.
jfm1330 wrote: Egrifta (tesamorelin) an analog of GRF (1-44) could be very efficacious a fat burning drug in obese people. It was the initial use that was thought about for GRF family of peptides, but 30 years ago there was fear of GRF promoting cancer. Now with the safety track record of Egrifta, I wonder why this is not considered again for obesity.
Also, important to note that Wegovy is in reality a long acting formulation of semaglutide, an analog of the natural peptide GLP-1. The once a week injection is made with a single use pen that allows subcutaneous injection of the drug.
Semaglutide is a 31 amino acids peptide and NovoNordisk were able to formulate it as a once a week injection. The dose (2.4 mg/week in 0.25 ml) is much lower than the dose of Egrifta (1,4 mg/day in 0.25 ml) so 9.4 mg/week in 1.75 ml. But F8 will allow volume of injection of 0.18 ml per day, so 1.26 ml injected per week. All that to say that if Thera would partner in NASH with a big pharma, development of a once a week injection could be possible and maybe obesity could be a second application.
Novo Nordisk even developped an oral formulation of semaglutide for diabetes type 2 (Rybelsus) that can be taken instead of the injection formulation (Ozempic). In the case of the oral formulation, the dose of the peptide that is ingested is much higherthan the injected one since a large part of the dose will be digested before making it to the bloodstream. But it shows that formulation of peptides with large markets by big pharmas is improving a lot, and it gives new patent protection extending the high profitability of these drugs. The first commercial formulation of semaglutide was a twice a day injection for type 2 diabetes. It shows how much they improved it since then.
The problem of Egrifta is that it was not approved for a large market like type 2 diabetes, but for a very small market, HIV lipodystrophy. All that to say that a big pharma taking tesamorelin could extend patent protection until at least 2050 with advanced formulations like once a week, which would justify investing in the phase II/III in NASH with the option to stop everything after the phase II part.
For a big pharma it would not be such a big investment, given the possible reward. It would cost an upfront payment to Thera at signing, and the cost of a a clinical trial on 300 patients. Only if results are good would they have to pay for the whole trial and pay milestones and a royalty rate on sales if approved. And you now have a door open in obesity down the line if it's approved in NASH.
SPCEO1 wrote: At a different job 25 years ago, I spent months reporting on a diet drug combo called fen-phen. At the time, drugmakers were eager to come up with patented drugs that could duplicate the success of fen-phen. Then one of the drugs in the combo was linked to heart disease and deaths and it all came crashing down.
For a long time, obesity drug development was out of favor as Big Pharma focused on other lucrative arenas such as cancer. Now obesity medicines are making a roaring comeback, thanks to a new class of diabetes drugs that also turn out to be surprisingly potent weight loss agents. And at the JPMorgan Healthcare Conference last week, obesity medicines were a major focus, as I reported with
my colleague Emma Court.
Companies including Eli Lilly and Pfizer are trying to match the success of Novo Nordisk, the maker of the highly effective Wegovy injection that mimics a weight-related hormone called GLP-1. Amgen was also among companies presenting at the conference with a potential obesity entrant. The companies are aiming to bring to market weight loss drugs targeting the same pathway that either melt off even more pounds, have less frequent dosing or don’t require injection.
“This is the beginning of a whole new therapeutic area,” Eli Lilly Chief Scientific Officer Daniel Skovronsky told me at the meeting. The new drugs mimic the effects of natural hormones called incretins that are secreted from the gastrointestinal tract and tell the body food has been eaten.
Lilly’s drug, called tirzepatide, helped people lose more than 20% of their weight in one big trial last year, with a second big trial slated to finish this year. Meanwhile, in an early trial, patients on the highest dose of Amgen’s AMG 133 saw an average loss of 14.5% of their weight after just 12 weeks of treatment, according to results released in December. Like Novo’s medicine, Amgen’s drug and Lilly’s tirzepatide are injectable.
Covid vaccine juggernaut Pfizer is working on two drugs that hit the GLP-1 pathway that can be given as pills. It thinks that in the obesity market, the convenience of pills may be a key competitive advantage. At a fireside chat at the meeting, Pfizer CEO Albert Bourla said he thought the overall market for the class of medicines could grow to $90 billion a year, including both the obesity and diabetes uses combined. His company might capture $10 billion of that, he said.
To achieve those big numbers, though, a lot still has to happen. Final stage trials will have to show the various potential entrants are as safe and effective, as they at least appear to be so far. Companies will have to consistently produce the medicines. Supply issues limited Novo Nordisk’s Wegovy last year, although the company says the shortage has been resolved with all doses available for order since the end of last year.
But the biggest question mark of all is whether drugmakers can convince insurance companies to cover the new medicines. Spotty coverage has been a long-standing problem for obesity drugs. In a couple years, as more trial results roll in and more of the drugs hit the market, we should get a much better sense of how how big this new class will turn out to be. —
Robert Langreth
I agree the company needs to present Tesamorelin as a drug with multiple therapeutic benefits which can potentially each target sizeable market opportunity.
MGH did a study looking art abdominal fat in obese patients ( BMI equal or higher the 30 kg/m2)treated by Tesamorelin.
From the description:
“Obesity, defined as having a high amount of excess body fat, is one of the most wide-spread health problems of today. A variety of factors can lead to obesity. These factors include physical inactivity, family history and genetics, metabolism, and hormone imbalance. The excess body fat in obesity increases a person's risk of a number of life-threatening diseases, including heart disease, gall stones, type 2 diabetes, and certain types of cancer. People with abdominal obesity, where fat is stored predominantly around a person's midsection, are particularly prone to weight-related diseases. Studies have shown that administration of growth hormone to obese people reduces abdominal fat, but can be associated with adverse side effects. GHRH is a natural hypothalamic peptide that stimulates growth hormone release. GHRH may be able to normalize growth hormone levels, reduce abdominal fat, and lessen risk for cardiovascular disease in people who are obese, without the associated side effects of growth hormone administration.”
As per results the drug not only reduced the abdominal fat, but also reduced carotid intima-media thickness( less build up of fat plaque) less chance for stroke, reduced the low density cholesterol(bad cholesterol which can cause heart diseases) reduced triglycerides, again causing heat diseases /stroke etc. So the drug’s therapeutic potentials looks promising dealing with obesity and also many metabolic diseases among obese people.
First link is the trial, second one its results.
A potential partner for NASH market value 35 plus billions can explore the drugs potentials for that obesity market valued 10 billion both conditions have growing prevalence and cost the healthcares world wide….
https://clinicaltrials.gov/ct2/show/NCT00675506
Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese - Study Results - ClinicalTrials.gov