TechnoDerma Medicines new small molecule - TDM-105795

edh38

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"Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing in its Phase 1b (MAD) clinical trial of topical TDM-105795 solution in patients with Androgenetic Alopecia (Androgenetic Alopecia). This second clinical trial in the program is a 28-day multiple dose escalation study entitled, “A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group, Multi-Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TDM-105795 in Healthy Male Subjects with Androgenetic Alopecia”. Study objectives are to evaluate the safety and pharmacokinetics of topical TDM-105795 following repeated doses. Two U.S. clinical sites are currently participating in this study.



Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We also expect the current study results to guide choice of formulation strength(s) appropriate for a subsequent proof-of-concept (PoC) Phase 2 Androgenetic Alopecia study. The Company anticipates the robust induction of hair growth demonstrated by TDM-105795 in preclinical testing should be observable within several months of initiating treatment.”



“We look to the TDM-105795 Androgenetic Alopecia program as the first clinical anchor among our pipeline products for treatment of various dermatologic diseases,” said Zengquan Wang, Chief Executive Officer at Technoderma Medicines. “We are working tobring a second pipeline product (Atopic Dermatitis) into clinical testing soon in mid-year.”

 

LoWS

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Techno derma says its product stimulates dormant follicles and had seen robust regrowth in phase 1 , started phase 1B and will be completed by October.
Credit: Follicle Thought
 

Pigeon

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Is this something the discord guys can trial? Edit: seems they're already ordering lol
 

fashy

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Techno derma says its product stimulates dormant follicles and had seen robust regrowth in phase 1 , started phase 1B and will be completed by October.
Credit: Follicle Thought

Where does it say they observed robust regrowth in phase I? Can only see them mentioning regrowth in the mice studies.
 

Ralph Wiggum

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pegasus2

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"The Company anticipates the robust induction of hair growth demonstrated by TDM-105795 in preclinical testing should be observable within several months of initiating treatment.”

They're doing phase I over again? So they didn't get the expected results the first time I presume
 

pegasus2

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Is that what phase 1b means? Just doing phase 1 over?
Yes, doing it again with what you've learned from the first time. Probably they learned the doses they were using are too low. I doubt the higher doses work much/any better.
 

edh38

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Yes, doing it again with what you've learned from the first time. Probably they learned the doses they were using are too low. I doubt the higher doses work much/any better.
this is more than standard - phase 1 costs are approx. 1/10 of phase 2+ phase 3 costs so if you can go higher from a safety pov and prior research suggests it is beneficial, you would do it..
 

pegasus2

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this is more than standard - phase 1 costs are approx. 1/10 of phase 2+ phase 3 costs so if you can go higher from a safety pov and prior research suggests it is beneficial, you would do it..
The goal is to get a product on market, so if you don't need to run another phase 1 you don't
 

Roeysdomi

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Yes, doing it again with what you've learned from the first time. Probably they learned the doses they were using are too low. I doubt the higher doses work much/any better.
Why you think higher wont work?
 

pegasus2

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Why you think higher wont work?
Because the mechanism of action doesn't address the reduced number of progenitor cells, it only allows you to do more with what you have.
 

Roeysdomi

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Because the mechanism of action doesn't address the reduced number of progenitor cells, it only allows you to do more with what you have.
So its like minoxidil? Works untill the male pattern baldness overcome it effect?
 

pegasus2

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edh38

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The goal is to get a product on market, so if you don't need to run another phase 1 you don't
Or the goal is to get the most bang for your buck..semantics not worth talking about, much less as an argument.
Just fyi- a 1b following a 1a is the norm.

The 1a consisted of groups which received tdm once, whereby the tdm concentration per group varied.
called Single-Ascending-Dose (SAD) study. This new 1b is a multiple ascending dose (MAD) study - same as above, but each group receives tdm multiple times. In other words - they probably dont know if it even works just based on the 1a.
 

pegasus2

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Or the goal is to get the most bang for your buck..semantics not worth talking about, much less as an argument.
Just fyi- a 1b following a 1a is the norm.

The 1a consisted of groups which received tdm once, whereby the tdm concentration per group varied.
called Single-Ascending-Dose (SAD) study. This new 1b is a multiple ascending dose (MAD) study - same as above, but each group receives tdm multiple times. In other words - they probably dont know if it even works just based on the 1a.
It's actually not the norm, but I understand it's not unusual. If you were on discord you would know my skepticism has nothing to do so this second phase 1. I don't believe in the moa so I don't follow this company. I'm not familiar with the structure of their trials. If their 1a was indeed a SAD study then running another phase 1 is not a negative indication. I still don't believe the drug can surpass minoxidil
 

volinets0

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New chemical and we know the chemical structure, yet there's not yet a GB and an associated discord sever.......!?! :)

I jest, but I probably would give it a go. Desperate times

Thank you OP for the good work
What is gb? I have come across the acronym several times on this website, but have never understood what it means
 
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