Biotech Values

[hptaxis]

VK5211 Fail ... The [scant] data presented indicate failure. They will pump this for all they can [and more]. I call it the Podolski Pump.

The obvious hurdle is the connection to AAS. Approval will need to pass increased scrutiny. There are 1000s, no 100,000s, of UGL AAS users wishing for approval.

GTx also had a cachexia trial that failed to progress. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4898053/

LBM will not be an FDA approvable endpoint. As you probably know, there will need to be an approved PRO, thus the 6MW test. They state their trial was not powered for significance on this endpoint. LMAO!

But, kudos to them for showing the anabolic response was lost 12 weeks after stopping the SARM. IOW, AIH [Androgen Induced Hypogonadism]. It would be of interest to see the hormone levels, male/female breakdown, fracture details, lipids, SHBG, ... They will need to be produced to the FDA for approval should it ever get that far. The SARM is a bust.


• Patients receiving VK5211 demonstrated dose-dependent improvements in the 6-minute walk distance as compared to placebo, though this exploratory endpoint was not powered for significance. For patients in the 2.0 mg VK5211 treatment arm, the mean distance increased by approximately 22 meters compared to placebo.

• Patients were also assessed 12 weeks after completion of the study to evaluate safety and efficacy at 24 weeks. At this 24-week timepoint, the increases in total lean body mass, less head, for all VK5211 treatment arms remained above placebo, though the increases were no longer statistically significant. The durable increases in muscle mass that were maintained three months following the last dose of VK5211 highlight the potent treatment effect VK5211 demonstrated in these patients.

Finally, we are pleased with the safety and tolerability of VK5211 in this study, with no drug-related serious adverse events observed and no clinically meaningful changes in important markers such as hemoglobin, red blood cell counts and coagulation factors." [Safety does NOT include lipids. Right! And, others below.]


Some additional info that might be of interest.


Schroeder ET, Zheng L, Yarasheski KE, et al. Treatment with oxandrolone and the durability of effects in older men. Journal of Applied Physiology 2004;96(3):1055-62. https://www.physiology.org/doi/full/10.1152/japplphysiol.00808.2003

We investigated the effects of the anabolic androgen, oxandrolone, on lean body mass (LBM), muscle size, fat, and maximum voluntary muscle strength, and we determined the durability of effects after treatment was stopped.

Twelve weeks after oxandrolone was discontinued (week 24), the increments in LBM and muscle strength were no longer different from baseline (P> 0.15). However, the decreases in total and trunk fat were sustained (-1.5 ± 1.8, P= 0.001 and -1.0 ± 1.1 kg, P < 0.001, respectively).

Thus oxandrolone induced short-term improvements in LBM, muscle area, and strength, while reducing whole body and trunk adiposity. Anabolic improvements were lost 12 wk after discontinuing oxandrolone, whereas improvements in fat mass were largely sustained.


Basaria S, Collins L, Dillon EL, et al. The Safety, Pharmacokinetics, and Effects of LGD-4033, a Novel Nonsteroidal Oral, Selective Androgen Receptor Modulator, in Healthy Young Men. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. https://academic.oup.com/biomedgerontology/article/68/1/87/548321

LGD-4033 administration was associated with dose-dependent suppression of total testosterone, sex hormone–binding globulin, high density lipoprotein cholesterol, and triglyceride levels. Follicle-stimulating hormone and free testosterone showed significant suppression at 1.0-mg dose only. Lean body mass increased dose dependently, but fat mass did not change significantly. Hormone levels and lipids returned to baseline after treatment discontinuation.

• Muscle Performance and Physical Function - The increase in strength averaged 68.3 N at the 1.0-mg dose, but this change was not significantly different from that in the placebo group. Stair-climbing speed and power revealed a trend toward dose-related improvement, but these changes did not achieve statistical significance.