There aren’t a lot of details about the study available yet however the article announces that the study was conducted in mice aged 19 months, a similar age to the mice tested in the rapamycin ITP trial of mice treated in late life with rapamycin.
On twitter a few days ago someone shared data which they claim is from the MyMD-1 longevity trial
It’s not clear to me that this data is 100% reliable as it’s coming from a source that’s to my knowledge unofficial, however I wanted to entertain that it may actual data from the trial for the purpose of this post.
One thing I found concerning here is that the rapamycin arms aren’t living very long. For example, the median lifespan of the rapamycin controls here is only 850 or so days and the maximal lifespans for both rapamycin mice are less than 1000 days. In the ITP study of rapamycin which initiated treatment at 19-20 months, both the control and rapamycin mice lived longer in median and maximal lifespan than the rapamycin fed mice in the data linked above. Perhaps the issue is simply that the mice used in the MyMD study are not as long lived. It’s hard to know without access to the complete report.
On the other hand, the shape of the survival curve for the MyMD-1 mice is much flatter than the survival curve for the control or rapamycin mice in the ITP study. At 400 days after treatment only about 40% of rapamycin were alive in the ITP study, whereas something like 90% of the MyMD-1 mice are still alive here.
I’m cautiously excited because to my knowledge rapamycin has never been beaten head to head in any trial by a monotherapy. Also, MyMD-1 has moved into Phase II trials for sarcopenia after a successful Phase I so we may have human data relatively soon.
The control mice don’t start dying until about 400 days for male, and 600 days for females.
So yeah, looks odd to say the least.
And it seems they are playing sly with the whole FDA “aging/longevity” blockade, hoping that any approval of inflammation suppression in a sarcopenia/high inflammation cohort is going to be used by marketing as an “FDA anti-aging drug” approval.
“In a Phase 1 clinical trial of MYMD-1, we demonstrated the drug’s statistically significant efficacy in reducing levels of TNF-α, a key player in causing pathological aging, in the blood. The FDA has approved TNF-α reduction as the primary endpoint for our Phase 2 study, which we believe positions us well for a successful Phase 2 outcome,” said Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD. “The initiation of patient enrollment in this study advances our mission to slow the aging process, prevent loss of muscle tissue in aging, limit frailty, and extend healthy lifespan. MyMD has stated that there are no FDA-approved drugs for treating aging disorders and extending healthy lifespan humans"
Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty
The primary and secondary endpoints are inflammation markers and adverse events.
Aged 65 years or older, at the time of signing the ICFType of Participant and Disease Characteristics
This outfit/drug is targeting TNF-α blockers, going after the huge auto-immune/inflammation disease segment. The corporate presentation specifically makes reference:
"TNF-α blockers are the most prescribed drugs by revenue, globally $40 billion per year (e.g. Humira, Enbrel and Remicade). MyMD is targeting a market dominated by what is currently the best-selling drug in the world – AbbVie’s rheumatoid arthritis treatment [Humira]. “Targets adaptive (learned) immunity, not innate (first line of defense)”
One of the main benefits is oral vs injection.
So the real goal is to create a top selling TNF-α drug, but seems recently an added shift towards anti-aging hype…in case the TNF-α dosen’t turn out so well?
They claim in their yet unpublished mouse study: “They saw absolutely no loss of muscle strength in male mice compared to those on the other compounds. Females had some loss, but nothing like they did in the other groups”
A mouse study without a placebo control?
If this is absolute muscle strength, not normalized strength for weight loss (as in CR), would be unheard of, and somewhat incredulous. I have never read of any exogenous intervention slowing down/preventing muscle loss with age. A nicotine related plant alkaloid?
Also, their Phase 2/, 28 day clinical trails SPECIFICALLY only includes person WITH diagnosed sarcopenia AND high inflammation markers (pretty sick, frail). So ANY reduction in trajectory for this cohort would lay claim to “anti-aging”.
Look forward to the published results (hopefully legit) and pathway(s) insight.
Your thoughts are appreciated! With reference to the mouse trial, I agree. I thought it was strange that there was no placebo control reported. I suppose it was a cost cutting measure.
I’m not too concerned about their messaging on TNF alpha. It’s an enormously profitable sector and any biotech would want to develop a first in kind drug for those indications if they had the means. In his video interviews, Adam Kaplin, their CSO, strikes me as a true believer in the longevity space—at least he has the longevity talking points down. However, YMMV.
Cost cutting do not do a control arm of placebo mice in a mice longevity study? Isn’t this SOP, I think the research community will vilify them?
Re your Follistatin gene therapy paper, wow, amazing, never heard of this intervention. Fundamental cellular signalling/gene expression/telomore extension.
Significant lifespan extension in wild type mice, not some mutant transgenic.
Some notable takeaways:
“Visual histological analyses (not shown) revealed no malignancy or gross pathologies of the brain, liver, kidney, heart, muscle, bone, and lungs, in concordance with previous studies”
“Bodyweight peaked at 23-months for all treatment groups except for MCMVFST mice,
whose weights continued to increase until 27-months and were ~33% heavier than the age matched mock and WT controls. MCMVTERT treatment also showed less weight loss over time
compared to the mock and WT groups”
“Although MCMVFST treated mice were bulkier and could not outperform the control mice in climbing attempts, they paced faster on the bottom of the beaker”
“FST treated mice showed an increase in body mass, as expected based on previous
publications (45). We confirmed visually that skeletal muscle mass was indeed larger than that of
controls at necropsy (data not shown)”
This is definitely anti-aging in most all metrics, lifespan extension.
Any insight into if this is ever going to clinical trials, FDA approval?
Liz Parrish, another author on the paper, is affiliated with a company that claims to offer FST, telomerase and other gene therapies in Mexico. Over the past several years, Parrish generally hasn’t seemed to have a lot of interest in pursuing clinical trials for gene therapies, so I’m not confident that this therapy is even planned to head for clinical trials.
MyMD is a highly suspect company, they jumped on the cannabis band wagon a couple of years ago when that was the norm for getting higher share prices, before that they used to be Aker Bio, also listed on Nasdaq. Share holders has always been loosing money on this outfit since 1988.
The interviews on anti aging science they are doing are promotional interviews. Meaning they pay to be interviewed. Buyer be aware, just my 2 cents.