Trial of Long Covid treatment - AXA1125 from Axcella Therapeutics, 2021

rvallee

rvallee

Senior Member (Voting Rights)
Oxford to test potential treatment for fatigue in long COVID patients
https://www.ox.ac.uk/news/2021-10-29-oxford-test-potential-treatment-fatigue-long-covid-patients

Dr Alison Schecter, President of R&D at Axcella, said: 'While Long COVID’s enormous patient and socioeconomic burden has become apparent, its underlying pathophysiology is now emerging,” said . “In two prior successful clinical studies and in preclinical models, AXA1125 has demonstrated an ability to reverse mitochondrial dysfunction and improve energetic efficiency via increased fatty acid oxidation, restored cellular homeostasis, and reduced inflammation. This provides us with confidence about its potential to help the growing number of patients who are suffering from COVID’s debilitating effects long after contracting the virus.”

The Phase 2a trial will be a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with exertional fatigue related to Long COVID. Approximately 40 patients will be enrolled and randomized evenly to receive either AXA1125 or a matched placebo.​

Unimpressed by the insistence to reduce everything to fatigue but whatever...
 
https://www.clinicaltrialsarena.com/news/axcella-trial-long-covid-treatment/

Axcella Therapeutics has commenced a Phase IIa clinical trial to assess its therapy, AXA1125, to potentially treat Long Covid patients.

A complex condition, Long Covid is also called post-Covid-19 and post-acute sequelae of Covid-19 (PASC).
On 22 October, the UK Medicines and Healthcare products Regulatory Agency (MHRA) had accepted the company’s clinical trial authorisation (CTA) submission for Phase IIa.

Anticipated to commence at the Oxford Centre for Clinical Magnetic Resonance Research by this year-end, the randomised, placebo-controlled double-blind trial will assess the efficacy and safety of AXA1125 in subjects with exertional fatigue linked to Long Covid. It will enrol nearly 40 subjects, who will be categorised to receive either 67.8g AXA1125 daily or a matching placebo for 28 days. The trial will be led by the University of Oxford’s Radcliffe Department of Medicine scientists and have a safety follow-up duration of one week.

Axcella anticipates top-line results from the trial during the middle of next year.

The improvement of mitochondrial function in the skeletal muscle from baseline to day 28 as assessed by variations in phosphocreatine (PCr) recovery time will be the trial’s primary goal.
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When I've taken amino acids such as BCAA it's in powder form mixed into a shake, drink, as with capsules I'd be taking than all day.

10 to 15g of powder in 200ml of liquid is not unusual, more if it's a whey based shake mix with something else added, where the whey component is 30g per 200ml of liquid, and then another 15g on top in the same 200ml of liquid.

One drink, 45g of powder, vs 45 capsules, for the same dose amount.
 
Amino acids are the constituents of protein.

According to the Dietary Reference Intake report for macronutrients, a sedentary adult should consume 0.8 grams of protein per kilogram of body weight, or 0.36 grams per pound. That means that the average sedentary man should eat about 56 grams of protein per day, and the average woman should eat about 46 grams.
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Edit: It appears from a later post on this thread that there's a misplaced decimal point. The dose is more like 6g, not 60g.

So if people are being dosed with 67.8g amino acids daily, that's more than doubling their protein intake. I assume it's a particular secret mix of aa's, possibly as others are suggesting bcaa's which I am aware some people with ME take on the basis that they are supposed to help energy production, if I remember correctly as an alternative energy source to glucose (carbs) to feed into the citric acid cycle in the mitochondria.

Do correct me if this does't make sense.
___________________

Axcella said:
The improvement of mitochondrial function in the skeletal muscle from baseline to day 28 as assessed by variations in phosphocreatine (PCr) recovery time will be the trial’s primary goal.
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There seems to be some doubt about this as a measure.

1999
Skeletal muscle phosphocreatine recovery in exercise-trained humans is dependent on O2 availability
L J Haseler 1, M C Hogan, R S Richardson
Affiliations
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Letters to the Editor (Nature, 2012)

Can we simply infer mitochondrial function from PCr resynthesis after exercise in skeletal muscle?
says this:
Overall, it is of utmost importance to keep in mind that one cannot simply infer mitochondrial function on the basis of measurements of the rate constant of PCr resynthesis given that end-of-exercise conditions have been shown to exert a strong influence
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Trish said:
bcaa's which I am aware some people with ME take on the basis that they are supposed to help energy production, if I remember correctly as an alternative energy source to glucose (carbs) to feed into the citric acid cycle in the mitochondria.
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I take them because they reduce PEM and help me digest carbs, but I've no idea why.

I once spent six or seven weeks getting though a tub of identical-looking but different supplements, which I'd picked up thinking they were BCAAs. I cursed the brand for selling fakes because they didn't work at all, but I couldn't afford a replacement tub. I only actually noticed when I washed out the jar for recycling that they were creatine or something.

:rolleyes:
 
The study products were packaged in dry powder stick packs. Each AXA1125 stick pack was composed of leucine 1.00 g, isoleucine 0.50 g, valine 0.50 g, arginine HCl 1.81 g, glutamine 2.00 g, and NAC 0.15 g (5.65-g free AA/stick pack), and each AXA1957 stick pack was composed of leucine 1.00 g, isoleucine 0.50 g, arginine HCl 1.61 g, glutamine 0.67 g, serine 2.50 g, carnitine 0.33 g, and NAC 0.43 g (6.76-g free AA/stick pack). Each dose (2–4 stick packs) was to be reconstituted as an orange-flavored suspension in 8 oz (∼240 mL) of water and administered 30 minutes before a meal. The initial dose was administered at the day 1 (baseline) visit.
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From:
Safety, Tolerability, and Biologic Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty Liver Disease
https://journals.lww.com/ajg/Fulltext/9900/Safety,_Tolerability,_and_Biologic_Activity_of.62.aspx
 
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