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

Jaybee00 said:
No, I think the 60g figure is likely correct—each stick pack was 6g so they probably had 10 packs per day. (One dose is 2-4 sticks and probably repeated throughout the day).

“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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The slides that you linked to, @Jaybee00, indicate that AXA1125 was taken twice a day (33.9g per dose).

There is a discrepancy between the press release(s) and the slides: the latter state that the treatment group achieved a mean reduction of 5.45 points on the Chalder fatigue scale compared to the placebo group at the 4 week outcome, while the former state that this reduction was only 4.3 points, but the p-values match (p = 0.0039):
The mean change in total fatigue score versus placebo was -4.30, good for a p-value of 0.0039. The figures for physical and mental scores were -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively.

https://endpts.com/exclusive-in-phi...-primary-goal-but-did-so-on-fatigue-measures/
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yXLG3Ct.jpg


(Grey: placebo, orange: treatment)
 
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Axcella surges 48% after hours as co submits drug application for long COVID treatment
    • Axcella Therapeutics (NASDAQ:AXLA) on Monday said it had submitted an investigational new drug application to the U.S. Food and Drug Administration for a mid-to-late stage trial of its long COVID fatigue treatment AXA1125.
    • Shares of the micro-cap clinical-stage biotech jumped 48% to $0.64 after hours.
    • The company also reported some progress with UK's drug regulator.
    • AXLA said "it had received regulatory guidance from (the UK's) Medicines and Healthcare products Regulatory Agency ... supporting a single trial that could serve as the registration trial for patients with Long COVID fatigue."
    • The guidance aligns on key measurements for a registration trial, including main goal and trial design elements, AXLA added.
 
Also at that seeking alpha site:
Axcella CFO to depart among 85% staff cut in program reprioritization, restructuring
Dec 15 2022
  • Axcella Therapeutics (NASDAQ:AXLA) said it is exploring strategic alternatives and reducing its workforce by 85% amid a reprioritization of its programs due to capital constraints.
  • Among the departing employees are CFO Bob Crane and Chief People Officer Virginia Dean.
  • Axcella said it will focus on its program for Long COVID as AXA1125 had shown promise in a phase 2a trial. The company is engaging with regulators in the U.S. and Europe to advance its Long COVID Fatigue program into a potential registration trial.
  • In addition, Axcella said it will be discontinuing its ongoing phase 2b trial of AXA1125 in Nonalcoholic Steatohepatitis (NASH) (a type of liver disease), while keeping the option to revisit the program if resource availability changes.
  • The company added that it has reached an agreement with SLR Investment to paydown the debt obligations of a previous agreement.
  • Axcella noted that it is exploring a range of strategic alternatives and is working with an investment bank to act as a strategic advisor for this process.
  • The company, however, added that no assurances can be made if a strategic transaction will come to fruition.
Sounds as though it is the last roll of the dice, perhaps they are trying to sell all/some of the company with the assistance of an investment bank.
 
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