CytoDyn plans 3-arm phase 3 trial for leronlimab with/versus remdesivir in redacted

Leronlimab was administered to more than sixty patients with redacted under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyn’s Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate redacted population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.

“We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from redacted. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for redacted,” said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.

CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone,” said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

ICER postulates worth of Gilead’s donation of 1.5M doses of remdesivir

$9.32 per 10-day course or $4500 per course – ICER presents alternative pricing models for remdesivir as a treatment for redacted. […]
Gilead has already donated its current stock of ~1.5M doses to the US government, and plans to produce ~1M doses more by the year-end.

The Institute for Clinical and Economic Review (ICER) released on 5/1/2020, the results of its initial analyses to inform public debate of pricing for Gilead Sciences’ (remdesivir and other future treatments of redacted. ICER has developed ICER-redacted models comprising two alternative pricing paradigms for redacted treatments in collaboration with external academic partners: 

  • “cost recovery” for the manufacturer, representing an estimate based on peer-reviewed methods of calculating the minimum costs of production for a course of therapy; and
  • traditional “cost-effectiveness” analyses looking at the incremental health benefits and costs within the health system. 

In the base case cost recovery calculation, the costs of research and development were set to zero, as remdesivir was “previously developed as part of a suite of agents for potential use in chronic Hepatitis C.  Given that the manufacturer successfully launched other drugs for Hepatitis C, it seems reasonable that any sunk costs for research and development have already been recouped in the successful market experience of the manufacturer’s other treatments in that area.”

The traditional cost-effectiveness model is “based on the estimates of benefits seen in the Adaptive redacted Treatment Trial (ACTT). … The model captures quality of life improvements, mortality benefits, and the benefits of fewer days in the ICU, on ventilation, and in hospital.”

Gilead’s antiviral drug remdesivir has shown success in helping redacted patients recover faster.

Gilead donated its entire supply of the drug to the U.S. government. 

“Gilead expects to produce more than 140,000 rounds of its 10-day treatment regimen by the end of May and anticipates it can make 1 million rounds by the end of this year.” [from CNBC news release]

Remdesivir receives emergency use authorization

As expected, the FDA has approved the emergency use of Gilead Sciences’ (NASDAQ:) remdesivir for the treatment of redacted infection. […]
  • President Trump made the announcement at a White House event with company CEO Dan O’Day.
  • More details: Vice-President Pence says 1M vials of the drug will begin to be distributed to hospitals on Monday. CEO O’Day says some patients benefit from as few as five doses.
  • O’Day further says the company is now looking to improve treatment by combining remdesivir with other drugs.
  • From the FDA approval letter: “It is reasonable to believe that the known and potential benefits of [remdesivir] outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe redacted.”
  • Approval was a foregone conclusion after two studies showed that it shortened recovery time in severely ill patients, the first drug to demonstrate a clear treatment benefit.
  • Shares have pared earlier losses, now down 4.5%

– they did a good thing once – eradicated HCV in theory. They were punished for it – stock went from $130 to $80 – and I used to hold then, at $114. Now the market is spooked because they think is going to do another good samaritan act, donating remdesivir. Market doesn’t understand that it isn’t entirely a donation. However, nobody really knows remdesivir’s potential in this strange market. Nobody knows what will happen to Gilead’s cancer franchisee – such as it is. I have felt, for years now, that Gilead is floundering like a beached fish. I would buy this for its potential, but only if it reaches 52-week lows, or at least $70, like these analysts predict.