- Axcella Health Inc has reported topline results from the Phase 2a study to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.
- In the study, 41 subjects were enrolled and randomized to receive either 67.8 grams per day of AXA1125 or a matched placebo.
- Subjects who received AXA1125 had improvements in mental and physical fatigue measures that were both highly statistically significant and clinically relevant compared to those who received placebo.
- Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30, -2.94, and -1.32, respectively.
- Clinically meaningful shifts in physical and mental fatigue severity were also noted in subjects who received AXA1125 than the placebo.
- There was a notable trend toward significant improvement in serum lactate levels after a 6MWT in AXA1125 subjects (p=0.0730). AXA1125 was safe and well tolerated, with no significant adverse events reported by study subjects.
- Eliem Therapeutics Inc has reported results from its Phase 2a trial investigating ETX-810 for lumbosacral radicular pain (LSRP).
- In the study, ETX-810 did not achieve statistically significant separation from placebo on the trial's primary endpoint, which assessed the change from baseline to week 4 in the weekly average of the daily pain score.
- This result is consistent with the lack of separation from placebo observed in the Phase 2a clinical trial in diabetic peripheral neuropathic pain, as reported in April.
- Therefore, the company has elected to discontinue further development of ETX-810.
- The company recently updated that its capital is sufficient to fund key pipeline catalysts and operations until mid-2024.
- With the discontinuation of ETX-810, the company anticipates that its cash runway will extend beyond that time.
- Incyte Corporation's Q2 adjusted EPS reached $1.01, compared to $0.8067 posted a year ago. Analysts had estimated $0.75.
- Sales increased 29% Y/Y to $911.39 million, beating the consensus of $815.17 million.
- The company reported an operating income of $254.43 million, compared to $140.84 million posted a year ago.
- Jakafi net product revenues increased 13% Y/Y to $597.67 million, primarily driven by volume growth.
- The company said that the launch of Opzelura in atopic dermatitis continues to progress well, and in recent weeks, improvements in reimbursement have translated into an increase in covered claims.
- Q2 revenues were temporarily impacted by the shift from free drug to paid prescription. Patient demand and satisfaction remain strong," said Hervé Hoppenot, Chief Executive Officer, Incyte.
- The Olumiant royalty revenues fell 16% to $30.25 million.
- Guidance: Incyte expects FY22 Jakafi net product revenues at $2.36 - $2.40 billion (versus prior guidance of $2.33 - $2.40 billion) and other Hematology/Oncology net product revenues unchanged at $210 million - $240 million.
