Artelo Biosciences, Inc. (NASDAQ:ARTL) on Wednesday released interim results from its Phase 2 Cancer Appetite Recovery Study (CAReS) trial with ART27.13, the company’s peripherally acting cannabinoid receptor agonist for cancer anorexia-cachexia syndrome (CACS).
Affecting up to 80% of people living with cancer, CACS is marked by loss of appetite, weight loss and breakdown of muscle and fat.
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In the interim analysis, 18 evaluable patients -- primarily with lung and gastrointestinal cancers not receiving cyclic chemotherapy -- were included.
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Data Highlights
Patients escalated to the 1300 microgram dose achieved a +6.38% mean weight gain after 12 weeks, compared to a -5.42% average loss on placebo. The maximum gain observed was +18.5% on ART27.13 versus only +0.4% on placebo.
The maximum weight loss in the placebo arm was -17.4%, compared to just -3% in the ART27.13 group.
At one month, patients treated with ART27.13 experienced a +4.23% increase in lean body mass, while placebo patients lost -3.15%.
Patients receiving treatment showed improvements in activity scores and in moderate and vigorous activity, the latter being an endpoint that may be required by regulators for drug approval.
ART27.13 was well tolerated. The most common adverse events were mild or moderate. No new safety signals were observed, and interim safety results were consistent with Phase 1 of CAReS.
In a separate press release on Wednesday, Artelo Biosciences affirmed the strong interest expressed by multiple pharmaceutical companies awaiting ART27.13 CACS data.
The company said, “It is well-positioned to secure a development partner for ART27.13.”
“As a result of ongoing discussions with potential partners and the supportive clinical profile of ART27.13 for CACS, Artelo does not envision the need to internally fund a Phase 3 trial and believes a licensing transaction represents the most value-accretive path forward for shareholders,” the company added.
ARTL Price Action: Artelo Biosciences stock is down 9.10% at $8.23 at publication on Wednesday.
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