Neuphoria AFFIRM-1 trial misses primary endpoint, to discontinue SAD program

Neuphoria Therapeutics (NEUP) announced that the AFFIRM-1 Phase 3 trial of BNC210 for the acute treatment of social anxiety disorder did not meet its primary endpoint of change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale scores. In addition, analyses of secondary endpoints did not demonstrate statistically significant differences. The safety and tolerability profile of BNC210 continued to be favorable and was consistent with previously reported studies. Based on the results from the AFFIRM-1 trial, Neuphoria will discontinue further development of its SAD program. Given previous positive data with chronic daily dosing, Neuphoria also plans to evaluate next steps for further development of BNC210 in post-traumatic stress disorder. The company plans to conduct a full strategic review of its operations and portfolio and to provide an update by year-end. The company has an ongoing partnership with Merck (MRK). MK-1167, one of two positive allosteric modulator candidates being advanced in the strategic partnership with Merck, is currently being evaluated in a Merck-led Phase 2 trial in Alzheimer’s disease. Merck is responsible for all costs of this program, and through the partnership, Neuphoria is eligible to receive up to $450M in additional milestone payments for certain development and commercial milestones plus royalties on net sales of any licensed medicines. As of June 30, Neuphoria’s cash and cash equivalents were $14.2M. The company expects its current cash position to be sufficient to fund operations through the second fiscal quarter of 2027.