An antibody-drug conjugate, made with a toxic mushroom rather than chemotherapy, has shown promising results in a Phase 1/2a trial in patients with multiple myeloma. The drug, HDP-101 (pamlectabart tismanitin), is being developed by Heidelberg Pharma AG of Germany. In October it received a ‘fast track’ designation from the US Food and Drug Administration for its potential as a treatment for severely ill and heavily pretreated patients.
A trial for adults with major depressive disorder failed to significantly reduce the severity of the disorder compared with a placebo, according to the sponsor Neurocrine Biosciences Inc of San Diego, US. The Phase 2 study enrolled 73 adults with a diagnosis of major depressive disorder and an inadequate response to at least one antidepressant in their regular treatment paradigm. The product, NBI-1070770, is a negative allosteric modulator of a subunit of a receptor that plays a role in the working memory. Participants received the drug or a placebo for four weeks.
Germany-based biotech InflaRx NV, has published positive Phase 2a data for a new small molecule drug for the treatment of two skin diseases: hidradenitis suppurativa and chronic spontaneous urticaria. The drug, INF904, is an inhibitor of the C5a receptor which modulates the body’s inflammatory responses. In a basket study of patients with the two diseases, the drug achieved rapid disease control. In the case of hidradenitis suppurativa this involved decreases in measures of nervous system changes.
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Natural history studies underpin clinical research
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Public Policy
EU pharma reform meets US MFN pricing
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