US FDA Approves Clarity Pharma’s IND Application, Nyrada Announces Target for Its Brain Injury Program

US FDA Approves Clarity Pharma’s IND

Radiopharma-focused biotech, Clarity Pharmaceuticals (ASX: CU6) gets the go-ahead from the US FDA as the pharmaceutical company’s Investigational New Drug (IND) application was approved. This approval from the US FDA was received for Clarity’s SAE-Bombesin product, an imaging agent that will enable the progression into its phase 2 “SABRE” imaging trial on prostate cancer. The phase 2 SABRE study will enroll about 50 PSMA-negative prostate cancer patients in the US.

The main objective of the SABRE trial is to investigate the safety and tolerability of 64Cu SAR-Bombesin, and its ability to detect the recurrence of prostate cancer correctly. This is because approximately 20% of prostate cancer patients battling biochemical recurrence are PSMA-PET (Prostate-Specific Membrane Antigen) negative. This means they are unsuitable for the currently approved agents in the market. The trial to use SAR-Bombesin for prostate cancer is built upon the promising clinical data from the pilot trial, led by Prof Louise Emmett of St Vincent’s Hospital, Sydney on using 64Cu SAR-Bombesin in breast cancer.

Dr Alan Taylor, the Executive Chairman of Clarity Pharmaceutical, said, “We look forward to further progressing the development of SAR-Bombesin and hope it will provide a new and effective diagnostic option for prostate cancer patients. Combined with the clinical, environmental and logistical benefits enabled by the copper isotope pairing, SAR-Bombesin has the potential to provide this large patient population with accurate and precise detection and treatment of prostate cancer.” Dr Taylor added, “We anticipate the SABRE trial to commence shortly and the theranostic trial to commence in 2023.”

Elsewhere in the biotech space, Nyrada Inc. (ASX: NYR) has unveiled its target for its brain injury program. In a recent announcement from the biotech company, a class of proteins known as the “Canonical” Transient Receptor Potential, or TRPC ion channels, will be targeted. According to animal studies and other published literature, the TRPC class of protein; TRPC3,6 and 7 are responsible for causing a larger injury following a traumatic injury or stroke, resulting in outcomes such as increased disability and reduced survival rate.

Nyrada has filed a provisional patent covering some of the molecules that block these protein channels, with the patent anticipated to cover Australia first, followed by the UK and the US.

Featured Image: Megapixl © Sofiaworld

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