ASX Health Stocks: US FDA happy to review anal fissure drug; gives green light to Clarity's Phase 3 trial

Positive US FDA news for Acrux and Clarity Pharma
PharmAust’s monepantel shows positive results in Phase 1/2 Motor Neurone Disease (MND/ALS) trial
Paradigm Biopharma has completed recruitment of its Stage 1 Phase 3 clinical trial

US FDA accepts Acrux’s ANDA application

Acrux (ASX:ACR) rose this morning after announcing the US FDA accepted its application for a generic version (Abbreviated New Drug Application or ANDA) of Nitroglycerin Ointment, 0.4% for review.

Nitroglycerin Ointment, 0.4% is used to treat moderate to severe pain associated with chronic anal fissure, a condition that makes it difficult to pass hard or large stools.

While the FDA administers the review process, Acrux acknowledged the time to ultimate approval is influenced by the number and nature of questions that may arise as the FDA progresses its review.

Once the FDA grants approval, Acrux can finalise preparations with its already contracted commercial partner to commence marketing and sales of the product in the US.

Acrux says the total addressable market for the product is close to US$20m, and there are no approved or marketed ANDA products at present.

Clarity Pharma to commence Phase 3 after FDA meeting

Meanwhile, clinical stage radiopharmaceutical company Clarity Pharma (ASX: CU6) announced it will be commencing a pivotal Phase III trial of its 64Cu SAR-bisPSMA diagnostic in prostate cancer (PC) following a successful meeting with the US FDA.

Clarity says the FDA is supportive of its Phase III diagnostic clinical trial of 64Cu SAR-bisPSMA PET in 383 participants with untreated, histopathology-confirmed PC, who are proceeding to radical prostatectomy with pelvic lymph node dissection.

The aim of the Phase III trial is to assess the diagnostic performance of 64Cu SAR-bisPSMA PET to detect PC within the pelvic lymph nodes.

Evaluation will be across two imaging timepoints, Day 1 (day of administration) and Day 2 (approximately 24 hours post administration).

The trial is now expected to commence in late 2023.

Paradigm Bio completes Phase 3 recruitment

Paradigm Biopharma(ASX:PAR) has completed recruitment of its Stage 1 (dose selection) of the PARA_OA_002 Phase 3 clinical trial.

The participants are currently completing the protocol-mandated screening and randomisation which is expected to be completed early in Q3 of this year.

Paradigm has activated 120 clinical trial sites across seven countries, and is initiating a number of innovative recruitment initiatives.

Paradigm says the timeline for its New Drug Application (NDA) with the US FDA remains on track.

PharmAust’ monepantel shows positive results in MND trial

PharmAust (ASX:PAA) says preliminary data on its Phase 1/2 trial of its lead drug candidate monepantel (MPL) in Motor Neurone Disease (MND/ALS) indicate suppression of inflammation that may be responsible for disease progression.

MND/ALS is believed to develop and progress due to neuronal inflammation, and cell death due to production of misfolded proteins in brain tissue.

“Here we show that in Cohort 1 of oral monepantel in treating MND there is significant suppression of inflammatory markers,” said PharmAust’s executive chairman, Dr Roger Aston.

“In preclinical studies we have shown that monepantel crosses the blood-brain barrier. These results bode well as we analyse markers that predict MND disease progression.”

Volpara reduces credit facility, wins Microsoft award

Global leader in breast cancer detection software, Volpara Health Technologies (ASX:VHT), announced changes to its revolving credit facility.

In May of last year, Volpara obtained a NZ$10M revolving credit facility as part of its cash management planning.

However, since the revised strategy’s implementation in late July 2022, the business has operated on an approximately free cash flow break-even basis, with Q1FY24 delivering another strong quarter of cash inflows.

With over NZ$12M of cash on hand at the end of Q1FY24 and repeatable operating cash flow positivity in sight, the business has decided to reduce the revolving credit facility in place as it is no longer considered necessary.

Volpara also announced that it has won the global Healthcare & Life Sciences Partner of the Year Award, chosen from a set of more than 4,200 submitted nominations worldwide.

This award recognises a company that excels at providing innovative healthcare and life sciences solutions based on Microsoft cloud technologies.