• PYC Therapeutics will progress a second drug into human trial
  • Memphasys makes first commercial sales in  Japan
  • FDA says Botanix’s Sofpironium Bromide has no significant issues


PYC sees a second drug in program in clinical trials

RNA therapies specialist PYC Therapeutic (ASX:PYC) jumped 9% this morning after announcing that following successful non-clinical data, it will now progress a second drug development program to human trials.

The second asset in PYC’s drug development pipeline, PYC-001, which is an investigational drug candidate for the treatment of ADOA (Autosomal Dominant Optic Atrophy), is now expected to enter human trials in 2024.

The decision to enter a human trial follows the completion of formal toxicological studies, which showed PYC’s RNA therapeutic for ADOA reached the targets cells affected by the disease in an animal model.

Up to today, insufficient delivery of drug to the target cell remains the primary challenge for precision therapies.

Pre-clinical in-patient-derived models also established that PYC’s RNA therapeutic can modulate expression of the underlying gene responsible for causing the ADOA disease.

ADOA is a progressive and blinding eye disease of childhood which has an estimated ~$2 billion market given there are no treatment options available for patients today.

“We are very much looking forward to seeing what addressing the underlying cause of ADOA can do for patients in the context of this stellar non-clinical data,” says PYC CEO, Dr. Rohan Hockings.

PYC’s first and lead program is VP-001 – an investigational drug candidate for the treatment of Retinitis Pigmentosa type 11 (RP11). The first RP11 patients to receive VP-001 are expected to be dosed next month.


Memphasys makes first sale in Japan

Reproductive specialist Memphasys (ASX:MEM) raced away higher by 12% after announcing the first commercial sale of 30 sterile single-use Felix cartridges and console to the prestigious Kobe ART clinic in Japan.

The Felix System is a patented, automated single-use cartridge that gently separates high-quality sperm from a semen sample in six minutes for use in human IVF procedures.

The clinic made the order based on the strong endorsement of Felix in two recently published papers by leading global IVF clinics.

Memphasys says that Japan represents one of the top five addressable markets globally for the Felix System with the potential market opportunity exceeding $100 million. No figures were disclosed in today’s deal.

The company also announced that its Indian partner, Coimbatore Women’s Hospital Centre, has reported the first live birth of a healthy baby boy using the Felix System.

The Coimbatore Hospital is a KOL (Key Opinion Leader) partner of Memphasys. KOL is a recognised as the esteemed practitioners of the global IVF sector and a key reference point for the wider IVF community on industry innovation and leadership.

India also represents one of the top five addressable markets globally for the Felix System with the potential market opportunity exceeding $50 million.

As an early mover in the market, MEM has already acted by submitting a voluntary product registration with CDSCO as an initial strategy to sell non-commercial quantities in India.


The FDA sees no issues with Botanix submission

Botanix Pharmaceuticals (ASX:BOT) says the US FDA has conducted the mid-cycle review meeting for Botanix’s lead product, Sofpironium Bromide.

The mid-cycle communication indicated that no significant issues have been identified by FDA as a result of its review.

Likewise, there were no major clinical safety issues, no risk management issues, or advisory board requirements identified by FDA.

As the review process for approval continues, the FDA has indicated that continued discussions will focus on labeling, clinical outcome assessments, patient instructions and brand name.

Botanix says the planned approval date for Sofpironium Bromide in September 2023 remains on track.


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