- Patrys plunges 20pc after announcing a delay in Phase 1 trial
- Nova Eye surged 20pc after getting the green light from the FDA
- Allegra Orthopaedics submits its spinal cage device for FDA approval
Therapeutic antibody development specialist Patrys (ASX:PXB) crashed 21% this morning after saying that it now only expects to commence the Phase 1 clinical trial of PAT-DX1 in the calendar year 2024, as opposed to second half of 2023.
The decision came after recent updates from its Contract Development Manufacturing Organisation (CDMO) regarding the timing of availability of clinical-grade PAT-DX1.
Despite prior successful manufacting test runs, Patrys’ CDMO has reported a sporadic issue relating to the cell line used to produce Good Manufacturing Practice (GMP) PAT-DX1.
While this issue is actively being investigated and resolved, it will result in a delay in the availability of investigational drug material to be used for Patrys’ Phase 1 clinical trial of PAT-DX1.
“We are disappointed that the delay in availability of clinical grade material is going to push our Phase 1 clinical trial of PAT-DX1 into calendar year 2024,” said Patrys’ CEO, Dr James Campbell.
“Once the sporadic issue affecting GMP production is resolved, we are confident the manufacturing and purification process developed and tested for PAT-DX1 can provide the material required to initiate the first human clinical trial of a deoxymab antibody.”
In the meantime, the final, non-clinical GLP toxicology studies of PAT-DX1 remain on-track with initial results expected in May.
“Furthermore, work on our full-sized IgG deoxymab, PAT-DX3, is progressing well and we expect to provide an update on this program in coming weeks,” said Campbell.
Nova Eye gets all clear from FDA
Nova Eye Medical (ASX:EYE) meanwhile surged by 20pc after confirming the US FDA has cleared the company’s newest generation canaloplasty device for canal-based glaucoma surgery, the iTrack Advance, for sale to surgeons in the US to treat glaucoma.
The original iTrack was the pioneering canaloplasty device that first established canal surgery for glaucoma. To date, approximately 120,000 surgeries have been performed by surgeons worldwide with outstanding clinical efficacy and safety profile.
The iTrack microcatheter is the only product that is indicated for canal surgery to treat glaucoma with viscodilation alone.
With FDA 510(k) clearance secured, Nova Eye can immediately commence the marketing and sales of iTrack Advance to US ophthalmologists for the treatment of glaucoma.
A full product launch is planned for the American Society of Cataract and Refractive Surgery (ASCRS) annual conference scheduled for May 5-8 in San Diego.
“Having pioneered canaloplasty technology with the original iTrack device, Nova Eye is now well positioned to materially penetrate the expanding canal surgery market with iTrack Advance,” said Nova Eye CEO, Tom Spurling.
Other ASX Healthcare news today
Meanwhile, Allegra Orthopaedics (ASX:AMT) announced the submission of its 510(k) for the Sr–HT–Gahnite Spinal Cage Device to the FDA.
The submission follows the completion of a range of studies where successful outcomes were achieved, including demonstrating the product’s mechanical strength, physical properties, safety, and efficacy in cervical fusion.
Additionally, thorough sterilisation and biocompatibility evaluations have been performed providing further evidence of the device’s biological safety and readiness for clinical settings.
Allegra Orthopaedics is the sole proprietor of the Sr-HT-Gahnite material and aims to apply the technology to fulfilling unmet needs including spine, hip & knee, and extremities.
Osteopore (ASX:OSX) has officially acquired multiple medical distribution businesses, which will represent around 40%-45% of its global sales.
Through the acquisition, the company is anticipating a boost in revenue primarily from its aesthetic rhinoplasty product line.
OSX believes the acquisition is a strategic step towards increasing the aesthetic (rhinoplasty) revenue segment, and accelerating the path towards profitability.
By gaining a vertically integrated business model, Osteopore can control direct retail sales in key markets such as South Korea, and eliminates the distribution layer between the company and its end customers.