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Health & Biotech
PYC Therapeutics (ASX:PYC) has provided an update on its ongoing clinical trials for VP-001, an investigational drug candidate designed to treat Retinitis Pigmentosa type 11 (RP11).
RP11 is a rare and severe eye disease that leads to blindness.
The company has previously highlighted encouraging developments in its trials, showcasing the drug’s potential to significantly improve visual function in affected patients.
In its latest update, PYC revealed that VP-001 has continued to show positive effects in patients from the Single Ascending Dose (SAD) study.
The drug was initially administered to a patient, and two months later, this individual showed notable improvements in visual function.
This improvement has been sustained, with further positive results observed four months after treatment.
A second patient in the same cohort has also demonstrated similar progress, with their visual function improving to levels deemed clinically significant by the US FDA.
PYC is also advancing with its Multiple Ascending Dose (MAD) study, where initial dosing in the first cohort was completed in July.
Patients in this study will continue to be monitored, with the next group of patients scheduled to receive their doses in the coming months.
The first patient in the SAD study’s extension phase has received a second dose, marking the start of a regimen involving multiple doses of VP-001.
“It is exciting to see VP-001’s ability to address the root cause of RP11 in ‘retina in a dish’ models now translating to improved visual function in RP11 patients,” said PYC’s CEO, Dr. Rohan Hockings.
The company’s near-term goal is to establish clinical proof of concept through these trials.
Successful outcomes could lead to the initiation of a registrational study aimed at securing regulatory approval and launching the drug in the market.
Looking ahead, PYC will continue to gather data from ongoing trials, including both single and multiple dose studies, with the aim of providing further evidence of the drug’s efficacy.
Meanwhile, LTR Pharma (ASX:LTR) has provided an update on its erectile dysfunction treatment, the fast-acting nasal spray Spontan.
The company has now successfully prescribed Spontan to its first patients under the Therapeutic Goods Administration’s (TGA) Special Access Scheme.
This development highlights Spontan’s potential in the urgent need for a fast-acting, on-demand treatment for erectile dysfunction (ED).
The initial prescriptions were managed by the Restorative Sexual Health Clinic (RSHC), led by Melissa Hadley Barrett, a prominent Nurse Practitioner and Sexologist.
RSHC is known for its evidence-based approach to sexual health, and Barrett’s involvement adds significant credibility to the treatment’s introduction.
Barrett, an influential figure in sexual health education, will play a crucial role in sharing insights about Spontan at international conferences and in scientific publications.
“We see Spontan as a valuable addition to our therapeutic capability. Spontan complements our holistic approach, offering our patients an innovative option to help address their sexual health concerns and enhance overall well-being,” Barrett said.
LTR Pharma’s strategic approach includes leveraging Key Opinion Leaders (KOLs) to facilitate Spontan’s market introduction.
This method ensures a well-planned rollout and helps gather valuable real-world data on the product’s effectiveness.
The engagement with KOLs will also support the product’s broader acceptance in the medical community and contribute to increased awareness and knowledge about Spontan.
LTR Pharma Chairman Lee Rodne said the early use of Spontan marks a pivotal moment for the company.
“The use of Spontan under the early access program marks a watershed moment for LTR Pharma,” Rodne said.
“It demonstrates both the urgent need for fast-acting ED medication and Spontan’s potential to address a high, unmet need for a fast and on-demand ED treatment and allows for hands-on, real-world experience with Spontan.”
At Stockhead we tell it like it is. While LTR Pharma is a Stockhead advertiser, it did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
