Several ASX companies are repurposing or resurrecting abandoned or under utilised drugs
Paradigm Biopharmaceuticals identified the potential of FDA-approved PPS that has a long track record of treating inflammation
Starpharma has developed technology to improve the effectiveness and safety of pharmaceutical drugs, especially cancer treatments
The statistics are grim when it comes to pharmaceutical drugs which make it to market even after demonstrating success in late stage trials.
Seasoned biotech executive and Race Oncology (ASX:RAC) CEO Dr Daniel Tillett says up to 25% of potential pharmaceutical treatments never reach the market with various reasons impeding progress of what are often promising drugs.
He says companies often shift their focus during the extensive drug development process, resulting in abandonment due to factors like short patent life or divergence from commercial objectives.
The adverse impact of mergers and acquisitions in the pharmaceutical sector can also spell doom for effective treatments if the acquiring company lacks interest.
Furthermore, Tillett says complex administration requirements can undermine the commercial viability of otherwise efficacious drugs when compared to simpler alternatives.
But there are strategies rejuvenate abandoned drugs, including out-licensing to new firms for clinical redevelopment or reformulation to improve delivery methods.
Repurposing for rare diseases, supported by orphan drug designation providing market exclusivity, presents another avenue for resurrection.
In part 3 of our series we look at more ASX-listed biotech companies resurrecting or repurposing abandoned or under utilised drugs.
Paradigm Biopharmaceuticals (ASX:PAR)
PAR identified the potential of PPS, an FDA-approved drug that has a long track record of treating inflammation.
PAR managing director Paul Rennie told Stockhead PPS was developed in Germany in 1949 and has established anti-inflammatory and anti-thrombotic properties.
“It has been in use for over 60 years and as such its safety profile has been firmly established,” he says.
“By working closely with the proprietary manufacturer of PPS, we have been able to build upon the substantial knowledge and expertise available from earlier regulatory filings.”
He says this includes decades of accumulated toxicology safety data, manufacturing ‘know-how’, and extensive published information about PPS’s mechanisms of action, which primarily involve interactions with proteins impacting inflammation.
PAR has been able to progress this knowledge to conduct two Phase 2 clinical trials treating patients with osteoarthris and have recently completed the first stage of its Phase 3 program by using PPS by subcutaneous injection (iPPS).
“Through these clinical trials PAR has recruited more than 750 participants into the study, and has also been able to provide prescribing doctors with iPPS to treat over 700 patients under the TGA special access scheme providing significant real world evidence of the benefit iPPS can provide to those suffering with osteoarthritis.”
Rennie says the company believes in identifying and transforming underutilised molecules is the most optimal path to addressing an unmet need like osteoarthritis.
“Our approach is to take an existing approved drug, which has demonstrated safety in its approved indication/s and repurposing that drug in a new patented therapeutic application,” he says.
“Over 30% of new drugs or biologics approved or launched globally represent drugs repurposed for new indications, reformulations or new combinations of existing drugs.”
Rennie says there are several potential benefits of using a drug repurposing/repositioning strategy in comparison to conventional drug development programs.
“The reduction in the time, cost and risk associated with the clinical and commercial development pathway to taking new products to market is significant, and offers new avenues of hope for patients,” he says.
“The cost and complexity of starting with a new molecule is high, encourages iterative progress and reduces the potential for genuine discovery.”
Starpharma (ASX:SPL)
SPL has developed its proprietary Dendrimer Enhanced Products platform (DEP) to improve the effectiveness and safety of drugs, especially cancer treatments.
DEP is based on dendrimers, which are highly branched polymers, to enhance the delivery of cancer treatments and in turn reduce toxic side effects such as neutropenia, nausea, severe diarrhoea and hair loss from chemotherapy agents.
CEO and managing director Cheryl Maley says SPL’s scientists can modify the properties of a wide range of drugs using its DEP dendrimer technology to achieve the desired function.
“For example, we can increase a drug’s half-life, which can result in several patient benefits, including a prolonged therapeutic effect, reduced frequency of administration, steadier blood levels, and potential for increased efficacy,” she says.
“In cancer applications, DEP dendrimers also provide the ability to directly target therapeutic payloads to tumours to increase efficacy.”
Maley says SPL has achieved significant progress in developing three clinical-stage candidates, which are intended as improved reformulated versions of established chemotherapy drugs that have been used in patients for many years.
“The dendrimer-based versions of these drugs have demonstrated enhanced tolerability, with a better side effect profile, and similar or improved efficacy outcomes for patients in Phase 2 trials,” she says.
“Starpharma is also collaborating with other companies to enhance the performance of drugs in their development pipeline, using Starpharma’s dendrimer technology.”
She says DEP dendrimers can be applied to a wide range of drug/therapeutic payloads, including chemotherapies and radioisotopes.
SPL recently announced it had entered into a strategic partnership with Medicxi, a leading life sciences investment firm dedicated to financing companies developing innovative medicines, to co-found a new UK-based company called Petalion Therapeutics.
Petalion will initially focus on developing a novel targeted dendrimer-drug conjugate therapy in oncology, using SPL’s proprietary DEP dendrimer platform technology.
Medicxi will fund Petalion with an initial investment of up to ~$38 million to finance the development of a novel oncology drug candidate.
SPL will license certain intellectual property to Petalion as required for the research, development, manufacture and commercialisation of the potential new therapeutic and, in exchange, will receive an equity holding of 22.5% in Petalion.
The PAR & SPL share price
At Stockhead, we tell it like it is. While Paradigm Biopharmaceuticals is a Stockhead advertiser, the company did not sponsor this article.
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