Biocurious: Sometimes an effective therapy lies not just with the drug, but how it is delivered

• The Nasdaq-listed Gelteq has mastered pouch delivery for people who find it difficult to swallow
• ASX IPO candidate Vaxxas is working on the needle-less delivery of vaccines
• ASX companies including LTR Pharma and Wellnex Life have devised alternative delivery products that subvert the paradigm

Given the arduous path to drug development, there’s nothing like the joy of bringing an important or even life-saving therapy to market.

But is the treatment being delivered in the best – and safest – manner?

Increasingly, investors and clinicians are paying attention to alternative drug-delivery systems that increase the bioavailability of the active ingredient.

One reason is that when drug patents are running out, pharma companies can increase the commercial life of a drug with alternative delivery.

In some cases, the treatment can’t be delivered in traditional tablet form at all, or the patient’s renal function is compromised which means they can’t take a pill.

Targeting the low-hanging fruit

According to the Melbourne based, Nasdaq-listed Gelteq, many people are afflicted with dysphagia, a weakness in the throat muscles leading to inability to swallow a pill.

Gelteq stems from CEO and co-founder Nathan Givoni’s work as a dietician, when he discovered that both seniors and young people were struggling to swallow.

In particular, an obstetrician identified problems with pregnant women having problems with the oral glucose ‘challenge’ test (to diagnose diabetes).

In cahoots with a small Victorian government grant via the Monash Medicines Innovation Centre, Givoni and business partner Simon Szewach developed pouch-based gels able to deliver high doses of sugars and vitamins.

Gelteq’s first port of call was pouch-erising sports nutraceuticals – a low-hanging fruit market given sportspeople are familiar with pouches for energy drinks and the like.

“We have a range of nutraceutical products such as mixed vitamins and collagen, which is all the rage in the anti-ageing sector.” Givoni says.

“We were in technology-build mode for about five or six years, but in the last three months we have pushed the button to get products out.”

This won’t hurt a bit

The unlisted Vaxxas is campaigning to end the jab – but it has nothing to do with Robert F Kennedy Junior’s anti-vax stance.

Rather, the Brisbane based company is developing a high-density microarray skin patch, or HD-MAP, to deliver vaccines through the skin.

Vaxxas was founded in 2011 by the university’s commercialisation arm, Uniquest.

The technology gained the attention of Boston’s Healthcare Ventures, in which the Queensland Investment Corporation was a partner.

Under an agreement inked in 2020, Merck of the US has exclusive rights to use the HD-MAP platform for an undisclosed Merck vaccine, with an option to use it for two others.

Naturally, during the pandemic the company’s attention turned to developing a needle-free Covid vaccine. This program is still on the Vaxxas slate, as is a needle-free avian influenza A (H7N9) vaccine.

The company is enrolling 258 healthy participants in a local, phase I trial.

This one’s kindly funded by America’s disaster preparation agency, the US Biomedical Advanced Research and Development Authority (BARDA).

Less drug, more bang

The trial is being carried out with or without the use of an adjuvant, which boosts the immune response of a participants who have never encountered the targeted virus before.

The company has carried out previous clinical studies for seasonal influenza with no adjuvant.

This resulted in “comparable immune responses” using only one-sixth of a traditional needle dosage.

“These promising results give us hope that the unadjuvanted formulation we’re using in this trial will be comparable to adjuvanted formulations delivered by needle and syringe,” CEO David Hoey says.

“In addition, if the adjuvanted HD-MAP formulation is safe and produces superior immune responses, it will open new opportunities to target a broader range of infectious diseases with HD-MAP vaccines.”

(Drug) delivering on the ASX

Vaxxas is vaunted as a mid-term ASX listing candidate, having raised a chunky $100 million in a private round in October last year.

The company declined to comment on its ASX intentions, but if it opts  for the local bourse it would join an existing cohort of ASX plays involved in alternative drug delivery.

LTR Pharma (ASX:LTP) is reformulating the active ingredient of most erectile dysfunction pills into an oral spray mist.

The product, Spontan has the same action as Viagra or Cialis, but with a much faster response time because the active ingredient hits the bloodstream faster.

LTR Pharma’s clinical study showed blokes are ready to go in nine to 15 minutes, as opposed to an average 56 minutes for the traditional pills.

Wellnex Life (ASX:WNX) has its own suite of brands, but is also the contract manufacturer for Haleon, formerly GSK,  which owns the Panadol brand.

That’s because Wellnex developed a liquid soft-gel paracetamol, similarly suitable for those who find it hard to swallow a hard tablet.

Last month, Wellnex won Australian marketing approval for the variants of a liquid paracetamol plus caffeine combo.

Earlier, Wellnex gained assent for gel-form liquid paracetamol, liquid paracetamol plus ibuprofen and liquid mini-ibuprofen.

Patrys (ASX:PAB) was – and is – using its proprietary antibody technology platform to develop therapies capable of crossing the blood-brain barrier to attack tumours.

The tech is licensed from Yale University and is applicable for cancer and non-cancer indications.

Not everything has delivered

“The ASX has its opportunities, but delivery systems don’t get much awareness in Australia,” Gelteq’s Givoni says.

“Money raising in Australia is not that easy. Opening it up to the US gave us a lot more capital.”

One reason may be that there has been a few ASX drug delivery ‘whoopsies’ along the way.

Take Suda, which developed an oral spray delivery platform called Oromist.

Suda won TGA approval for its insomnia treatment, Zolpimist. But failed to fire commercially.

These days, Suda is known as Arovella Therapeutics (ASX:ALA) and is developing unrelated cancer immunology treatments.

Phosphagenics had a skin beauty range based on tocopheryl phosphate mixture, TPM, to enable more efficient absorption through the skin.

The company fell victim to an infamous fraud perpetrated by CEO Esra Ogru and other parties.

Now called Avecho (ASX:AVE), the company has little resemblance to its predecessor, but TPM lives on. The substance is being used in Aveco’s phase II trial using cannabis to treat insomnia.

Patrys was charging towards a first-in-human, phase I study of its lead candidate PAT-DX1, but last year the program was halted because of problems with manufacturing the molecule to acceptable standards.

Luckily, the company has another candidate, PAT-DX3 which also seems capable of crossing the blood brain barrier.

Put in context, even Australia Post has trouble bringing home the goods at times.

Like the nation’s posties toiling through searing heat and driving rain – or both at once in the case of Queensland – the sector will not yield in its quest for the perfect drug delivery.