It’s the quarterly season again as the ASX market announcements page becomes increasingly flooded with update lodgements.
To save you the trouble of trudging through it all, we’ve wrapped up highlights from some of the reports in the ASX health sector that caught our eye.
LTR Pharma (ASX:LTP)
Highlights:
Pivotal clinical study of SPONTAN® fully recruited with dosing of all participants completed
SPONTAN achieves key manufacturing validation and first commercial batch production
Pivotal study enters data evaluation phase with results anticipated in mid-2024
LTP continued work to bring its erectile dysfunction (ED) nasal spray treatment SPONTAN to market during Q3 FY24. In its second trading update since its ASX listing on December 11, 2023 LTP says its pivotal clinical study of SPONTAN was fully recruited during the quarter with completed dosing of all participants.
LTP says the study into SPONTAN, – which is designed to be a world-first, fast-acting, on-demand nasal spray for ED – has entered the data evaluation phase, with results anticipated in mid-2024.
The study represents a critical milestone for the company as it is designed to show that SPONTAN can disrupt a class of drugs called PDE5 inhibitors, which include well-known Viagra.
Final data from the study is also expected to support the early access scheme in Australia and aid in pre-submission meetings with the US FDA and the TGA.
Furthermore, SPONTAN achieved key manufacturing validation and first commercial batch production during Q3 FY24.
“We are pleased to share that LTR Pharma has made significant strides towards bringing SPONTAN to market this quarter,” chairman Lee Rodne says.
“We completed the dosing phase of the pivotal study and met critical FDA requirements for manufacturing validation.
“We remain on track with a strong cash position to achieve our milestones and revolutionise the global erectile dysfunction treatment landscape.”
LTP had a cash balance of $5.28 million as at March 31, 2024.
Dimerix (ASX:DXB)
Highlights:
ACTION3 Phase 3 trial successfully passes first interim analysis using proteinuria efficacy endpoint
Dimerix completed $20 million institutional placement and raised a further $4.8 million from exercise of options
Post quarter end Dimerix received encouraging feedback from US FDA regarding its ACTION3 trial
The clinical stage biotech achieved a major milestone during Q3 FY24, announcing that its ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomised patients.
The analysis indicated that, using a statistical measure, DMX-200 is performing better than placebo in terms of reducing proteinuria (a surrogate marker of kidney disease progression) in patients with FSGS.
DXB’s ACTION3 clinical trial has now formally expanded into Part 2 of the study and to date, the study has randomised and dosed 98 patients with FSGS.
During the quarter DXB raised $20m via an institutional placement, which the company says resulted in a significant number of new institutional investors joining its register.
DXB also received ~$4.8 million in relation to the exercise of unlisted and listed options.
DXB is part of project PARASOL, an international effort aiming to establish the link between short-term biomarker changes (like proteinuria) and long-term outcomes for FSGS patients.
PARASOL also advocates for alternative proteinuria-based endpoints for faster FSGS kidney disease approval. DXB has been invited to attend industry workshops in June and October 2024.
DXB says the outcomes of PARASOL might impact the ACTION3 endpoints and the study’s statistical plan.
Post quarter end in April, DXB received correspondence from the US FDA. Among general trial conduct and regulatory related commentary the FDA noted PARASOL’s ongoing work and recommended that DXB continue the ACTION3 trial “to support a traditional approval based on an eGFR-based (estimated glomerular filtration rate) endpoint and/or other clinically meaningful endpoint(s)” while the PARASOL activities take place during 2024.
DXB says the FDA have “acknowledged the ongoing international effort [of PARASOL] to support the use of proteinuria as a basis for accelerated approval”.
DXB had a cash balance of $35.2 million as at March 31, 2024, up from $14.8 million at December 31, 2023.
Race Oncology (ASX:RAC)
Highlights:
RC220 manufacturing completed on-time to current Good Manufacturing Practice (cGMP) standards, enabling use in human clinical trials
Associate Professor Erin Howden appointed to scientific advisory board and Brendan Brown becomes chief financial officer
Early bonus option conversions and R&D tax refund increase RAC cash balance to $16.16 million
Clinical-stage biopharmaceutical company RAC has continued to make strong progress in Q3 FY24. RAC says the highlight of the quarter was the issuing of a Certificate of Analysis (CoA) for the first current Good Manufacturing Practice (cGMP) batch of 2600 vials of its proprietary bisantrene formulation, RC220.
The CoA confirms the new formulation meets the specifications required for a human intravenous (IV) drug product.
RAC also made key appointments during the quarter including Associate Professor Erin Howden of the Baker Institute to its scientific advisory board (SAB) and Brendan Brown of Prime Financial as chief financial officer.
The company says the appointments continue to strengthen Race as it advances bisantrene back into the clinic as a unique cardioprotective anticancer treatment.
Other key events for Q3 FY24 include receiving $4m via the (R&D) tax incentive from the Australian Taxation Office for FY23.
In March RAC scientists in collaboration with researchers from the University of Newcastle presented results from preclinical studies exploring bisantrene, both as a single drug and in combination with decitabine, as a new treatment for acute myeloid leukemia (AML) at the New Directions in Leukaemia Research conference in Adelaide.
RAC says of 31 March 2024, early exercise of 1.33 million bonus and piggyback options in the quarter contributed an additional $994k in new funding to support program advancement.
The company says corporate expenses continued to fall in Q3 FY24 as several high-cost initiatives concluded and administration expenses were reduced, enabling additional investments in value-building clinical and preclinical activities.
“The successful on-time manufacture of our cGMPRC220 bisantrene formulation was the most significant event in the quarter,” CEO Dr Daniel Tillett says.
“The team at Race worked exceptionally diligently to achieve this outstanding result which set us on a clear path back to the clinic in H2 2024.
“We are thankful for the continued support of our shareholders via the early exercise of the bonus and piggyback options.”
RAC’s cash and cash equivalents were $16.16m as at March 31, 2024 up from $2.44m at the end of Q2 FY24.
Neurotech (ASX:NTI)
Highlights:
Progress on several trials in Q3 FY24 including autism spectrum disorder, PANDAS/PANS and Spastic CP
Post quarter end NTI reported postive top line Phase 1/2 Rett Syndrome clinical trial results
In April NTI announced a $10 million capital raise with support from existing and new investors
Clinical-stage biotech NTI says it’s made significant progress on trials during Q3 FY24. The company has provided updates on progress of the 11 autism spectrum disorder (ASD) patients who were part of its Phase 1/2 clinical trial examining daily use of its proprietary broad spectrum cannabinoid drug therapy NTI164.
It says all patients have crossed 90 weeks of daily oral therapy with NTI164, with the drug continuing to exhibit an “exceptional safety and tolerability profile”. All patients showing stable blood chemistries and normal liver and kidney function over 90 weeks.
The company says it is the longest ever study in ASD examining the safety of a broad-spectrum cannabinoid drug treatment.
In February NTI provided an update on the open-label Phase 1/2 clinical trial of NTI164 in children diagnosed with Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), with all 15 patients entering into the 54-week extension phase of the trial in late August 2023.
The study showed a statistically significant and clinically meaningful improvement shown across a range of gold-standard, clinically validated assessments over 12 weeks of NTI164 treatment.
Data analysis undertaken at 24 weeks has shown continued improvements in patients with no adverse or serious adverse events recorded from 12-24 weeks.
In January NTI announced HREC approval and Clinical Trial Notification (CTN) scheme clearance by the TGA to start a Phase 1/2 clinical trial investigating the use of NTI164 in paediatric patients with Spastic Diplegia Cerebral Palsy (Spastic CP) the most common form of CP, representing up to 80% of cases.
Post-quarter end NTI reported positive top-line Phase 1/2 Rett Syndrome clinical trial results with its NTI164 being the first broad-spectrum cannabinoid drug therapy to show a statistically significant clinical improvement in Rett Syndrome patients, a leading cause of intellectual disability in girls.
In April NTI inked a binding term sheet with Fenix Innovation, a leading contract research organisation, based in Melbourne, to work exclusively with the company in the medicinal cannabis field with the development of NTI164 for neurological disorders.
NTI also announced this month it had received binding commitments for a $10m placement with support from existing and new institutional, professional and sophisticated Australian and overseas investors. The capital raised will be used to accelerate registration-directed activities, fund further clinical trials as required and manufacturing expansion.
The LTP, DXB,RAC & NTI share price today:
At Stockhead, we tell it like it is. While LTR Pharma, Dimerix, Race Oncology and Neurotech are Stockhead advertisers, they did not sponsor this article.
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